Tteh 000578
Tteh 000578
Tteh 000578
Introduction
Patients with diabetes mellitus living in rural, economically challenged, medically
underserved areas generally lack endocrinologists for consultative evaluation and management
[1]. This deficiency of specialists has resulted primarily from a marked workforce gap of
endocrinologists in the United States which is particularly evident in underserved, rural areas
[2,3]. Multiple social, economic, educational, geographical, and transportation challenges are
involved in the treatment of patients in these rural areas as extensively reviewed previously
[1,4-11]. Telehealth has been used as a means to improve the care of patients with diabetes in
general as well those living in rural areas. [6,7,10,12-29].
Over the past five years, our team has attempted to overcome for it by our institutional review board. Six key elements of the
this gap in five rural clinics by means of telehealth, frequent technology included:
phone encounters, and educational sessions coordinated by
A. Nutrisystem®D® meal replacements as a means to
two academic endocrinologists [30]. Our comprehensive team
educate about calorie intake and meal composition
included endocrinologists, Certified Diabetes Care and Education
Specialist (CDCES), nutritionists, nurse practitioners, physicians B. The glucommander-outpatient algorithmic system to
and administrative staff at the participating clinics. Our program determine insulin dosages
provided comprehensive management of patients with diabetes
C. Telcare meters, weight scales, and BP cuffs to store
attending Federally Qualified Community Health Centers and was
glucose, weight and blood pressure data and upload to the
successful in reducing HbA1C levels. Weekly phone calls with
cloud
insulin instructions were considered important for gaining patient
compliance. Importantly, however, mean body weights did not D. DEXCOM continuous glucose monitoring to ensure
decrease [30]. As a recent emphasis in diabetes care has been on safety and lack of hypoglycemia at the start of use of meal
weight reduction as a primary goal, we recognized the need to replacements
design and implement additional measures to achieve this endpoint
E. iPads containing four 2 hour educational sessions
[31-33].
F. A cloud based movie describing the program to provide
Based on our prior experience with telemedicine and technology,
the specific details of each step to patients.
we designed a pilot program to enhance the ability of patients to
lose weight and achieve improved glucose control. We postulated We report here that this series of applicable technologies
that utilization of meal replacements with restricted calories would proved beneficial in the management of patients. Body weight,
facilitate weight loss and provide an excellent method to educate HbA1c levels and insulin doses fell statistically significantly at 3 and
patients about caloric content and portion control [34-38]. We also 6 months compared to baseline and without substantial incidence
utilized specific technologic approaches enabling us to work around of hypoglycemia. The data suggested the potential utility of this
several problems unique to rural areas encountered in our prior technology-driven program and provided sufficient data to support
study. Specifically, as internet access is limited in the rural areas initiating a large randomized trial in the future. The goal would
served, we devised a method of overcoming this problem by use of be to determine whether the approach used would be superior to
Telcare glucose meters [39] which store data and upload it when usual care in treating patient with diabetes in rural underserved
the patients drive their vehicles within the range of cell towers. The areas.
Telcare program also utilizes electronically enabled blood pressure Methods
cuffs and scales which allow transfer of data to the cloud [30].
Clinics: Federally Qualified Community Health Centers
The study design took into account the fact that the time provided the source of patients, financial support for critical
commitment needed to make weekly decisions about insulin personnel involved in the program, and for infrastructure (Figure
adjustments could be limiting. We hypothesized that the 1). Two separate organizational structures were utilized (1) The
glucommander- outpatient system would allow use of algorithms Tri-Area Community Health Center Program involved clinics at
to determine insulin doses and ultimately could be employed by Laurel Fork, Ferrum and Floyd, Virginia and (2) The Henry County
non-specialized providers, nurses or pharmacists [40,41]. For this Coalition for Health and Wellness included clinics at Bassett and
reason, we utilized this system to make effective recommendations Ridgeway, Virginia. As reported previously, these clinics are located
about insulin dosing. Employing each of these components, we in rural, underserved areas where the median family income is well
wrote up a detailed research protocol and obtained approval below the average for the Commonwealth of Virginia [30].
Patients: Individuals with type 2 diabetes who met the volunteer for the study. These included 7 women and four men with
inclusion and exclusion criteria listed in Table 1 were asked to a mean age of 59 (range 42 to 73).
Evaluations: Prior to the initial one hour telemedicine The four topics included:
evaluation, comprehensive records were sent electronically to the
A. The basics of diabetes.
two endocrinologist-co-authors (RJS and RN). The telemedicine
evaluation visits took place prior to initiation of the study and B. Nutrition basics.
utilized a standard form to obtain a comprehensive history. Vital
C. Diabetes self-management skills.
signs, demographic and lifestyle information were obtained by co-
authors (CC and CH) who were CDCESs (Certified Diabetes Care and D. Healthy eating lifestyle changes.
Education Specialists). The physical exam data were taken from
Telcare process: This data collection system uploaded
the records of exams performed by the primary care providers.
finger stick glucose measurements, blood pressure results, and
Laboratory data from prior clinic visits were at that time reviewed.
body weights into the Telcare meter. When the patient had either
A detailed consult report was then dictated, reviewed, and sent
immediate access to the internet or drove their vehicle within range
to the primary care provider. Data in the report included history,
of a cell tower while carrying the meter, the data were uploaded
physical exam, assessment, recommendations and the specific
to the cloud. The Telcare data were available to the investigators
laboratory tests requested.
by accessing the cloud based web site. In order for access to
Laboratory data: Prior to study entry and at three and six the algorithm for insulin dosage decisions, glucose data were
months, blood was obtained for HbA1C, comprehensive metabolic transferred electronically to the Glytec based glucommander–
panel, lipid profile, TSH, and CBC. Initial education for technology outpatient website. Blood pressures and body weights were not
use: The patients were taught by the co-authors, CC and CH, in the transferred but were accessed on the Telcare web site.
clinic to use the Telcare meter, blood pressure cuff and electronic
Glucommander-outpatient process: The Glytec web site
scales as well as the process that the system used to transfer that
displayed the recent average and time dependent glucose levels
data to the cloud.
and suggested insulin doses. The system allowed overrides and
Follow-up diabetes and nutrition educational sessions: mechanisms to alter suggested doses. The investigators accessed
Four, two hour educational sessions were provided to the patients these data weekly and called patients on the telephone to make
which were uploaded on to Apple iPADs as developed by the UVA recommendations (Figure 2).
nutrition team and supervised by a nutritionist.
Nutrisystem®D® Meal Replacements: The patients provided information about the percentage of very low and low
selected the food that they wished to eat and communicated this glucose values during these times of the study.
to Nutrisystem Inc, for construction of the Nutrisystem®D®
Compliance data: At the weekly phone calls, the patients were
diets. These consisted of an average of 1450 to 1550 calories per
asked to assess the degree of compliance subjectively, using a scale
day for men and 1200 to 1250 calories per day for women. The
of 0 to 10 with 10 representing complete compliance.
Nutrisystem®D® plan includes Nutrisystem®D® breakfasts,
lunches, dinners and snacks-2 snacks for male plans and 1 snack for Communications: The two CDCESs participating in the study
female plans. Using guidelines from Nutrisystem®D® instructions, (CC and CH) discussed the changes in insulin doses with the
patients supplement their Nutrisystem®D® food with fresh referring primary care providers who then ordered the insulin
grocery food add-ins to complete the daily meal plan. The full prescriptions as requested. The patients were called by telephone
composition of these diets for men and women is shown on Table 2. once weekly to review the glucomander-outpatient data and make
the changes in insulin dosage recommended by the glucommander-
Table 2: Composition of the meal replacement diets.
outpatient algorithm.
Men’s Plan Women’s Plan
Protocol approval: The study was approved by the University
Calories ~1450-1500 ~120-1250
of Virginia Institutional Review Board and written informed consent
Carbohydrates, %
45-55% 45-55% was obtained from all subjects. An IRB approved movie explaining
Calories
all of the procedures was shown to each potential subject prior to
(Grams) (163-206) (135-173)
obtaining informed consent.
Protein, % Calories 20-30% 20-30%
(Grams) (73-113) (60-94)
Result
Total Fat, % Calories ≤30% ≤30% In planning this study, we anticipated that the marked
(Grams) (≤50) (≤42) reduction in calories engendered by the Nutrisystem®D® diet
would cause an acute, potentially dangerous reduction in glucose
Saturated Fat, %
≤10% ≤10% levels. Accordingly, we utilized the DEXCOM Pro continuous glucose
Calories
(Grams) (≤17) (≤14) monitoring system during the first ten days of the study to identify
hypoglycemic episodes. In the first patient, the hourly glucose levels
Fiber (g) 30-40 25-35
monitored closely fell rapidly from 220 to 85mg% on the first day of
Sodium (mg) ≤2,300 ≤2,300
the study. In response, the insulin dose was reduced by 50% from
Added Sugar, % baseline values in this patient and then routinely in all subsequent
≤10% ≤10%
Calories
participants at the start of the Nutrisystem®D® diet. With this
(Grams) (≤25) (≤25)
adjustment, during the first ten days on the diet, episodes of very
Cholesterol (mg) ≤200 ≤200 low glucose levels (i.e <54mg %) occurred in only two patients (0.7
Safety measures: The patients utilized a DEXCOM Pro for 10 and 1.6 percent of measurements) and low values (i.e 54-69mg %)
days at the start of the study and again at 3 and 6 months. These in 5 patients (3.3, 1.4, 1.3, 3.7 and 4.8% of measurements). These
hypoglycemic episodes were correctly quickly with oral glucose with no exceptions. At each week’s phone call, the glucommander-
supplementation. outpatient logs were reviewed on line see example in Figure 2.
The data illustrate the individual glucose values, the average blood
The goal of statistically significant weight loss was achieved.
glucose levels, the glucose levels before breakfast, lunch, dinner
In the 11 patients evaluated at three months as body weights
and bedtime and the suggested insulin doses to be administered
dropped 7.1% from 271±16 to 252±11 (SEM) pounds (P=0.002)
as shown. The meal replacement diet and associated weight loss
and persisted in the 7 patients completing the study (245±20)
were reflected by a chronic drop in insulin requirements with doses
(SEM) pounds. (P=0.009) (Figure 3). During the entire course of the
falling 42% from 221±41 at baseline to 129±23 (SEM) units daily
study, insulin doses were given precisely according to the algorithm
(P=0.004) at three months and persisting at 6 months (Figure 3).
Figure 3: Data from the baseline and at three and six months in the subjects entered into the study.
Following the weekly insulin recommendations, as shown in and 142±17 (SEM) at 6 months. Similar comparisons for HDL
Figure 2, the baseline hemoglobin A1C levels fell significantly. In cholesterol were 38.8±4.0 versus 36±2.7 (SEM); for LDL-cholesterol
the 11 patients completing the three month protocol, the HbA1C 80.8±13 versus 75.6±14 (SEM); and for triglyceride 208±21 versus
decreased from 9.85±0.33% at baseline to 7.93±0.31% (SEM) 18±29 (SEM) with all P values non-statistically significant. Blood
(P=0.004). In those completing the entire six months, the levels pressure levels also did not change significantly averaging 154/89
dropped from 9.60±0.49% at baseline to 7.77±0.47% (SEM) at baseline and 152/86 at 6 months in the 7 patients completing
(P=0.004). Hypoglycemia at very low levels occurred in no patients the protocol.
at three months as detected by Dexcom and low values occurred
Compliance was highly variable and appeared likely to influence
in only one patient in 0.1% of measurements. At six months, no
both body weight and insulin levels. Mean levels of compliance
patients had very low values and one had low values on 1.4% of the
during weeks 1-4, 5-12, 13-20, and 21-24 were respectively 8.85,
measurements.
8.61, 7.66, an 8.0. Figure 4 provides anecdotal data in a single
Lipid levels did not changes significantly when comparing patient to illustrate how variations in compliance can affect insulin
baseline with 6 months. Total cholesterol was 150±17 at baseline levels and body weight.
In conclusion, while this pilot study involved relatively few 8. Barnett ML, Huskamp HA, Busch AB, Uscher-Pines L, Chaiyachati KH,
patients, the reductions in weight, insulin dosage and HbA1c et al. (2021) Trends in outpatient telemedicine utilization among rural
medicare beneficiaries, 2010 to 2019. JAMA health forum 2(10): 213282.
levels were highly statistically significant. We provided substantial
9. Gutierrez C (2020) Improving the care of students with diabetes in
evidence that meal replacements and use of multiple technological rural schools utilizing an online diabetes education program for school
methods can be used to improve the care of patients with diabetes, personnel. Rural and Remote Health 20(1): 5596.
living in rural underserved areas. This concept now requires 10. Marsh Z, Nguyen Y, Teegala Y, Cotter VT (2021) Diabetes management
confirmation in a large, randomized, controlled trial to determine among underserved older adults through telemedicine and community
if this approach is superior to usual care. health workers. Journal of the American Association of Nurse
Practitioners 34(1): 26-31.
Program Funding 11. Zachrison KS, Richard JV, Mehrotra A (2021) Paying for telemedicine in
smaller rural hospitals: Extending the technology to those who benefit
Funds for this pilot program were obtained from the University most. JAMA Health Forum 2(8): 211570.
of Virginia Center for Diabetes Technology, a grant from the 12. Daniel HB, Sulmasy LSJ(2015) Policy recommendations to guide the
School of Architecture Main Street program, and the Department use of telemedicine in primary care settings: An American college of
of Medicine. Nutrisystem®D® provided the Nutrisystem®D® physicians position paper. Annals of Internal Medicine 163(10): 787-
789.
program at a reduced cost as stipulated by a research contract
signed with that company. The Glytec company, who coordinated 13. Wakefield BJ, Koopman RJ, Keplinger LE, Bomar M, Bernt B, et al. (2014)
Effect of home telemonitoring on glycemic and blood pressure control
the glucommander outpatient program, received a lump sum in primary care clinic patients with diabetes. Telemedicine Journal &
for their participation which included an extensive educational E-Health 20(3): 199-205.
program and troubleshooting. 14. Karhula T, Vuorinen AL, Raapysjarvi K, Pakanen M, Itkonen P, et al.
(2015) Telemonitoring and mobile phone-based health coaching among
Acknowledgements finnish diabetic and heart disease patients: Randomized controlled trial.
Journal of Medical Internet Research 17(6): 153.
John Clarke from Glyctec provided invaluable advice about
15. Klonoff DC (2009) Using telemedicine to improve outcomes in diabetes
the utilization of the glycommander-outpatient program.
an emerging technology. Journal of Diabetes Science & Technology 3(4):
Myron Talbert from BioTelcare provided timely assistance in 624-628.
troubleshooting access problems and interpreting the dashboard 16. Klonoff DC (2015) Telemedicine for diabetes: Current and future trends.
data presentations. The providers at each of the Federally Funded Journal of Diabetes Science & Technology 10(1) 3-5.
Community Health Centers interacted very effectively with the 17. Klonoff DC (2016) Telemedicine for diabetes: Economic considerations.
protocol team and their help and cooperative is greatly appreciated. Journal of Diabetes Science & Technology 10(2): 251-253.
Harry Mitchell, Mary Oliveri, and Christian Wakeman coordinated 18. Cengiz E (2013) Analysis of a remote system to closely monitor
support from the Center for Diabetes Technology. Dr. Andy Basu glycemia and insulin pump delivery--is this the beginning of a wireless
transformation in diabetes management? Journal of Diabetes Science &
provided valuable advising in setting up the program and assessing Technology 7(2): 362-364.
results. The providers and administrative staff at the Federally 19. Bashshur RL, Shannon GW, Smith BR, Woodward MA (2015) The
Qualified Community Health Center clinics assisted all aspects of empirical evidence for the telemedicine intervention in diabetes
the study and were indispensable in its ruinning. management. Telemedicine Journal & E-Health 21(5): 321-354.
20. Zhai YkP, Zhu WjM, Cai YlP, Sun DxB, Zhao JP (2014) Clinical- and cost-
References effectiveness of telemedicine in type 2 diabetes mellitus: A systematic
1. Ross S, Benavides-Vaello, Schumann LP, Haberman M (2015) Issues that review and meta-analysis. Medicine 93(28): 312.
impact type-2 diabetes self-management in rural communities. Journal
21. Aikens JE, Zivin K, Trivedi R, Piette JD (2014) Diabetes self-management
of the American Association of Nurse Practitioners 27(11): 653-660.
support using mHealth and enhanced informal caregiving. Journal of
2. Vigersky RA, Fish L, Hogan P, Stewart A, Kutler S, et al. (2014) The Diabetes & its Complications 28(2): 171-176.
clinical endocrinology workforce: Current status and future projections
22. Deborah AG, Heather MY, Charlene CQ (2014) Telehealth remote
of supply and demand. Journal of Clinical Endocrinology & Metabolism
monitoring. Journal of Diabetes Science and Technology 8(2): 378-89.
99(9): 3112-3121.
23. Greenwood DA, Young HM, Quinn CC (2014) Telehealth remote
3. Rizza RA. (2003) A model to determine workforce needs for
monitoring systematic review: Structured self-monitoring of blood
endocrinologists in the United States until 2020. J Clin Endocrinol Metab
glucose and impact on A1C. Journal of Diabetes Science & Technology
88(5): 1979-1987.
8(2): 378-389.
4. Bell RA, Quandt SA, Arcury TA, Snively BM, Stafford JM, et al. (2005)
24. Franc S, Daoudi A, Mounier S, Boucherie B, Dardari D, et al. (2011)
Primary and specialty medical care among ethnically diverse, older rural
Telemedicine and diabetes: Achievements and prospects. Diabetes &
adults with type 2 diabetes: The ELDER Diabetes Study. Journal of Rural
Metabolism 37(6): 463-476.
Health 21(3): 198-205.
25. Massey CN, Appel BK, Cherrington AL (2010) Improving diabetes care
5. Theresa Capriotti, Tiffany Pearson (2020) Health Disparities in Rural
in ruarl communities: An overview of current initiatives and a call for
America: Current Challenges and Furutree Solutions Psychiatry Advisor.
renewed efforts. Clinical Diabetes 28: 20-27.
6. Crowley MJ, Edelman D, McAndrew AT, Kistler S, Danus S, et al. (2016)
26. Strawbridge LM, Lloyd JT, Meadow A, Riley GF, Howell BL (2015) Use
Practical telemedicine for veterans with persistently poor diabetes
of medicare’s diabetes self-management training benefit. Health Educ
control: A randomized pilot trial. Telemedicine Journal & E-Health
Behav 42(4): 530-538.
22(5): 376-384.
27. Mehrotra AJA, Busch AD, Souza J, Uscher-Pines L , Landon BE (2016)
7. Nyenwe EA, Ashby S, Tidwell J, Nouer SS, Kitabchi AE (2013) Improving
Utilization of telemedicine among rural medicare benificiaries. JAMA
diabetes care via telemedicine: lessons from the Addressing Diabetes in
315(18): 2015-2016.
Tennessee (ADT) project. Diabetes Care 34(3): 34.
28. Crossen S, Raymond J, Neinstein A (2020) Top 10 Tips for successfully 37. Cheskin LJ, Mitchell AM, Jhaveri AD, Mitola AH, Davis LM, et al. (2008)
implementing a diabetes telehealth program. Diabetes Technology & Efficacy of meal replacements versus a standard food-based diet for
Therapeutics 22(12): 920-928. weight loss in type 2 diabetes: A controlled clinical trial. Diabetes
Educator 34(1): 118-127.
29. Quinton JK, Ong MK, Sarkisian C, Casillas A, Vangala S, et al. (2022) The
Impact of Telemedicine on quality of care for patients with diabetes after 38. Noronha JC, Nishi SK, Braunstein CR, Khan TA, Blanco Mejia S, et al.
March 2020. Journal of general internal medicine 37(5): 1198-1203. (2019) The effect of liquid meal replacements on cardiometabolic
risk factors in overweight/obese individuals with type 2 diabetes: A
30. Santen RJ, Nass R, Cunningham C, Horton C, Yue W (2023) Intensive,
systematic review and meta-analysis of randomized controlled trials.
telemedicine-based, self-management program for rural, underserved
Diabetes Care 42(5): 767-776.
patients with diabetes mellitus: Re-entry of retired endocrinologists
into practice. Journal of Telemedicine & Telecare 29(2): 153-161. 39. (2015) Telcare: sophisticated technology with a personal appraoch.
31. Churuangsuk C, Hall J, Reynolds A, Griffin SJ, Combet E, et al. (2022) Diets 40. Bruce Bode, John Clarke (2017) Glucomander outpatient, a cloud-based
for weight management in adults with type 2 diabetes: An umbrella management solution, titrated patients to goal in 11 days and sustianed
review of published meta-analyses and systematic review of trials of a 2.6% dron in HbA1C over 6 months. International Conference on
diets for diabetes remission. Diabetologia 65(1): 14-36. Advanced Technologies & Treatments for Diabetes, USA.
32. Kimberly BB (2022) T2D weight management or glycemic control: The 41. Bode B, Clarke JG, Johnson J (2018) Use of decision support software to
debate continues. titrate multiple daily injections yielded sustained A1c reductions after 1
year. Journal of diabetes science and technology 12(1): 124-128.
33. Lingway I MJ (2022) Experts debate obesity vs glycemic control as
primary target for treating type 2 diabetes. Healio. 42. Foster GD, Borradaile KE, Vander Veur SS, Leh Shantz K, Dilks RJ, et al.
(2009) The effects of a commercially available weight loss program
34. Astbury NM, Piernas C, Hartmann-Boyce J, Lapworth S, Aveyard P, et al.
among obese patients with type 2 diabetes: A randomized study.
(2019) A systematic review and meta-analysis of the effectiveness of
Postgraduate medicine 121(5): 113-118.
meal replacements for weight loss. Obes Rev 20(4): 569-587.
43. Moreira AM, Marobin R, Escott GM, Rados DV, Silveiro SP (2022)
35. Foster GD, Wadden TA, Lagrotte CA, Vander Veur SS, Hesson LA, et al.
Telephone calls and glycemic control in type 2 diabetes: A PRISMA-
(2013) A randomized comparison of a commercially available portion-
compliant systematic review and meta-analysis of randomized clinical
controlled weight-loss intervention with a diabetes self-management
trials. Journal of telemedicine and telecare: 1357.
education program. Nutr Diabetes 3(3): 63.
44. Santen RJ (2020)”Re-booting” after retirement: Novel approach using
36. Kempf K, Rohling M, Niedermeier K, Gartner B, Martin S (2018)
telemedicine to solve the work-force gap in diabetes management.
Individualized meal replacement therapy improves clinically relevant
Maturitas 133: 68-69.
long-term glycemic control in poorly controlled type 2 diabetes patients.
Nutrients 10(8): 1022.