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

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ClinicalTrials.gov Identifier: NCT03207893
Recruitment Status : Completed
First Posted : July 5, 2017
Last Update Posted : February 26, 2021
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
Daniel Cox, PhD, University of Virginia

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: GEM lifestyle modification & continuous glucose monitoring Other: Routine Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 19, 2018
Actual Primary Completion Date : January 23, 2020
Actual Study Completion Date : January 23, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207893


Locations
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United States, Virginia
University of Virginia, Dept. of Psychiatry and Neurobehavioral Sciences
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
DexCom, Inc.
Investigators
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Principal Investigator: Daniel J Cox, PhD University of Virginia
  Study Documents (Full-Text)

Documents provided by Daniel Cox, PhD, University of Virginia:
Informed Consent Form  [PDF] April 9, 2019

Additional Information:
Publications:

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Responsible Party: Daniel Cox, PhD, Professor, Departments of Psychiatry, Internal Medicine and Ophthalmology, University of Virginia
ClinicalTrials.gov Identifier: NCT03207893    
Other Study ID Numbers: 19313
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases