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

NCT03207893 | Completed

• 1 other identifier: 19313
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• change in food choices (ASA24 survey)

  baseline, 3 months post-intervention

• change in food choices (energy bar selection)

  baseline, 3 months post-intervention

• Exercise (Fitbit)

  baseline, 3 months post-intervention

• change in psychological functioning (dietary habits questionnaire)

  baseline, 3 months post-intervention

• change in psychological functioning (quality of life questionnaire)

  baseline, 3 months post-intervention

Study Arms (2)

GEM+CGM

EXPERIMENTAL

GEM lifestyle modification \& continuous glucose monitoring

Behavioral: GEM lifestyle modification & continuous glucose monitoring; Other: Routine Care

Routine Care

ACTIVE COMPARATOR

Subject's current t2d treatment

Other: Routine Care

Interventions

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.

GEM+CGM

Routine Care OTHER

Subject's current t2d treatment

GEM+CGM; Routine Care

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes
• Between the ages of 21 and 80
• Failed on an oral medication regimen (HbA1c \> 7.5%).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead
• DexCom, Inc.: collaborator

Study Sites (1)

University of Virginia, Dept. of Psychiatry and Neurobehavioral Sciences

Charlottesville, Virginia, 22908, United States

Location

Related Publications (59)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Daniel J Cox, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Departments of Psychiatry, Internal Medicine and Ophthalmology

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: July 5, 2017
• Study Start: July 19, 2018
• Primary Completion: January 23, 2020
• Study Completion: January 23, 2020
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)