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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03207893
• Other study ID #: 19313
• Status: Completed
• Phase: N/A
• Start date: July 19, 2018
• Est. completion date: January 23, 2020

Study information

• Verified date: February 2021
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 23, 2020
• Est. primary completion date: January 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• 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.

Other:
• Routine Care
Subject's current t2d treatment

Locations

Country	Name	City	State
United States	University of Virginia, Dept. of Psychiatry and Neurobehavioral Sciences	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	DexCom, Inc.

Country where clinical trial is conducted

United States, 

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* Note: There are 59 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Change in HbA1c measured via blood test	baseline, 3 months post-intervention
Primary	Medication changes	Changes in prescribed medications (type and/or dosage)	baseline, 3 months post-intervention
Secondary	change in food choices (ASA24 survey)	ASA24 survey across 3 separate days	baseline, 3 months post-intervention
Secondary	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
Secondary	Exercise (Fitbit)	daily activity will be recorded	baseline, 3 months post-intervention
Secondary	change in psychological functioning (dietary habits questionnaire)	The Food Questionnaire	baseline, 3 months post-intervention
Secondary	change in psychological functioning (quality of life questionnaire)	WHOQO-BREF Questionnaire	baseline, 3 months post-intervention
Secondary	change in psychological functioning (depression questionnaire)	Patient Health Questionnaire (PHQ-9)	baseline, 3 months post-intervention
Secondary	change in psychological functioning (numeracy questionnaire)	Numeracy Scale - measures how good one is with numbers	baseline, 3 months post-intervention
Secondary	change in psychological functioning (diabetes knowledge questionnaire)	Diabetes Knowledge Scale - measures diabetes knowledge	baseline, 3 months post-intervention
Secondary	change in psychological functioning (empowerment questionnaire)	Diabetes Empowerment Scale	baseline, 3 months post-intervention
Secondary	Psychological functioning (PAID questionnaire)	Problem Area In Diabetes scale (PAID) - measures concerns about diabetes	baseline, 3 months post-intervention
Secondary	change in psychological functioning (attitude towards glucose monitoring questionnaire)	The Glucose Monitoring Satisfaction Survey (GMSS)	baseline, 3 months post-intervention

External Links

•   American Diabetes Association (2012). Living with diabetes: Complications. Retrieved on 5/17/15