Clinical trial NCT05580978: CGM Plus GEM in Prediabetes
Official title: Libre 2 CGM Plus Glycemic Excursion mIniMization (GEM) in the Treatment of PrEDiabEtes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Keywords: prediabetes
lifestyle guide
continuous glucose monitor
prevention
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Abbott Diabetes Care
name: University of Virginia
First posted: 2022-10-14
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study is designed to look into the effect of a lifestyle management guide called GEM (Glycemic Excursion Minimization) alongside continuous glucose monitoring (CGM) and an activity monitor (FitBit) and the effect this can have on persons with prediabetes.

Detailed description: For people with prediabetes, it may be possible to delay or prevent the progression to diabetes by reducing postprandial glucose (PPG). The Glycemic Excursion Minimization (GEM) lifestyle intervention guide can reduce PPG in people with type 2 diabetes and has been studied in this population with continuous glucose monitor (CGM) feedback to help the user learn what elevates and lowers their PPG. This study examines if the GEM lifestyle intervention guide plus continuous feedback from the FreeStyle Libre 2 CGM and FitBit will allow participants with prediabetes with HbA1c 6.0-6.4% to (1) improve their metabolic status by illustrating the effects of their routine food and physical activity choices on their glucose levels and variability, more than Routine Care (RC), and (2) to enhance these investigations by adding comprehensive plasma proteomics to the analyses. The investigators will recruit up to 36 adult participants with prediabetes through the University of Colorado, with the goal of having at least 30 participants complete the study. Participants will be randomized to the intervention or RC. Those randomized to the intervention will be given a GEM treatment manual, Libre2 CGM, and an activity monitor and will follow the GEM lifestyle intervention guide for 4 months. Those participants randomized to RC will follow recommendations from their primary care provider. RC participants will have the opportunity to receive GEM four months after consenting and completing the RC pre-post assessments if they meet eligibility criteria. It is anticipated that 50% of the RC participants will want/be able to cross over to GEM upon completion of RC. Pre-post blinded CGM data and activity data, clinical, and psychosocial outcomes will be collected and analyzed. It is anticipated that this pilot project will demonstrate the benefits of using GEM plus FreeStyle Libre 2 and FitBit to reduce percentage of CGM readings \>120 mg/dL, from blinded pre-post FreeStyle Libre Pro, as well as reduce BMI and depressive symptoms and increase modified diabetes empowerment. Comprehensive proteomics will be measured on small samples of EDTA treated venous blood. Individual proteins and protein pathways will be measured for each of the participants.

Eligibility criteria: Inclusion Criteria:

* Age 25-70 years
* A1C 6.0-6.4
* Documented diagnosis of prediabetes
* Have a smart phone
* Able to read English, as the GEM guide is currently only available in English
* Willing and able to follow the study procedures as instructed

Exclusion Criteria:

* Diagnosis of diabetes mellitus
* Currently taking any diabetes medication
* Currently taking medication that promotes insulin resistance or otherwise interferes with metabolic control (e.g., 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 documented kidney disease that would preclude participation in study per PI discretion
* Active or planned cancer treatment
* Extreme visual or hearing impairment that would impair ability to use real-time CGM
* Pregnant or anticipates becoming pregnant in the next 4 months
* Anticipates moving within the next 4 months
* Treating physician, for any reason, considers their patient inappropriate for the study (e.g., uncontrolled bipolar disease)

Primary outcomes:
measure: Change in percentage of CGM glucose readings > 120 mg/dL
timeFrame: 4.5 months
Secondary outcomes:
measure: Change in HbA1c
timeFrame: 4.5 months
measure: Change in Glucose Variability
timeFrame: 4.5 months
measure: Change in Body Mass Index
timeFrame: 4.5 months
measure: Change in Cardiovascular Risk
timeFrame: 4.5 months
measure: Change in Empowerment
timeFrame: 4.5 months
measure: Change in Depressive Symptoms
timeFrame: 4.5 months
measure: Change in Diabetes Knowledge
timeFrame: 4.5 months
measure: Dietary Habits
timeFrame: 4.5 months
measure: Motivation and Attitudes Toward Changing Health
timeFrame: 4.5 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado- Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: Associate Professor, Dept. Family Medicine
name: Tamara Oser, MD
role: PRINCIPAL_INVESTIGATOR
References: