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Completed

NCT Number: NCT03207893

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

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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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia, Dept. of Psychiatry and Neurobehavioral Sciences

Charlottesville, Virginia, 22908, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GEM lifestyle modification & continuous glucose monitoring

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

Other

Subject's current t2d treatment

Primary outcomes

  1. HbA1c

    Time frame: baseline, 3 months post-intervention

    Change in HbA1c measured via blood test

  2. Medication changes

    Time frame: baseline, 3 months post-intervention

    Changes in prescribed medications (type and/or dosage)

Secondary outcomes

  1. change in food choices (ASA24 survey)

    Time frame: baseline, 3 months post-intervention

    ASA24 survey across 3 separate days

  2. 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.

  3. Exercise (Fitbit)

    Time frame: baseline, 3 months post-intervention

    daily activity will be recorded

  4. change in psychological functioning (dietary habits questionnaire)

    Time frame: baseline, 3 months post-intervention

    The Food Questionnaire

  5. change in psychological functioning (quality of life questionnaire)

    Time frame: baseline, 3 months post-intervention

    WHOQO-BREF Questionnaire

  6. change in psychological functioning (depression questionnaire)

    Time frame: baseline, 3 months post-intervention

    Patient Health Questionnaire (PHQ-9)

  7. change in psychological functioning (numeracy questionnaire)

    Time frame: baseline, 3 months post-intervention

    Numeracy Scale - measures how good one is with numbers

  8. change in psychological functioning (diabetes knowledge questionnaire)

    Time frame: baseline, 3 months post-intervention

    Diabetes Knowledge Scale - measures diabetes knowledge

  9. change in psychological functioning (empowerment questionnaire)

    Time frame: baseline, 3 months post-intervention

    Diabetes Empowerment Scale

  10. Psychological functioning (PAID questionnaire)

    Time frame: baseline, 3 months post-intervention

    Problem Area In Diabetes scale (PAID) - measures concerns about diabetes

  11. change in psychological functioning (attitude towards glucose monitoring questionnaire)

    Time frame: baseline, 3 months post-intervention

    The Glucose Monitoring Satisfaction Survey (GMSS)

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • DexCom, Inc.

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 5, 2017
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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