Research

JAMA | Original Investigation

Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults

With Type 1 Diabetes
A Randomized Clinical Trial
Richard E. Pratley, MD; Lauren G. Kanapka, MSc; Michael R. Rickels, MD, MS; Andrew Ahmann, MD;
Grazia Aleppo, MD; Roy Beck, MD, PhD; Anuj Bhargava, MD; Bruce W. Bode, MD; Anders Carlson, MD;
Naomi S. Chaytor, PhD; D. Steven Fox, MD, MPhil; Robin Goland, MD; Irl B. Hirsch, MD; Davida Kruger, MD;
Yogish C. Kudva, MD; Carol Levy, MD; Janet B. McGill, MD; Anne Peters, MD; Louis Philipson, MD, PhD;
Athena Philis-Tsimikas, MD; Rodica Pop-Busui, MD, PhD; Viral N. Shah, MD; Michael Thompson, MD;
Francesco Vendrame, MD; Alandra Verdejo, MPH; Ruth S. Weinstock, MD, PhD; Laura Young, MD, PhD;
Kellee M. Miller, PhD, MPH; for the Wireless Innovation for Seniors With Diabetes Mellitus (WISDM) Study Group

Visual Abstract
IMPORTANCE Continuous glucose monitoring (CGM) provides real-time assessment of Editorial page 2384
glucose levels and may be beneficial in reducing hypoglycemia in older adults with type 1
diabetes. Related article page 2388

Supplemental content
OBJECTIVE To determine whether CGM is effective in reducing hypoglycemia compared with
standard blood glucose monitoring (BGM) in older adults with type 1 diabetes. CME Quiz at
jamacmelookup.com
DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial conducted at 22 endocrinology
practices in the United States among 203 adults at least 60 years of age with type 1 diabetes.

INTERVENTIONS Participants were randomly assigned in a 1:1 ratio to use CGM (n = 103) or
standard BGM (n = 100).

MAIN OUTCOMES AND MEASURES The primary outcome was CGM-measured percentage of
time that sensor glucose values were less than 70 mg/dL during 6 months of follow-up. There
were 31 prespecified secondary outcomes, including additional CGM metrics for
hypoglycemia, hyperglycemia, and glucose control; hemoglobin A1c (HbA1c); and cognition
and patient-reported outcomes, with adjustment for multiple comparisons to control for
false-discovery rate.

RESULTS Of the 203 participants (median age, 68 [interquartile range {IQR}, 65-71] years;
median type 1 diabetes duration, 36 [IQR, 25-48] years; 52% female; 53% insulin pump use;
mean HbA1c, 7.5% [SD, 0.9%]), 83% used CGM at least 6 days per week during month 6.
Median time with glucose levels less than 70 mg/dL was 5.1% (73 minutes per day) at baseline
and 2.7% (39 minutes per day) during follow-up in the CGM group vs 4.7% (68 minutes per
day) and 4.9% (70 minutes per day), respectively, in the standard BGM group (adjusted
treatment difference, −1.9% (−27 minutes per day); 95% CI, −2.8% to −1.1% [−40 to −16
minutes per day]; P <.001). Of the 31 prespecified secondary end points, there were
statistically significant differences for all 9 CGM metrics, 6 of 7 HbA1c outcomes, and none of
the 15 cognitive and patient-reported outcomes. Mean HbA1c decreased in the CGM group
compared with the standard BGM group (adjusted group difference, −0.3%; 95% CI, −0.4%
to −0.1%; P <.001). The most commonly reported adverse events using CGM and standard
BGM, respectively, were severe hypoglycemia (1 and 10), fractures (5 and 1), falls (4 and 3),
and emergency department visits (6 and 8).

CONCLUSIONS AND RELEVANCE Among adults aged 60 years or older with type 1 diabetes,
continuous glucose monitoring compared with standard blood glucose monitoring resulted in Author Affiliations: Author
a small but statistically significant improvement in hypoglycemia over 6 months. Further affiliations are listed at the end of this
article.
research is needed to understand the long-term clinical benefit.
Group Information: Members of the
TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03240432 WISDM Study Group are listed at the
end of this article.
Corresponding Author: Richard E.
Pratley, MD, AdventHealth
Translational Research Institute,
301 E Princeton St, Orlando, FL
32789 (richard.pratley.md@
JAMA. 2020;323(23):2397-2406. doi:10.1001/jama.2020.6928 adventhealth.com).

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 Research Original Investigation Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes

T
he population of older adults with type 1 diabetes is
increasing because of advancements in diabetes care Key Points
leading to longer life expectancy.1 Older adults, par-
Question Is continuous glucose monitoring effective in reducing
ticularly those with long-standing type 1 diabetes, are prone hypoglycemia compared with standard blood glucose monitoring
to hypoglycemia and hypoglycemia unawareness. In addi- in older adults with type 1 diabetes?
tion to acute changes in mental status, severe hypoglycemia
Findings In this randomized clinical trial that included 203 adults
can cause seizures, falls leading to fractures, cognitive
aged 60 years or older with type 1 diabetes, treatment for 6
impairment, and cardiac arrhythmias resulting in sudden months with continuous glucose monitoring compared with
death. 2,3 Consequently, treatment guidelines for older standard blood glucose monitoring resulted in a significantly lower
adults with type 1 diabetes emphasize minimizing hypogly- percentage of glucose values less than 70 mg/dL (adjusted
cemia by having glucose levels less than 70 mg/dL less than difference, 1.9%).
1% of the time, and allow for less stringent hemoglobin A1c Meaning Among older adults with type 1 diabetes, continuous
(HbA1c) targets.4 Despite this, severe hypoglycemia remains glucose monitoring resulted in a small but statistically significant
a common complication.5 improvement in hypoglycemia over 6 months.
Continuous glucose monitoring (CGM) measures intersti-
tial glucose concentrations, allowing for near real-time
assessment of glucose levels and trends. Continuous glucose Each participant completed a 2-week prerandomization pe-
monitors can provide alerts when glucose levels exceed low riod using a masked CGM on which sensor glucose concentra-
or high thresholds or are changing rapidly, allowing patients tions were not visible to participants. To be eligible for ran-
to adjust insulin dosing or consume carbohydrates to mini- domization, participants were required to have at least 10 of
mize the risk of hypoglycemia. The US Food and Drug 14 days (240 hours) of data available with an average of at least
Administration now allows certain continuous glucose moni- 1.8 calibrations per day using the study-provided blood glu-
tors to be used in place of standard capillary blood glucose cose meter (Bayer Contour Next USB; Ascensia Diabetes Care).
monitoring (BGM) for diabetes treatment decisions.6 Several
randomized trials have demonstrated the efficacy of CGM in Intervention and Procedures
adults with type 1 diabetes.7-10 However, none have included Eligible participants were randomly assigned in a 1:1 ratio via
a substantial number of older individuals,7,11-14 and most a computer-generated sequence to use of CGM (Dexcom G5,
have excluded patients with recent severe hypoglycemia or Dexcom) with a study blood glucose meter as needed or to use
hypoglycemia unawareness. Thus, the benefits of CGM found the study blood glucose meter without CGM, using a per-
in prior studies cannot be generalized to older adults with muted block design (block sizes of 2 and 4), stratified by site.
type 1 diabetes, who are at high risk of hypoglycemia and its Participants in both groups were provided general diabe-
complications. This trial was conducted with the primary tes management education, and clinicians were encouraged
goal of assessing whether CGM was effective in reducing to review downloaded glucose data at each visit to inform treat-
hypoglycemia compared with standard BGM in older adults ment recommendations at their discretion. The standard BGM
with type 1 diabetes. group was asked to perform home BGM at least 4 times daily.
The CGM group was instructed to use the continuous glucose
monitor daily, to calibrate the monitor twice daily, and to set
the low alert (recommended to be set at 70 mg/dL). The con-
Methods tinuous glucose monitor includes an urgent low alert at
Trial Design and Oversight 55 mg/dL that cannot be turned off. General guidelines were
This randomized clinical trial was conducted at 22 endocrinol- provided to participants about using CGM. Additional instruc-
ogy practices in the United States. The protocol and informed tions were provided on using CGM trend arrows to adjust in-
consent forms were approved by institutional review boards. sulin dosing based on guidelines specific to an at-risk older
Written informed consent was obtained from each participant adult population (eAppendix in Supplement 2).15
prior to enrollment. An independent data and safety monitor- Both groups had clinic visits 4, 8, 16, and 26 weeks follow-
ing board provided trial oversight reviewing unmasked safety ing randomization. In addition, the standard BGM group was
data during the conduct of the study. The final protocol and sta- seen in clinic at weeks 7, 15, and 25 for placement of a masked
tistical analysis plan are available in Supplement 1. CGM (same algorithm as the CGM group’s real-time CGM),
which was worn for 1 week.
Participants Hemoglobin A 1c was measured at randomization, 16
Major eligibility criteria included a clinical diagnosis of type 1 weeks, and 26 weeks at the University of Minnesota using the
diabetes, age of at least 60 years, no use of real-time CGM in the Tosoh A1c 2.2 Plus Glycohemoglobin Analyzer. Participants
3 months prior to enrollment, and an HbA1c of less than 10.0%. completed patient-reported outcome and cognitive assess-
Participants were required to be using either an insulin pump ments at the randomization and 26-week clinic visits.
or multiple daily insulin injections, and an enrollment target was
set to include at least 40% of participants using each mode of Data Collection and Outcomes
insulin delivery. A complete list of the inclusion and exclusion Participant sociodemographic data, including fixed catego-
criteria is available in eTable 1 in Supplement 2. ries for race/ethnicity, were collected from medical records and

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 Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes Original Investigation Research

confirmed by participants to better describe the study cohort

Figure 1. Flow of Participants in the Wireless Innovation for Seniors
and to address generalizability. With Diabetes Mellitus (WISDM) Study
The primary outcome was CGM-measured percentage of
time spent with a glucose value less than 70 mg/dL during 219 Patients assessed for eligibilitya
follow-up using data pooled from approximately 7 days prior
to the 8, 16, and 26-week visits. (To convert glucose values to 16 Excluded
millimoles per liter, multiply by 0.0555.) Prespecified sec- 7 Did not meet inclusion criteria
8 Declined to participate
ondary hypoglycemia outcomes included percentage of time 1 Did not meet run-in criteriab
with a glucose value less than 54 mg/dL, percentage of
time with a glucose value less than 60 mg/dL, and rate
203 Randomized
of hypoglycemia events per week (with an event defined
as 15 consecutive minutes with a sensor glucose value
<54 mg/dL). Prespecified secondary hyperglycemia out- 103 Randomized to use CGM 100 Randomized to use standard BGM
103 Used CGM as randomized 100 Used standard BGM as
comes included percentages of time with glucose values randomized
greater than 180 mg/dL, greater than 250 mg/dL, and greater
than 300 mg/dL. Prespecified glycemic control outcomes 1 Lost to follow-up 1 Lost to follow-up
included percentage of time with glucose values in the range 3 Requested to withdraw from study
2 Discontinued interventionc
of 70 to 180 mg/dL, mean glucose, and glycemic variability
(coefficient of variation, defined as ratio of the standard
103 Included in primary analysisd 100 Included in primary analysisd
deviation to the mean). Prespecified secondary HbA1c out-
comes included mean change from baseline, percentage
Enrollment took place from September 2017 to May 2018, and study follow-up
with HbA1c less than 7.0%, percentage with HbA1c less than for the randomized trial continued through December 2018. BGM indicates
7.5%, percentage with relative reduction in HbA 1c of at blood glucose monitoring; CGM, continuous glucose monitoring.
a
least 10%, percentage with absolute reduction in HbA 1c Information on patients screened but not enrolled was not collected.
b
of at least 0.5%, percentage with absolute reduction in HbA1c One patient was excluded for having both a history of at least 1 severe
of at least 1%, and percentage with absolute reduction in hypoglycemia event in the past 6 months and spending more than 10% of
time with CGM glucose levels less than 54 mg/dL during the blinded
HbA1c of at least 0.5% or HbA1c less than 7.0%. prerandomization phase.
Additional prespecified secondary participant-reported c
Two participants in the standard BGM group initiated real-time CGM before
outcomes included general quality of life (PROMIS Global completing the 26-week visit.
Health Short Form; National Institutes of Health [NIH] Tool- d
One participant in the CGM group and 6 participants in the standard BGM
box [http://www.nihtoolbox.org] Emotion Battery), hypo- group were missing CGM data at follow-up. Missing data were handled
using direct likelihood. Baseline data for these participants were included
glycemia awareness (Clarke Survey16), hypoglycemia fear
in the model.
(Hypoglycemia Fear Survey II–Worry subscale17), and diabe-
tes distress (Type 1 Diabetes Distress Scale18). Descriptions
of these outcomes, scoring, and clinically relevant change dard deviation of 5%, a type I error rate (2-sided) of 5%, and
(when known) are shown in eTable 2 in Supplement 2. 10% missing follow-up data.
Cognitive performance also was assessed at baseline and 26 Participants were analyzed according to their randomiza-
weeks using the NIH Toolbox Cognition Battery; specifics on tion group, and all participants were included in the primary
this measure and training of study personnel are also analysis. For the primary analysis, the difference in percent-
described in eTable 2. age of time spent with a glucose value less than 70 mg/dL at
Reportable adverse events included severe hypoglyce- follow-up between the 2 treatment groups was assessed in a
mia (defined as an event that required assistance from longitudinal linear regression model including baseline and
another person because of altered consciousness), hypergly- follow-up data and clinical center as a random effect. Missing
cemia resulting in treatment at a health care facility or that data were handled by direct likelihood, which maximizes the
involved diabetic ketoacidosis (as defined by the Diabetes likelihood function integrated over possible values of the miss-
Control and Complications Trial19), device-related events ing data.20 The analyses for the secondary continuous out-
with potential effect on participant safety, falls, fractures, comes paralleled those for the primary outcome. Binary HbA1c
emergency department visits, and all serious adverse events outcomes were compared between treatment groups using
regardless of causality. available cases only in a logistic regression model adjusting for
baseline HbA1c and clinical center as a random effect.
Statistical Analysis Modification of the treatment effect by baseline variables
A sample size of 200 participants was determined to have at was assessed by including an interaction term in the primary
least 90% power to detect a reduction in percentage of time model. Sensitivity analyses were performed as described in the
spent with a glucose value less than 70 mg/dL for the overall statistical analysis plan (adjustment for potential confound-
cohort and a minimum of 80% power for an a priori subgroup ing of baseline imbalances and including only participants
analysis by insulin delivery method, assuming a population meeting per-protocol criteria) (Supplement 1).
relative treatment reduction of 50% from a percentage of time Analysis of all outcomes was repeated separately among
spent with a glucose value less than 70 mg/dL of 6%, a stan- insulin pump and injection users and paralleled the overall

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 Research Original Investigation Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes

Table 1. Baseline Characteristics of Study Participants

Continuous glucose monitoring Blood glucose monitoring
Characteristics (n = 103) (n = 100)
Age, y
No. (%)
<70 70 (68) 67 (67)
≥70 33 (32) 33 (33)
Median (IQR) [range] 68 (65-72) [60-83] 67 (64-71) [60-86]
Diabetes duration, median (IQR) [range], y 39 (24-49) [0.9-64.7] 36 (25-47) [0.2-70.7]
Age at diagnosis, median (IQR), y 30 (19-47) 31 (19-43)
Sex, No. (%)
Female 61 (59) 44 (44)
Male 42 (41) 56 (56)
Race/ethnicity, No. (%) n = 101 n = 100
White, non-Hispanic 93 (92) 94 (94)
Black, non-Hispanic 4 (4) 2 (2)
Hispanic or Latino 1 (<1) 4 (4)
Asian 1 (<1) 0
>1 Race 2 (2) 0
Annual household income, $, No. (%) n = 70 n = 72
<50 000 14 (20) 25 (35)
50 000 to <100 000 34 (49) 27 (38)
≥100 000 22 (31) 20 (28)
Highest education, No. (%) n = 101 n = 100
Less than a bachelor’s degree 31 (31) 46 (46)
Bachelor’s degree 35 (35) 28 (28)
Graduate or professional degree 35 (35) 26 (26)
Health insurance, No. (%)
Private 30 (29) 27 (27)
Private and Medicare 37 (36) 33 (33)
Medicare/other 36 (35) 40 (40)
Continuous glucose monitor use, No. (%)
Past but not current 53 (51) 40 (40)
Never 50 (49) 60 (60)
Insulin pump use, No. (%) 58 (56) 50 (50)
Screening HbA1c, mean (SD) [range], %a 7.6 (1.0) [5.4-10.0] 7.5 (0.9) [5.7-9.8]
HbA1c at randomization, %b n = 100 n = 97
No. (%)
<8.0 72 (72) 71 (73)
≥8.0 28 (28) 26 (27)
Mean (SD) [range] 7.6 (0.9) [5.6-10.8] 7.5 (0.8) [5.7-9.6]
Detectable C-peptide, No. (%)c 24 (23) 22 (22)
Total daily insulin doses per kg, median (IQR) 0.5 (0.4-0.6) [n = 97] 0.5 (0.4-0.7) [n = 95]
≥1 Severe hypoglycemia event in the past 12 mo, No. (%)d 20 (19) 10 (10)
≥1 Diabetic ketoacidosis event in the past 12 mo, No. (%)e 5 (5) 3 (3)
Functional Activities Questionnaire score, No. (%)f n = 100 n = 96
<8 98 (98) 86 (90)
≥8 2 (2) 10 (10)
NIH Toolbox Cognition Battery age-corrected 96 (13) [67-122] [n = 100] 94 (14) [64-137] [n = 97]
fluid composite score, mean (SD) [range]g
Cognition status measured by NIH Toolbox n = 100 n = 97
Cognition Battery, No. (%)g
No cognitive impairment 84 (84) 81 (84)
Clinically significant cognitive impairment 16 (16) 16 (16)

(continued)

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 Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes Original Investigation Research

Table 1. Baseline Characteristics of Study Participants (continued)

Continuous glucose monitoring Blood glucose monitoring
Characteristics (n = 103) (n = 100)
Reduced hypoglycemia awareness, No. (%)h n = 100 n = 99
Yes (Clarke Survey score ≥4) 32 (32) 29 (29)
No (Clarke Survey score ≤3) 68 (68) 70 (71)
Wearing hearing aids regularly, No. (%) 8 (8) 12 (12)
Near vision card (corrected) last line read 10 (10) 12 (12)
worse than 20/40, No. (%)

Abbreviations: HbA1c, hemoglobin A1c; IQR, interquartile range; NIH, National Institutes of Health.
a
Screening HbA1c measured by point-of-care device or at local laboratory and used to determine eligibility.
b
Randomization HbA1c measured by central laboratory.
c
Random C-peptide measured by central laboratory. The detection limit of the assay was 0.003 nmol/L. The presence of
detectable C-peptide is an indicator that the pancreas is capable of at least some insulin production.
d
Severe hypoglycemia was defined as an event that required the assistance of another person to administer
carbohydrate, glucagon, or other resuscitative actions because of altered consciousness.
e
A diabetic ketoacidosis event was defined as an episode in which a participant had ketosis that necessitated treatment in
a health care facility.
f
Score ranges from 0 to 30, with higher scores reflecting greater dependence in instrumental activities of daily living
(<8 is indicative of dementia based on Juva et al26).
g
Clinically significant cognitive impairment was defined as 2 or more age-corrected scores of 80 or lower on the following
NIH Toolbox Cognition Battery instruments: Flanker Inhibitory Control and Attention, List Sorting Working Memory,
Dimensional Change Card Sort, Pattern Comparison Processing Speed, and Picture Sequence Memory.27
h
The Clarke method of assessing hypoglycemia awareness ranges from 0 to 8, with higher scores reflecting lower
awareness.16

analysis described above. Additional analyses also were per- cluded 1 participant who had dropped out. Use of CGM was
formed for data collected through 16 weeks and data col- similar between those who used a pump and those who used
lected separately during daytime (6:00 AM to 11:59 PM) and injections for insulin delivery (eTable 9 in Supplement 2). Two
nighttime (12:00 AM to 5:59 AM) hours for CGM outcomes. participants in the standard BGM group initiated real-time CGM
For all secondary analyses, 2-sided P values and 95% use during the trial.
confidence intervals were adjusted for multiple compari- Blood glucose self-monitoring, measured as the median
sons to control the false-discovery rate using the adaptive of individuals’ mean number of tests per day, was 5.0 (inter-
Benjamini-Hochberg procedure 21 (eTable 3 in Supple- quartile range [IQR], 4.0-6.0) in the CGM group and 4.0 (IQR,
ment 2). Analyses were conducted with SAS software ver- 3.0-5.5) in the standard BGM group during the baseline pe-
sion 9.4 (SAS Institute Inc). riod of blinded CGM wear, and was 3.5 (IQR, 2.8-4.5) and 4.3
(IQR, 3.8-5.0), respectively, during follow-up.

Glycemic Control Outcomes

Results In the primary analysis, median percentage of time with glu-
Between October 2017 and June 2018, 203 participants were cose levels less than 70 mg/dL decreased from 5.1% (73 min-
randomly assigned to the CGM group (n = 103) or the stan- utes per day) at baseline to 2.7% (39 minutes per day) during
dard BGM group (n = 100). Sixteen patients who provided con- the 6 months of follow-up for the CGM group and remained
sent and were screened for the study did not proceed into the relatively unchanged from 4.7% (68 minutes per day) at base-
randomized clinical trial (Figure 1). Participant characteris- line to 4.9% (70 minutes per day) during follow-up for the
tics overall and according to randomization group are shown standard BGM group, for an adjusted treatment group differ-
in Table 1 and additionally stratified by insulin delivery method ence of −1.9% (95% CI, −2.8% to −1.1%; P <.001), correspond-
in eTable 4 in Supplement 2. Participant comorbidities and ing to a significant reduction in hypoglycemia of 27 minutes
medications are reported in eTables 5 and 6 and in Supple- per day (95% CI, −40 to −16 minutes per day; P <.001)
ment 2, respectively. (Table 2 and eTable 10 and eFigure 2 in Supplement 2).
The 26-week visit was completed by 102 participants in Results were similar for other CGM hypoglycemia metrics
the CGM group (99%) and by 96 participants in the standard (Table 2 and eTable 10). The significant treatment effect was
BGM group (96%) (Figure 1 and eFigure 1 in Supplement 2). evident in the first month and remained consistent over 6
Unscheduled visits and contacts are reported in eTable 7 in months (Figure 2A and eTable 11 in Supplement 2). Results
Supplement 2. were similar in a sensitivity analyses that adjusted for charac-
In the CGM group, CGM use was high throughout the study teristics with some imbalance at baseline (duration of diabe-
(eTable 8 in Supplement 2). In the 4 weeks prior to the 26- tes, sex, education, severe hypoglycemia in the 12 months
week visit, 81% were wearing the device 7 days per week and prior to the study, and functional activity [questionnaire
89% 5 or more days per week; 6% had zero use, which in- score]) and in a per-protocol sensitivity analysis (eTable 12 in

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 Research Original Investigation Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes

Table 2. Glycemic Outcomes

Baseline Follow-up (8, 16, and 26 wk pooled)a Adjusted difference,

CGM Standard BGM CGM Standard BGM CGM − standard BGM
Outcomes (n = 103) (n = 100) (n = 102) (n = 94) (95% CI)b P valueb
Primary outcome
Time with glucose <70 mg/dL, % 5.1 (3.0-9.7) 4.7 (2.4-9.5) 2.7 (1.6-4.6) 4.9 (2.5-8.5) −1.9 (−2.8 to −1.1) <.001
Secondary continuous glucose monitoring outcomes
Hours of CGM data, median (IQR) 324 (308-388) 327 (309-397) 473 (449-489) 465 (423-483)
Hypoglycemia, median (IQR)
Time with glucose <60 mg/dL, % 3.0 (1.5-5.5) 2.4 (1.1-5.9) 0.9 (0.5-1.9) 2.4 (0.8-5.1) −1.4 (−2.0 to −0.8) <.001
Time with glucose <54 mg/dL, % 1.9 (0.9-3.6) 1.5 (0.5-4.1) 0.5 (0.2-1.0) 1.6 (0.4-3.4) −1.0 (−1.4 to −0.5) <.001
Rate of hypoglycemia events per wkc 2.6 (1.5-3.9) 2.1 (0.9-4.1) 0.8 (0.3-2.2) 1.8 (0.7-4.0) −0.9 (−1.3 to −0.5) <.001
Time with glucose in range of 70-180 mg/dL, 56 (13) 56 (14) 63 (13) 54 (14) 8.8 (6.0 to 11.5) <.001
mean (SD), %
Glucose level, mean (SD), mg/dL 167 (29) 168 (31) 162 (23) 171 (30) −7.7 (−13.1 to −2.4) .005
Coefficient of variation, mean (SD), %d 41 (6) 42 (7) 37 (5) 42 (7) −4.7 (−6.1 to −3.3) <.001
Hyperglycemia
Time with glucose >180 mg/dL, 37 (16) 38 (17) 34 (14) 39 (16) −5.8 (−8.8 to −2.8) <.001
mean (SD), %
Time with glucose >250 mg/dL, 10 (6-21) 13 (5-20) 9 (3-15) 13 (8-23) −3.6 (−5.2 to −2.2) <.001
mean (SD), %
Time with glucose >300 mg/dL, 3.8 (1.5-8.5) 4.2 (1.3-9.4) 2.4 (0.6-5.2) 5.2 (2.2-9.4) −1.7 (−2.5 to −0.9) <.001
median (IQR), %
Secondary HbA1c outcome
HbA1c, mean (SD), %e 7.6 (0.9) [n = 100] 7.5 (0.8) [n = 97] 7.2 (0.9) [n = 100] 7.4 (0.9) [n = 95] −0.3 (−0.4 to −0.1) <.001
Abbreviations: BGM, blood glucose monitoring; CGM, continuous glucose and Lehmann.28 P values and 95% confidence intervals for all secondary
monitoring; HbA1c, hemoglobin A1c; IQR, interquartile range. outcomes were adjusted for multiple comparisons to control the
SI conversion: To convert glucose values to millimoles per liter, multiply by false-discovery rate.
c
0.0555. A CGM-measured hypoglycemia event was defined as 15 consecutive minutes
a
One participant in the CGM group and 6 participants in the standard BGM with a sensor glucose value less than 54 mg/dL. The end of the hypoglycemia
group were missing CGM data at follow-up. Missing data were handled event was defined as a minimum of 15 consecutive minutes with a sensor
using direct likelihood. Baseline data for these participants were included glucose concentration greater than 70 mg/dL.4
d
in the model. Coefficient of variation is defined as standard deviation divided by mean.
b e
Outcomes were analyzed in a linear mixed-effects model that adjusted for Three participants in both groups were missing central laboratory HbA1c data
baseline value of the outcome being assessed and clinical center as a random at baseline. Three participants in the CGM group and 5 participants in the
effect. The hypoglycemia metrics, time spent with glucose concentrations standard BGM group were missing central laboratory HbA1c data at 26 weeks.
greater than 250 mg/dL and greater than 300 mg/dL, had skewed All participants had a least 1 central laboratory value and were included in the
distributions and were modeled using a rank-based transformation. For these model for those time points. Missing data were handled using direct
skewed outcomes, point estimates and confidence intervals for the treatment likelihood.
group difference were calculated using the technique described by Hodges

Supplement 2). A significant benefit of CGM in reducing time the target range of 70 to 180 mg/dL was 8.8% (2.1 hours per
with glucose levels less than 70 mg/dL was observed both dur- day) higher in the CGM group compared with the standard BGM
ing daytime and overnight (Figure 2B and eTable 13 in Supple- group (95% CI, 6.0%-11.5% [1.4-2.8 hours per day]; P <.001)
ment 2) and was present for both insulin pump and injection (Table 2 and eTable 10). Mean HbA1c was 7.6% (SD, 0.9%) at
users (eTables 14 and 15 in Supplement 2). The treatment ef- baseline and 7.2% (SD, 0.9%) at 26 weeks in the CGM group
fect was significantly greater in participants with higher lev- and 7.5% (SD, 0.8%) and 7.4% (SD, 0.9%), respectively, in the
els of baseline time with glucose levels less than 70 mg/dL, with standard BGM group (adjusted group difference, −0.3%; 95%
a higher coefficient of variation, and with presence of a de- CI, 0.4% to −0.1%; P <.001) (Table 2). Additional HbA1c met-
tectable C-peptide level (P <.001 for interaction for each). There rics are shown in eTable 17 in Supplement 2.
was no significant interaction of the treatment effect on time
with glucose levels less than 70 mg/dL with respect to other Severe Hypoglycemia and Other Adverse Events
baseline characteristics, including age (<70 vs ≥70 years), so- One participant in the CGM group and 10 participants in the
cioeconomic status, presence of cognitive impairment, or HbA1c standard BGM group experienced a severe hypoglycemia event
value (eTable 16 in Supplement 2). during the 6 months of follow-up (Table 3). Five of the 10 par-
In addition to the reduction in hypoglycemia with CGM, ticipants (50%) in the standard BGM group had an event that
significant treatment group differences were observed for hy- involved seizure or loss of consciousness, which did not oc-
perglycemia (glucose levels >180 mg/dL, >250 mg/dL, and cur in the 1 CGM participant.
>300 mg/dL), mean glucose concentration, and glycemic vari- One episode of diabetic ketoacidosis occurred during the
ability (Table 2 and eTable 10 in Supplement 2). Time spent in study in a participant in the CGM group, unrelated to use of

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 Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes Original Investigation Research

Figure 2. Percentage of Time Spent With Less Than 70 mg/dL by Study Visit and Time of Day

A By study visit B By time of day

Continuous glucose Standard blood
35 monitoring glucose monitoring 20 Continuous glucose monitoring (n = 102)
Time spent with glucose level <70 mg/dL, %

Time spent with glucose level <70 mg/dL, %

Standard blood glucose monitoring (n = 94)
30

15
25

20
10
15

10
5

0 0

Baseline 8 wk 16 wk 26 wk 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11
AM PM PM
Study visit
No. of participants
Time of day
103 100 100 92 101 93 97 91

To convert glucose values to millimoles per liter, multiply by 0.0555. A, By study indicate 25th and 75th percentiles and thicker lines, medians. Participants with
visit: tops and bottoms of boxes indicate 25th and 75th percentiles; lines, follow-up continuous glucose monitoring data had a minimum of 48 readings
medians; solid cirles, means; whiskers, minimums and maximums after and maximum of 420 readings used to calculate percentage of time spent with
removing outliers; and open circles, outliers. B, By time of day: thinner lines glucose levels less than 70 mg/dL for each hour of the day.

Table 3. Safety Outcomes: Severe Hypoglycemia and Other Adverse Events

Participants with ≥1 event,
No./total Incidence rate
CGM Standard BGM
Incidence rate Incidence rate Difference,
Standard Total No. of per 100 Total No. of per 100 CGM − standard BGM
Outcomes CGM BGM person-years person-years person-years person-years (95% CI)a P valuea
Severe hypoglycemia
eventsb,c
Overall 1/103 10/100 51.5 1.9 49.1 22.4 −20.4 (−34.6 to −6.3) .02
Insulin pump usersd 1/56 4/49 28.2 3.5 24.1 16.6
Insulin injection usersd 0/45 5/48 22.3 0.0 23.5 25.5
Other adverse eventsc
Diabetic ketoacidosis 1/103 0/100 51.5 1.9 49.1 0.0
Fractures 5/103 1/100 51.5 13.6 49.1 2.0 11.6 (−1.3 to 24.5) .08
Falls 4/103 3/100 51.5 11.7 49.1 6.1 5.6 (−9.0 to 20.1) .36
Hospitalizations 3/103 2/100 51.5 9.7 49.1 4.1 5.6 (−8.0 to 19.3) .30
Emergency department 6/103 8/100 51.5 11.7 49.1 16.3 −4.6 (−18.8 to 9.5) .53
visits
Device-related events 0/103 0/100 51.5 0.0 49.1 0.0
b
Abbreviations: BGM, blood glucose monitoring; CGM, continuous glucose Five of the 10 participants with severe hypoglycemia events (50%) in the
monitoring. standard BGM group had an event that involved seizure or loss of
a
If there were enough events for analysis, safety outcomes for the overall consciousness, which did not occur in the 1 CGM participant with an event.
c
cohort were compared between treatment groups using Poisson regression Each event can be counted in more than 1 category; ie, a fracture may also be
with the number of events as the outcome and the number of follow-up years included as a hospitalization.
as an offset. The model for severe hypoglycemia events was also adjusted for d
Participants who switched insulin delivery modes were not included in the
whether a participant had an event in the 12 months prior to the study. stratified analyses.
Confidence intervals for treatment group difference of incidence rate were
calculated using bootstrapping.

CGM (Table 3). There were no statistically significant treat- Patient-Reported Outcomes and Cognitive Assessments
ment group differences in fractures, falls, hospitalizations, or No significant treatment group differences were observed
emergency department visits. at 26 weeks for any of the participant-reported question-
There were 22 CGM device issues reported over the 26- naires or cognitive assessments, including measures of
week follow-up (eTable 18 in Supplement 2), none of which hypoglycemia awareness, diabetes-specific quality of life (hy-
were related to an adverse event. poglycemia fear, diabetes distress, and glucose monitoring

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 Research Original Investigation Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes

satisfaction), general quality of life, and cognition (eTable 19 The strengths of this study include random treatment as-
in Supplement 2). signment, high participant retention rate, high degree of CGM
use by the CGM group, and only 2 treatment crossovers by the
standard BGM group. Although treatment group assignment
could not be masked, the amount of contact with partici-
Discussion pants was similar between groups.
Among adults aged 60 years or older with type 1 diabetes, use
of CGM resulted in a small but statistically significant reduc- Limitations
tion in time spent with hypoglycemia (glucose level less than This study has several limitations. First, the study cohort had
70 mg/dL) compared with periodic finger-stick monitoring using relatively high socioeconomic status and consisted of indi-
standard BGM. A similar degree of hypoglycemia reduction was viduals receiving specialized diabetes care. On average, base-
seen in those using insulin pump therapy and those using mul- line glycemic control was good and the amount of biochemi-
tidose insulin injection therapy. Results were consistent across cal hypoglycemia was modest. Median age at diagnosis was
the age range of 60 to 86 years, across the baseline HbA1c range 30 years, but the treatment effect appeared similar irrespec-
of 5.6% to 10.8%, among those with and without cognitive im- tive of age at diagnosis. Second, there was a relatively short
pairment, and at all education levels. The higher the amount intervention period of 6 months. This study included an
of baseline hypoglycemia and glycemic variability, risk factors extension phase during which the CGM group continued
for severe hypoglycemia in older adults with type 1 diabetes,22 using CGM through 12 months and the standard BGM group
the greater the treatment effect. In this study, the risk of a se- initiated CGM. Results of the extension phase may provide
vere hypoglycemia event was significantly reduced with use of insight into longer-term use of CGM. Third, the study inter-
CGM, but the majority of participants using CGM did not achieve vention used an older version of the CGM sensor than what is
the less-than-1% target for time with a glucose level less than now commercially available. It is unknown whether the addi-
70 mg/dL recommended for older adults.23 tional features of the newer CGM sensor (such as no calibra-
Reducing time with a glucose level less than 70 mg/dL is tion requirement, easier insertion process, and a predictive
important, as it has been associated with risk of a subsequent low glucose alert) would have further increased CGM use in
severe hypoglycemia event, demonstrating the potential for this population. Fourth, the study intervention also did not
clinical importance.4,8 However, further research of longer du- include a system that suspends insulin delivery from a pump
ration and with clinical outcomes is needed before reaching when hypoglycemia is predicted based on the CGM glucose
any conclusions about the clinical value of these findings. readings. Such a system for pump users might have an even
Despite improvements in various measures of hypoglyce- greater effect on reducing hypoglycemia than was seen in
mia and glycemic control and the high degree of CGM use after this study.24,25 Fifth, by chance, the CGM group had a higher
6 months, there were no significant treatment group differ- frequency of severe hypoglycemia events in the year prior to
ences in patient-reported outcomes, including fear of hypogly- the study than the standard BGM group; adjusting for this
cemia and diabetes distress. One possible explanation is that the factor did not alter the result.
baseline scores on these measures were quite low, indicating al-
ready good adjustment to managing diabetes.
The findings in this trial are consistent with a subgroup
analysis of the participants in the DIAMOND study, who were
Conclusions
aged 60 years or older, with respect to the high degree of CGM Among adults aged 60 years or older with type 1 diabetes, CGM
use after 6 months and the benefit of CGM on reducing hyper- compared with standard BGM resulted in a small but statisti-
glycemia and HbA1c; however, the DIAMOND cohort had too cally significant improvement in hypoglycemia over 6 months.
little baseline hypoglycemia for a meaningful assessment of Further research is needed to understand the long-term clini-
the effect of CGM on hypoglycemia.9,14 cal benefit.

ARTICLE INFORMATION Medicine, Washington State University, Spokane Colorado Anschutz Medical Campus, Aurora (Shah);
Accepted for Publication: April 16, 2020. (Chaytor); University of South California, School of University of Massachusetts Medical School,
Pharmacy, Los Angeles (Fox); Naomi Berri Diabetes Worcester (Thompson); University of Miami, Miami,
Author Affiliations: AdventHealth Translational Center, Columbia University, New York, New York Florida (Vendrame); SUNY Upstate Medical
Research Institute, Orlando, Florida (Pratley); Jaeb (Goland); University of Washington, Seattle University, Syracuse, New York (Weinstock);
Center for Health Research, Tampa, Florida (Hirsch); Henry Ford Health System, Detroit, University of North Carolina at Chapel Hill, Chapel
(Kanapka, Beck, Verdejo, Miller); Rodebaugh Michigan (Kruger); Mayo Clinic, Rochester, Hill (Young).
Diabetes Center, University of Pennsylvania Minnesota (Kudva); Icahn School of Medicine at
Perelman School of Medicine, Philadelphia Author Contributions: Dr Miller had full access to
Mount Sinai, New York, New York (Levy); all of the data in the study and takes responsibility
(Rickels); Oregon Health and Science University, Washington University School of Medicine in St
Portland (Ahmann); Feinberg School of Medicine, for the integrity of the data and the accuracy of the
Louis, St Louis, Missouri (McGill); Keck School of data analysis.
Northwestern University, Chicago, Illinois (Aleppo); Medicine, University of Southern California, Los
Iowa Diabetes and Endocrinology Research Center, Concept and design: Pratley, Rickels, Ahmann,
Angeles (Peters); University of Chicago, Chicago, Aleppo, Beck, Carlson, Chaytor, Fox, Goland, Hirsch,
Des Moines (Bhargava); Atlanta Diabetes Illinois (Philipson); Scripps Whittier Diabetes
Associates, Atlanta, Georgia (Bode); Park Nicollet Kruger, Kudva, Peters, Pop-Busui, Shah, Verdejo,
Institute, La Jolla, California (Philis-Tsimikas); Miller.
International Diabetes Center, Minneapolis, University of Michigan, Ann Arbor (Pop-Busui);
Minnesota (Carlson); Elson S. Floyd College of Acquisition, analysis, or interpretation of data:
Barbara Davis Center for Diabetes, University of

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 Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes Original Investigation Research

Pratley, Kanapka, Rickels, Ahmann, Aleppo, personal fees from Dexcom. Dr Levy reported MD (PI); Richard Bergenstal, MD (I); Marcia
Bhargava, Bode, Carlson, Chaytor, Fox, Goland, receipt of nonfinancial support from Dexcom. Madden, MPH, RN, CNP, CDE (I); Thomas Martens,
Hirsch, Kruger, Kudva, Levy, McGill, Peters, Dr McGill reported receipt of personal fees from MD (I); Sean Dunnigan, RN (PC); Kathleen McCann,
Philipson, Philis-Tsimikas, Pop-Busui, Shah, Aegerion, Bayer, Boehringer Ingelheim, Gilead, Lilly, RN (C); University of Washington Diabetes Care
Thompson, Vendrame, Weinstock, Miller. Metavant, Valeritas, Janssen, Mannkind, the Center, Seattle: Irl Hirsch, MD (PI); Dace Trence, MD,
Drafting of the manuscript: Pratley, Kanapka, Endocrine Society, the American Association of FACE (I); Subbulaxmi Trikudanathan, MD, MRCP,
Rickels, Carlson, Kudva, Peters, Philis-Tsimikas, Clinical Endocrinologists, Culinary Medicine, Novo MMSc (I); Lorena Wright, MD (I); Andrea Toulouse,
Thompson, Miller. Nordisk, and Dexcom; grants from Novo Nordisk, MS (PC); Dori Khakpour, RDN, CD, CDE (C); Lori
Critical revision of the manuscript for important Dexcom, Medtronic, Novartis, AstraZeneca, and the Sameshima, RN (C); Nancy Sanborn, ND, CDE (C)
intellectual content: Pratley, Kanapka, Rickels, NIH; and nonfinancial support from Bayer, Naomi Berrie Diabetes Center, Columbia University,
Ahmann, Aleppo, Beck, Bhargava, Bode, Carlson, Boehringer Ingelheim, the American Association of New York, New York: Robin Goland, MD (PI); Lauren
Chaytor, Fox, Goland, Hirsch, Kruger, Kudva, Levy, Clinical Endocrinologists, Mannkind, Culinary Golden, MD (I); Sarah Pollak, RN, MSN (PC);
McGill, Peters, Philipson, Philis-Tsimikas, Pop-Busui, Medicine, and the Jaeb Center for Health Research. Courtney Melrose, MPH, RDN, CDE (C); Analia
Shah, Vendrame, Verdejo, Weinstock. Dr Peters reported receipt of personal fees from Alvarez, RN, BSN (C); Elizabeth Robinson (C);
Statistical analysis: Kanapka, Fox. Medscape, Sanofi, Lexicon, Becton Dickinson, Eleanor Zagoren (C); University of North Carolina
Obtained funding: Pratley, Miller. Abbot Diabetes Care, Bigfoot, Mannkind, Novo Diabetes Care Center, Chapel Hill, North Carolina:
Administrative, technical, or material support: Nordisk, Lilly, and Boehringer Ingelheim; grants Laura Young, MD, PhD (PI); Elizabeth Harris, MD,
Rickels, Beck, Bode, Carlson, Chaytor, Goland, from AstraZeneca, vTv Therapeutics, Mannkind, FACE (I); John Buse, MD, PhD (I); Katherine
Philipson, Vendrame, Verdejo, Miller. and Dexcom; and stock options for Mellitus Health, Bergamo, BSN, MSN, FNP-C (I); Marian Sue
Supervision: Pratley, Rickels, Ahmann, Aleppo, Omada Health, Stability Health, Pendulum Kirkman, MD (I); Jean Dostou, MD, FACE (I);
Beck, Carlson, Chaytor, Goland, Hirsch, Kudva, Therapeutics, and Livongo. Dr Shah reported Alexander Kass, BSN, RN, CDE (PC); Milana Dezube,
Levy, Peters, Philipson, Vendrame, Weinstock, receipt of consulting fees through the University of BSN, RN, CDE (C); Rahul Kathard (C); Jamie C.
Miller. Colorado from Dexcom and grants from vTv Diner, BSN, RN, CDE (C); Henry Ford Health System,
Conflict of Interest Disclosures: Dr Pratley therapeutics, Novo Nordisk, Mylan GmbH, Sanofi Detroit, Michigan: Davida Kruger, NP (PI); Natalie
reported lecture and/or consultancy fees and/or US Services Inc, Insulet, and the NIH. Dr Weinstock Corker (PC); Heather Remtema (C); Keck School of
grants paid to his institution, AdventHealth, from reported receipt of grants from the Juvenile Medicine, University of Southern California, Los
AstraZeneca, Boehringer Ingelheim, Eisai Inc, Diabetes Research Foundation, Insulet Corporation, Angeles: Anne Peters, MD (PI); Mark Harmel, MPH,
GlaxoSmithKline, Glytec LLC, Janssen, Lexicon Tolerion Inc, Lilly, Medtronic, Diasome CDE (PC); SUNY Upstate Medical University,
Pharmaceuticals, Ligand Pharmaceuticals Inc, Lilly, Pharmaceuticals, Boehringer Ingelheim, Oramed Syracuse, New York: Ruth Weinstock, MD, PhD (PI);
Merck, Mundipharma, Novo Nordisk, Pfizer, Sanofi, Ltd, and Mylan GmbH and personal fees from Suzan Bzdick, RN, CDE (PC); Atlanta Diabetes
and Takeda; receipt of grants from Lexicon Insulogic. Dr Miller reported receipt of nonfinancial Associates, Atlanta, Georgia: Bruce Bode, MD (PI);
Pharmaceuticals, Ligand Pharmaceuticals Inc, Lilly, support from Dexcom and Tandem. No other Jennifer Boyd, PA (I); Joseph Johnson, PA (I); Lisa
Merck, Novo Nordisk, Sanofi, and Takeda; and disclosures were reported. Kiblinger, RN, NP-C, CDE (I); Jonathan Ownby, MD
receipt of personal fees from Sanofi US Services Inc. Funding/Support: This study was funded by JDRF (I); Nitin Rastogi, MBBS (PC); Blake Winslett (C);
Dr Rickels reported receipt of personal fees from and the Leona M. and Harry B. Helmsley Charitable Tracy Lawrence (C); Harold Schnitzer Diabetes
Hua Medicine, Xeris Pharmaceuticals, Semma Trust by a grant provided to the Jaeb Center for Health Center, Oregon Health and Science
Therapeutics, and Sernova; grants from Xeris Health Research. The National Center for Research University, Portland: Andrew Ahmann, MD (PI);
Pharmaceuticals; and nonfinancial support from Resources and the National Center for Advancing Jessica Castle, MD (I); Farahnaz Joarder, MD (I);
Merck & Co. Dr Ahmann reported contract research Translational Sciences of the NIH (grant Diana Aby-Daniel, PA (I); Victoria Morimoto, PA (I);
payments to his institution from Dexcom and UL1TR001878) support the Center for Human Kathryn Hanavan, RN, NP (I); Kristin Jahnke (PC);
receipt of personal fees from Medtronic. Dr Aleppo Phenomic Science at the University of Rebecca Fitch (C); Brianna Moralez-Gomez (C);
reported receipt of grants from Novo Nordisk, Pennsylvania. Dexcom provided study CGM devices Washington University, St Louis, Missouri: Janet
Dexcom, AstraZeneca, and Lilly and personal fees and sensors. McGill, MD (PI); Maamoun Salam, MD (I); Stacy
from Dexcom, Medtronic, Insulet, and Novo Hurst, RN, BSN, CDE (PC); Mary Jane Clifton, CCRP
Role of the Funders/Sponsors: JDRF, the Leona M. (C); Carol Recklein, RN, MHS, CDE (C); Toni
Nordisk. Dr Beck reported consulting fees paint to and Harry B. Helmsley Charitable Trust, and
his institution from Bigfoot Biomedical, Tandem Schweiger, RN (C); Alex Goay, BA (C); Northwestern
Dexcom were not involved in the design and University, Chicago, Illinois: Grazia Aleppo, MD (PI);
Diabetes Care, Insulet, and Lilly and receipt of conduct of the study; the collection, management,
grants from Dexcom and Tandem Diabetes Care Emily Szmuilowicz, MD (I); Elaine Massaro, MS, RN,
analysis, and interpretation of the data; or in writing CDE (PC); Anupam Bansal, MD (C); Division of
and nonfinancial support from Dexcom, Tandem the original manuscript draft or revision of the
Diabetes Care, Roche, and Ascensia. Dr Bhargava Endocrinology, Diabetes and Metabolism, University
manuscript. JDRF, the Leona M. and Harry B. of Miami, Miami, Florida: Francesco Vendrame, MD,
reported receipt of grants from Sanofi, Helmsley Charitable Trust, and Dexcom were sent
AstraZeneca, Lilly, United BioSource Corporation, PhD (PI); Natalia Sanders-Branca, MD (PC); Della
the manuscript for review, but any revisions made Matheson, RN, CDE (C); University of Michigan, Ann
Dexcom, Teijin America Inc, Bayer Healthcare based on their comments were at the discretion of
Pharmaceuticals, Boehringer Ingelheim, Arbor: Rodica Pop-Busui, MD, PhD (PI); Lynn Ang,
the authors, and permission for submitting content MD (I); Kara Mizokami-Stout, MD (I); Cynthia
Bristol-Meyers Squibb Research and Development, to the journal was not required. There was no
Gan & Lee Pharmaceutical, the Jaeb Center for Plunkett, RN (PC); Brittany Plunkett (C); Virginia
approval of JDRF, the Leona M. and Harry B. Leone (C); University of Pennsylvania Perelman
Health Research, KOWA Research Institute Inc, Helmsley Charitable Trust, or Dexcom required or
Medtronic MiniMed, Mylan GmbH, Novo Nordisk, School of Medicine/Rodebaugh Diabetes Center,
obtained for manuscript submission. Philadelphia: Michael Rickels, MD, MS (PI); Amy
AstraZeneca, Lilly, and Theracos Sub LLC; speaker
fees from Sanofi, AstraZeneca, and Lilly; and WISDM Study Group: Participating principal Peleckis, MSN, CRNP (I); Cornelia Dalton-Bakes, MS,
consultant fees from Sanofi. Dr Carlson reported investigators (PIs), coinvestigators (Is), primary CCRC (PC); Eileen Markmann, BSN (C); University of
receipt of grants from Novo Nordisk, Medtronic, coordinator (PCs), and coordinators (Cs) are listed Massachusetts Medical School, Worcester: Michael
Insulet, Sanofi, Dexcom, Abbott, Lilly, and below. All study personnel listed below were Thompson, MD (PI); Nina Rosano, MD (I); Celia
UnitedHealth; he reports contracts as a research involved in data collection. Additional roles beyond Hartigan, RN, MPH (PC); Iowa Diabetes and
investigator and/or consultant through his data collection are noted. Icahn School of Medicine Endocrinology Research Center, West Des Moines:
employer, HealthPartners Institute/International at Mt Sinai, New York, New York: Carol Levy, MD, Anuj Bhargava, MD (PI); Kathleen Fitzgerald, RN (I);
Diabetes Center at Park Nicollet (with no personal CDE (PI); David Lam, MD (I); Grenye O’Malley, MD Kirstie Stifel (PC); Lisa Borg (C); AdventHealth,
income received), with Novo Nordisk, Medtronic, (I); Camilla Levister, NP, CDE (I); Nirali Shah, MD (I); Translational Research Institute, Orlando, Florida:
Insulet, Sanofi, Abbott, Sensionics, and Lilly; in Selassie Ogyaadu, MD, MPH (PC); Mayo Clinic, Richard Pratley, MD (PI); Melissa Rooney, ARNP (I);
addition, Dr Carlson has a patent to US Provisional Rochester, Minnesota: Yogish Kudva, MD (PI); Heather Richmond, PA (I); Karthik Chivukula, MD
Patent Application Serial No. 62/443 004 pending. Vinaya Simha, MD (I); Shelly McCrady Spitzer (PC); (I); Keri Whitaker, RN (PC); Karla Flores Perez (C);
Dr Chaytor reported receipt of personal fees from Corey Reid (C); International Diabetes Center/Park University of Chicago, Chicago, Illinois: Louis
Lilly. Dr Kruger reported receipt of grants and Nicollet, Minneapolis, Minnesota: Anders Carlson, Phillipson, MD, PhD (PI); Celeste Thomas, MD, MS

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 Research Original Investigation Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes

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