- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05580978
CGM Plus GEM in Prediabetes (IMPEDE)
April 9, 2024 updated by: University of Colorado, Denver
Libre 2 CGM Plus Glycemic Excursion mIniMization (GEM) in the Treatment of PrEDiabEtes
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Britney K Prince, BS
- Phone Number: 303-724-8968
- Email: Britney.prince@cuanschutz.edu
Study Contact Backup
- Name: Elizabeth Westfeldt, BSN, RN
- Phone Number: 303-724-2445
- Email: elizabeth.westfeldt@cuanschutz.edu
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado- Anschutz Medical Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
23 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GEM + CGM + Activity Monitor
GEM plus CGM and Activity Monitor (FitBit)
|
The intervention group will be given Libre 2 supplies for 4 months, an activity monitor, and the 4-chapter GEM paper guide.
The intervention group will complete a virtual or inperson study visit where they will receive instructions on how to apply their unblinded Freestyle Libre and connect it to the study account, as well as how to register their Fitbit to the study account.
Participants will receive one telephone call to review use of the GEM Guide and call at two weeks and six weeks later when the probability of dropouts from lifestyle intervention peaks.
Participants will follow the self-directed GEM guide for 4 months (a 1-month treatment period followed by a 3-month maintenance period) while wearing a FitBit activity monitor and a Freestyle Libre 2 CGM.
|
Active Comparator: Routine Care
Usual care already being received for prediabetes as treated by their care team.
|
Participant's current prediabetes treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in percentage of CGM glucose readings > 120 mg/dL
Time Frame: 4.5 months
|
Change in percentage of CGM glucose readings > 120 mg/dL from pre-intervention blinded CGM to post-intervention blinded CGM.
|
4.5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in HbA1c
Time Frame: 4.5 months
|
Change in HbA1c from baseline to post-intervention.
|
4.5 months
|
Change in Glucose Variability
Time Frame: 4.5 months
|
Change in glucose variability (GV%) as measured by CGM, from baseline to post-intervention.
|
4.5 months
|
Change in Body Mass Index
Time Frame: 4.5 months
|
Change in Body Mass Index (BMI) from baseline to post-intervention.
|
4.5 months
|
Change in Cardiovascular Risk
Time Frame: 4.5 months
|
Change in cardiovascular risk as calculated by a validated risk calculator from baseline to post-intervention
|
4.5 months
|
Change in Empowerment
Time Frame: 4.5 months
|
Change in empowerment as measured by modified Diabetes Empowerment Scale, from baseline to post-intervention.
|
4.5 months
|
Change in Depressive Symptoms
Time Frame: 4.5 months
|
Change in depression score as measured by PHQ-8 at baseline and post-intervention.
|
4.5 months
|
Change in Diabetes Knowledge
Time Frame: 4.5 months
|
Change in diabetes knowledge as measured by a modified Diabetes Knowledge Scale from baseline to post-intervention.
|
4.5 months
|
Dietary Habits
Time Frame: 4.5 months
|
Change in dietary habits as measured by Carbohydrate Routine Consumption Scale from baseline to post-intervention.
|
4.5 months
|
Motivation and Attitudes Toward Changing Health
Time Frame: 4.5 months
|
Change in Motivation and Attitudes Toward Changing Health (MATCH) score from baseline to post-intervention.
|
4.5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tamara Oser, MD, Associate Professor, Dept. Family Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2022
Primary Completion (Estimated)
July 1, 2024
Study Completion (Estimated)
July 1, 2024
Study Registration Dates
First Submitted
October 6, 2022
First Submitted That Met QC Criteria
October 12, 2022
First Posted (Actual)
October 14, 2022
Study Record Updates
Last Update Posted (Actual)
April 10, 2024
Last Update Submitted That Met QC Criteria
April 9, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-4931
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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