Benefits of Continuous Glucose Monitoring With GEM Lifestyle Modification for Adults With Type 2 Diabetes

Study Overview
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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.

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.

Official Title
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Benefits of Adding Continuous Glucose Monitoring to Glycemic Load, Exercise, and Monitoring of Blood Glucose (GEM) for Adults With Type 2 Diabetes - Phase 2

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: GEM lifestyle modification & continuous glucose monitoring
* Other: Routine Care


Participation Criteria
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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%). 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GEM+CGM<br>GEM lifestyle modification & continuous glucose monitoring | Behavioral: GEM lifestyle modification & continuous glucose monitoring<br>* 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.<br>Other: Routine Care<br>* Subject's current t2d treatment<br>|
| Active Comparator: Routine Care<br>Subject's current t2d treatment | Other: Routine Care<br>* Subject's current t2d treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Change in HbA1c measured via blood test | baseline, 3 months post-intervention | 
| Medication changes | Changes in prescribed medications (type and/or dosage) | baseline, 3 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in food choices (ASA24 survey) | ASA24 survey across 3 separate days | baseline, 3 months post-intervention | 
| change in food choices (energy bar selection) | At assessment visits, subjects will choose between energy bars that do or dont support the intervention principles. | baseline, 3 months post-intervention | 
| Exercise (Fitbit) | daily activity will be recorded | baseline, 3 months post-intervention | 
| change in psychological functioning (dietary habits questionnaire) | The Food Questionnaire | baseline, 3 months post-intervention | 
| change in psychological functioning (quality of life questionnaire) | WHOQO-BREF Questionnaire | baseline, 3 months post-intervention | 
| change in psychological functioning (depression questionnaire) | Patient Health Questionnaire (PHQ-9) | baseline, 3 months post-intervention | 
| change in psychological functioning (numeracy questionnaire) | Numeracy Scale - measures how good one is with numbers | baseline, 3 months post-intervention | 
| change in psychological functioning (diabetes knowledge questionnaire) | Diabetes Knowledge Scale - measures diabetes knowledge | baseline, 3 months post-intervention | 
| change in psychological functioning (empowerment questionnaire) | Diabetes Empowerment Scale | baseline, 3 months post-intervention | 
| Psychological functioning (PAID questionnaire) | Problem Area In Diabetes scale (PAID) - measures concerns about diabetes | baseline, 3 months post-intervention | 
| change in psychological functioning (attitude towards glucose monitoring questionnaire) | The Glucose Monitoring Satisfaction Survey (GMSS) | baseline, 3 months post-intervention |