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Crimson Publishers Research Article

Wings to the Research

Meal Replacements in Conjunction


with an Integrated, Technology-Driven
ISSN: 2689-2707 Strategy for Treatment of Patients
with Diabetes in Rural, Underserved
Areas: A Pilot Study
Richard J Santen1*, Cindy Cunningham2, Carla Horton3, Ralf Nass1 and Wei
Yue1
1
Department of Medicine, Division of Endocrinology and Metabolism, USA
2
Martinsville Henry County Coalition for Health and Wellness, USA
3
Tri-Area Community Health Centers, USA

*Corresponding author: Richard J


Abstract
Santen MD, Division of Endocrinology and
Metabolism, University of Virginia Health Background: Rural, medically-underserved, financially-challenged geographical areas lack
System, Charlottesville, USA endocrinologists to provide consultation and management of patients with uncontrolled diabetes.
Our prior studies in 139 patients with diabetes attending rural, Federally Qualified Community Health
Submission: March 09, 2023 Centers, demonstrated the utility of telemedicine to link patients with endocrinologists and markedly
Published: March 21, 2023 improve glycemic control. However, a critical limitation was the inability to achieve weight reductions,
even with nutritional education.
Volume 4 - Issue 1
Study Design: This pilot study utilized meal replacements linked to an integrated, technology-driven
strategy for management of patients with uncontrolled diabetes in underserved areas. Primary and
How to cite this article: Richard J
Santen*, Cindy Cunningham, Carla Horton, secondary goals: Our primary goal was weight reduction and secondarily, improved glucose control.
Ralf Nass and Wei Yue. Meal Replacements Result: Eleven patients completed 3 months of the program and 7, the entire 6 months. In the 11 patients
in Conjunction with an Integrated, evaluated at three months, body weights dropped from 271±16 to 252±11 (SEM) pounds (P=0.002). The
Technology-Driven Strategy for Treatment
meal replacement diet was associated with a decrease in insulin requirements with doses falling from
of Patients with Diabetes in Rural,
Underserved Areas: A Pilot Study. Trends 221±41 to 129±23 (SEM) units daily (P=0.004). Hemoglobin A1c levels declined from 9.85±0.33% to
Telemed E-Health. 4(1). TTEH. 000578. 7.93±0.31% (SEM) (p=0.001). In the 7 patients completing the entire 6 months of the protocol, similar
2023. reductions persisted. Mean compliance with meal replacements on a scale of 0 to 10 ranged downward
DOI: 10.31031/TTEH.2023.04.000578 from 8.6 to 7.6 (P=NS) with increasing duration of study.
Conclusion: The study was unique in tailoring a program specifically to rural, underserved areas and
Copyright@ Richard J Santen, This
demonstrated weight, insulin dose, and HbA1c reductions. The data now require confirmation of the use
article is distributed under the terms of
the Creative Commons Attribution 4.0 of meal replacements linked to multiple technologies in a future, randomized trial.
International License, which permits Keywords: Nutrisystem®D® meal replacement; Glucommander-outpatient; Telcare meter;
unrestricted use and redistribution telemedicine; Remote consultation; Federally qualified community health centers
provided that the original author and
source are credited. Abbreviations: CDCES: Certified Diabetes Care and Education Specialists

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].

Trends in Telemedicine & E-health 1


TTEH.000578. 4(1).2023 2

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].

Figure 1: Characteristics of federally qualified community health centers.

Trends Telemed E-Health Copyright © Richard J Santen


TTEH.000578. 4(1).2023 3

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).

Table 1: Inclusion and exclusion criteria for the study.

Persistently poorly controlled diabetes mellitus , type 2, requirement for insulin


Ages 18-75 , male and female
Inclusion Criteria Renal function of an eGFR of 45 or above
Patient competent to use Telcare meter and DEXCOM G6 Continuous Glucose Monitoring system (CGM)
HbA1C continuously >8.0% for > 6 months with at least two HbA1C values
Active alcohol/substance abuse
Active cancer therapy
HIV/AIDS
Organ transplant
Cirrhosis of liver
Hearing , speech or cognitive impairment
Dementia or psychosis
Exclusion Criteria Inability to speak English or interact effectively with interpreter
Life threatening illness
Recent cardiovascular event or stroke
Prior hypoglycemic seizure or come
Refusal to perform self-monitoring of glucose
Use of subcutaneous glucose pump
>75 years of age of age <18
Nursing home or extended facility resident

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.

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TTEH.000578. 4(1).2023 4

Figure 2: Example of the data provided in the glucommander-outpatient dashboard.

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

Trends Telemed E-Health Copyright © Richard J Santen


TTEH.000578. 4(1).2023 5

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.

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TTEH.000578. 4(1).2023 6

losses as in this study [35,42]. Admittedly, a separate research trial


would be required to more directly determine the specific effects
of the Nutrisystem®D® diet independently of the technological
components we utilized here. We recognize that it would not
be practical to utilize these meal replacement diets on a long-
term basis. Their utility, in our opinion, is to provide an ideal
method of education about portion sizes, the role of snacks and
the composition of diets. As our patients had uniformly obtained
nutrition education sessions previously, we tentatively concluded
that the Nutrisystem®D® approach is a more effective means of
education.

It was expected that patients would be variably compliant in


adhering to the Nutrisystem®D® diets. A subjective scoring system
confirmed this supposition as the degree of compliance among
patients and by the same patient (Figure 4) was variable. Patients
commented that the food was good tasting but became somewhat
repetitive over time. This could have reduced compliance as the
duration of the study progressed. The data suggested but did not
statistically confirm that the degree of compliance did diminish
during the later months of the protocol. Based on this concept, we
speculate that a 3-month use of the Nutrisystem®D® diet might be
Figure 4: Example in one patient of level of compliance, sufficient for patient education and the weight loss observed at that
body weight, average glucose, an insulin dose over the time period [35,42].
duration of the protocol.
One key to the success of our prior and the current program
Discussion appeared to be the interaction with patients on a weekly basis
[43]. This facilitated rapid changes in insulin dosage with resultant
This pilot study was designed to test whether a commercial
improvement in glucose levels which appeared to motivate patients.
meal replacement system, in conjunction with several technologic
While this pilot study utilized board certified endocrinologists, the
strategies, could result in weight loss. Notably, weight reduction
use of the glucommander-outpatient system could easily be used
was not accomplished in our previous five year study using
by nurses or pharmacists as no changes were made in the insulin
telemedicine to manage patients with diabetes in rural, financially
doses suggested by the glucommander-outpatient algorithm. For
challenged, underserved areas [30]. Our prior published study,
practical implementation of a program such as the one described,
involving 139 patients, demonstrated substantial improvement in
non-physician health care workers will likely be necessary to
glycemic control but importantly, no statistically significant weight
manage weekly phone calls [43].
loss. Accordingly, we designed this pilot trial which introduced meal
replacements and multiple telehealth technologies to facilitate the Some of the benefits of the program occurred before the six
effective management of this population of patients by academically month, planned termination date. For that and other reasons only
based endocrinologists. Our primary goal was to reduce body 7 of the 11 patients entering the study completed it. One patient
weight and secondarily, HbA1C levels. The combination of meal achieved excellent glycemic control within three months and did
replacements and the additional 5 technological components not see the benefit of continuing. Another decided to undergo
resulted in meeting our goal of statistically significant reductions bariatric surgery and a third could not adequately learn how to use
in weight loss, insulin dosages and HbA1C levels (Figure 3). Taken the telcare meter and DEXCOM CGM. A fourth was lost to follow up
together, these methods allowed achievement of important biologic for unknown reasons.
effects as documented by the marked reduction in insulin dosages
Our previously published program utilized a partially retired
and HbA1c levels.
endocrinologist (RJS). From this experience, we hypothesized that
While not proven, it is likely that the Nutrisystem®D® retired endocrinologists could be enlisted to re-enter practice
diets contributed substantially to the reduction in body weights and help to improve the work force gap which exists regarding
observed (Figure 3). This contention is based on the comparison trained endocrinologist to manage patients with diabetes.
of the current results using meal replacements where weight Termed “rebooting the endocrinologist”, a program utilizing such
reduction occurred and data in our prior study where weights individuals could also utilize a program such as that described here
remained stable. Additional support for this conclusion comes [30,44]. The template provided by this study could then be widely
from two published studies with prior use of the Nutrisystem®D® applied, particularly for Federally Qualified Health Centers in rural,
program in patients with diabetes which resulted in similar weight underserved financially challenged areas.

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TTEH.000578. 4(1).2023 7

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