The Use of Libre to Improve Metabolic Control and Reduce Reliance on Medication

NCT04632849 | Completed

• 1 other identifier: 22635
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

GEM (Glycemic Excursion Minimization) is a new lifestyle treatment for type 2 diabetes that aims to lower glucose levels after meals and snacks. This is different from the current lifestyle treatment, which is to lose weight. This study is trying to find out if people who are newly diagnosed with type 2 diabetes can use a continuous glucose monitor together with the GEM lifestyle to improve control of their diabetes. Study participants will follow the GEM lifestyle for 4 months (1 month of treatment and 3 months of maintenance) instead of seeking usual care (medications or weight loss programs) to lower blood glucose.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Total Treatment Effect (TTE)

  Measures the effect of the intervention on HbA1c. The TTE factors out the confounding effects of diabetes medications on HbA1c by adjusting for each medication's HbA1c-lowering equivalent.

  Change from baseline TTE at 3 months post-intervention

Secondary Outcomes (9)

• Blood glucose

  Change from baseline blood glucose at 3 months post-intervention

• Physical activity

  Change from baseline physical activity at 3 months post-intervention

• Food Choice Questionnaire: High Glycemic Load (HGL)

  Change from baseline Food Choice Questionnaire HGL at 3 months post-intervention

• Food Choice Questionnaire: Low Glycemic Load (LGL)

  Change from baseline Food Choice Questionnaire LGL at 3 months post-intervention

• Patient Health Questionnaire (PHQ-8)

  Change from baseline PHQ-8 at 3 months post-intervention

Study Arms (1)

GEM + CGM

EXPERIMENTAL

A self-directed lifestyle intervention for controlling Type 2 Diabetes

Behavioral: GEM + CGM

Interventions

GEM + CGM BEHAVIORAL

Participants follow the GEM guidebook for 4 months (1 month of intervention and 3 months of maintenance) while wearing a FitBit activity monitor and a Freestyle Libre 2 CGM to provide feedback about activity and blood glucose. The GEM guidebook covers Routine choices, Recovering from blood glucose excursions, Reducing blood glucose excursions, and Maintenance.

GEM + CGM

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form.
• Willing to comply with study procedures and be available for the entire study.
• to 85 years of age, inclusive.
• Diagnosed with Type 2 Diabetes within the last 12 months.
• HbA1c between 6.5% and 11.5%.
• Medical record contains HbA1c, lipid panel, BMI and blood pressure measures collected in the past three months.
• to 85 years of age, inclusive.
• Diagnosed with Type 2 Diabetes within the last 12 months.
• HbA1c between 6.5% and 11.5%.
• Medical record contains HbA1c, lipid panel, BMI and blood pressure measures collected in the past three months.

You may not qualify if:

• Has Type 1 Diabetes
• Currently takes diabetes medication
• Currently takes medication that can interfere with metabolic control, such as prednisone
• Has a condition that precludes a low carbohydrate diet, such as gastroparesis
• Has a physical or medical condition that precludes walking 120 steps per minute, for 10 minutes or longer
• Has kidney disease.
• Is receiving cancer treatment
• Cannot speak English
• Has blindness
• Is pregnant or anticipates becoming pregnant in the next 4 months
• Anticipates moving away within the next 4 months
• Took medication that can interfere with metabolic control, such as prednisone
• Had a condition that precludes a low carbohydrate diet, such as gastroparesis
• Had a physical or medical condition that precludes walking 120 steps per minute, for 10 minutes or longer
• Had kidney disease.

Sponsors & Collaborators

• University of Virginia: lead
• University of Colorado, Denver: collaborator
• West Virginia University: collaborator

Study Sites (1)

Dept. of Psychiatry and Neurobehavioral Sciences, University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• Cox DJ, Banton T, Moncrief M, Conaway M, Diamond A, McCall AL. Minimizing Glucose Excursions (GEM) With Continuous Glucose Monitoring in Type 2 Diabetes: A Randomized Clinical Trial. J Endocr Soc. 2020 Aug 18;4(11):bvaa118. doi: 10.1210/jendso/bvaa118. eCollection 2020 Nov 1.

  PMID: 33094208 BACKGROUND

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All participants will receive the GEM intervention.

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 17, 2020
• Study Start: November 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)