Benefits of Continuous Glucose Monitoring With GEM Lifestyle Modification for Adults With Type 2 Diabetes
NCT ID: NCT03207893
Last Updated: 2021-02-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
24 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-07-19
Study Completion Date
2020-01-23
Brief Summary
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The purpose of this study is to determine if the use of continuous glucose monitoring with the GEM lifestyle modification program (Glycemic load, Exercise and Monitoring glucose) will result in better diabetes control than routine care.
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Detailed Description
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Type 2 diabetes (t2d) is a major epidemic of the developing world which has huge fiscal consequences and many physical complications. It is thought to be brought on in part by contemporary easy access to high energy foods and reduced physical activity, resulting in increased belly fat that culminates in growing insulin resistance and subsequent hyperglycemia. Because of ease and efficacy of medication management, t2d is primarily managed with ever-escalating medication use, which significantly contributes to medical cost and possibly the progression of the disease itself.
An effective supplement or alternative to medication management is lifestyle modification. Conventional lifestyle modification focuses on reducing body fat and insulin resistance through weight reduction from caloric restriction and aerobic exercise. Sustained routine application of this approach is limited because some individuals do not need to lose weight, some do not want to lose weight, others cannot lose weight, and when successful, lifelong weight reduction is difficult to sustain. A useful paradigm shift in lifestyle treatment of t2d might be to go from reducing calories to reducing postprandial glucose (PPG), the primary contributor to glycosylated hemoglobin (HbA1c).
PPG spikes can be prevented by replacing high with low glycemic load foods and dampened by engaging in postprandial physical activity. This is exemplified by the integrated Glycemic load, Exercise and Monitoring glucose (GEM) program. It promotes choices of low glycemic load foods and increased physical activity, directed by glucose monitoring feedback. Glucose feedback can: 1) educate people as to what food choices minimize PPG and what physical activity choices directly lower PPG, 2) activate individuals when glucose is out of their desired range by alerting them to make choices to lower high glucose or raise low glucose, and 3) motivate individuals to repeat those choices that resulted in desirable glucose consequences. The educating, activating and motivating benefits of glucose feedback are thought to be qualitatively and quantitatively enhanced through continuous glucose monitoring (CGM).
It is hypothesized that, compared to Routine Care (RC), GEM with CGM (GEM+CGM) administered to adults with t2d who are failing with oral medication management will result in better diabetes control (lower HbA1c), reduced medication management (less medication), and better psychological functioning (e.g. greater sense of empowerment) in the short term (3 month follow-up). Further, it is hypothesized that their reduction in HbA1c will be driven by a reduction in PPG.
An effective supplement or alternative to medication management is lifestyle modification. Conventional lifestyle modification focuses on reducing body fat and insulin resistance through weight reduction from caloric restriction and aerobic exercise. Sustained routine application of this approach is limited because some individuals do not need to lose weight, some do not want to lose weight, others cannot lose weight, and when successful, lifelong weight reduction is difficult to sustain. A useful paradigm shift in lifestyle treatment of t2d might be to go from reducing calories to reducing postprandial glucose (PPG), the primary contributor to glycosylated hemoglobin (HbA1c).
PPG spikes can be prevented by replacing high with low glycemic load foods and dampened by engaging in postprandial physical activity. This is exemplified by the integrated Glycemic load, Exercise and Monitoring glucose (GEM) program. It promotes choices of low glycemic load foods and increased physical activity, directed by glucose monitoring feedback. Glucose feedback can: 1) educate people as to what food choices minimize PPG and what physical activity choices directly lower PPG, 2) activate individuals when glucose is out of their desired range by alerting them to make choices to lower high glucose or raise low glucose, and 3) motivate individuals to repeat those choices that resulted in desirable glucose consequences. The educating, activating and motivating benefits of glucose feedback are thought to be qualitatively and quantitatively enhanced through continuous glucose monitoring (CGM).
It is hypothesized that, compared to Routine Care (RC), GEM with CGM (GEM+CGM) administered to adults with t2d who are failing with oral medication management will result in better diabetes control (lower HbA1c), reduced medication management (less medication), and better psychological functioning (e.g. greater sense of empowerment) in the short term (3 month follow-up). Further, it is hypothesized that their reduction in HbA1c will be driven by a reduction in PPG.
Conditions
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Diabetes Mellitus, Type 2
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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GEM+CGM
GEM lifestyle modification \& continuous glucose monitoring
Group Type
EXPERIMENTAL
GEM lifestyle modification & continuous glucose monitoring
Intervention Type
BEHAVIORAL
Four treatment sessions of GEM lifestyle modification in 3 months and continuous glucose monitoring during the first 14 days of each of the 3 months.
Routine Care
Intervention Type
OTHER
Subject's current t2d treatment
Routine Care
Subject's current t2d treatment
Group Type
ACTIVE_COMPARATOR
Routine Care
Intervention Type
OTHER
Subject's current t2d treatment
Interventions
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GEM lifestyle modification & continuous glucose monitoring
Four treatment sessions of GEM lifestyle modification in 3 months and continuous glucose monitoring during the first 14 days of each of the 3 months.
Intervention Type
BEHAVIORAL
Routine Care
Subject's current t2d treatment
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes
* Between the ages of 21 and 80
* Failed on an oral medication regimen (HbA1c \> 7.5%).
* Between the ages of 21 and 80
* Failed on an oral medication regimen (HbA1c \> 7.5%).
Exclusion Criteria
* Takes insulin
* Took medications in the last 3 months that impede weight loss (e.g., prednisone)
* Pregnant or contemplating pregnancy in the next 12 months
* Conditions that preclude increasing physical activity (e.g. severe neuropathy, cardiovascular disease, chronic obstructive pulmonary disease/emphysema, osteoarthritis, stroke)
* Severe mental disease (e.g. manic depressive illness, severe depression, or active substance abuse)
* Undergoing treatment for cancer
* History of lactic acidosis
* Marked renal impairment (eGFR \< 45; stage 3b chronic kidney disease)
* Takes psychotropic medications that raise blood glucose (e.g. atypical antipsychotics)
* Cannot read English.
* Took medications in the last 3 months that impede weight loss (e.g., prednisone)
* Pregnant or contemplating pregnancy in the next 12 months
* Conditions that preclude increasing physical activity (e.g. severe neuropathy, cardiovascular disease, chronic obstructive pulmonary disease/emphysema, osteoarthritis, stroke)
* Severe mental disease (e.g. manic depressive illness, severe depression, or active substance abuse)
* Undergoing treatment for cancer
* History of lactic acidosis
* Marked renal impairment (eGFR \< 45; stage 3b chronic kidney disease)
* Takes psychotropic medications that raise blood glucose (e.g. atypical antipsychotics)
* Cannot read English.
Minimum Eligible Age
21 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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DexCom, Inc.
INDUSTRY
Sponsor Role
collaborator
University of Virginia
OTHER
Sponsor Role
lead
Responsible Party
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Daniel Cox, PhD
Professor, Departments of Psychiatry, Internal Medicine and Ophthalmology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Daniel J Cox, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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University of Virginia, Dept. of Psychiatry and Neurobehavioral Sciences
Charlottesville, Virginia, United States
Site Status
Countries
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United States
References
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Reference Type
BACKGROUND
Rynders CA, Weltman JY, Jiang B, Breton M, Patrie J, Barrett EJ, Weltman A. Effects of exercise intensity on postprandial improvement in glucose disposal and insulin sensitivity in prediabetic adults. J Clin Endocrinol Metab. 2014 Jan;99(1):220-8. doi: 10.1210/jc.2013-2687. Epub 2013 Dec 20.
Reference Type
BACKGROUND
Bosi E, Scavini M, Ceriello A, Cucinotta D, Tiengo A, Marino R, Bonizzoni E, Giorgino F; PRISMA Study Group. Intensive structured self-monitoring of blood glucose and glycemic control in noninsulin-treated type 2 diabetes: the PRISMA randomized trial. Diabetes Care. 2013 Oct;36(10):2887-94. doi: 10.2337/dc13-0092. Epub 2013 Jun 4.
Reference Type
BACKGROUND
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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19313
Identifier Type: -
Identifier Source: org_study_id
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