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

February 24, 2021 updated by: Daniel Cox, PhD, University of Virginia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia, Dept. of Psychiatry and Neurobehavioral Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GEM+CGM
GEM lifestyle modification & continuous glucose monitoring
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
Active Comparator: Routine Care
Subject's current t2d treatment
Other: Routine Care
Subject's current t2d treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: baseline, 3 months post-intervention
Change in HbA1c measured via blood test
baseline, 3 months post-intervention
Medication changes
Time Frame: baseline, 3 months post-intervention
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)
Time Frame: baseline, 3 months post-intervention
ASA24 survey across 3 separate days
baseline, 3 months post-intervention
change in food choices (energy bar selection)
Time Frame: baseline, 3 months post-intervention
At assessment visits, subjects will choose between energy bars that do or dont support the intervention principles.
baseline, 3 months post-intervention
Exercise (Fitbit)
Time Frame: baseline, 3 months post-intervention
daily activity will be recorded
baseline, 3 months post-intervention
change in psychological functioning (dietary habits questionnaire)
Time Frame: baseline, 3 months post-intervention
The Food Questionnaire
baseline, 3 months post-intervention
change in psychological functioning (quality of life questionnaire)
Time Frame: baseline, 3 months post-intervention
WHOQO-BREF Questionnaire
baseline, 3 months post-intervention
change in psychological functioning (depression questionnaire)
Time Frame: baseline, 3 months post-intervention
Patient Health Questionnaire (PHQ-9)
baseline, 3 months post-intervention
change in psychological functioning (numeracy questionnaire)
Time Frame: baseline, 3 months post-intervention
Numeracy Scale - measures how good one is with numbers
baseline, 3 months post-intervention
change in psychological functioning (diabetes knowledge questionnaire)
Time Frame: baseline, 3 months post-intervention
Diabetes Knowledge Scale - measures diabetes knowledge
baseline, 3 months post-intervention
change in psychological functioning (empowerment questionnaire)
Time Frame: baseline, 3 months post-intervention
Diabetes Empowerment Scale
baseline, 3 months post-intervention
Psychological functioning (PAID questionnaire)
Time Frame: baseline, 3 months post-intervention
Problem Area In Diabetes scale (PAID) - measures concerns about diabetes
baseline, 3 months post-intervention
change in psychological functioning (attitude towards glucose monitoring questionnaire)
Time Frame: baseline, 3 months post-intervention
The Glucose Monitoring Satisfaction Survey (GMSS)
baseline, 3 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

DexCom, Inc.

Investigators

  • Principal Investigator: Daniel J Cox, PhD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2018

Primary Completion (Actual)

January 23, 2020

Study Completion (Actual)

January 23, 2020

Study Registration Dates

First Submitted

October 28, 2016

First Submitted That Met QC Criteria

June 30, 2017

First Posted (Actual)

July 5, 2017

Study Record Updates

Last Update Posted (Actual)

February 26, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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