Lifestyle Guide + Glucose Monitoring for Prediabetes
(IMPEDE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the impact of a lifestyle guide called GEM, combined with continuous glucose monitoring (CGM) and a fitness tracker, on managing prediabetes. The goal is to determine if this approach can help people better control their blood sugar levels. Participants will either use these tools or continue with their usual care for comparison. Individuals diagnosed with prediabetes, having an A1C between 6.0 and 6.4, and owning a smartphone might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve prediabetes management.
Will I have to stop taking my current medications?
If you are currently taking any diabetes medication or medication that affects insulin resistance, you will not be eligible to participate in this trial.
What prior data suggests that this protocol is safe for prediabetes?
Research shows that following the GEM (Glycemic Excursion Minimization) lifestyle guide can help control blood sugar levels. In earlier studies, people using GEM saw a decrease in their HbA1c levels, a measure of blood sugar control. For example, one study found that participants lowered their HbA1c from 8.9% to 7.6%, indicating that GEM is effective and safe for managing blood sugar.
The study did not report any serious side effects, suggesting that GEM is likely well-tolerated. Although this study focuses on people with prediabetes, similar lifestyle changes have been safely used by those with type 2 diabetes, offering reassurance about the safety of this approach for prediabetes. Overall, the evidence supports GEM as a safe choice for managing blood sugar levels and possibly preventing diabetes.12345Why are researchers excited about this trial?
Researchers are excited about the GEM treatment combined with continuous glucose monitoring (CGM) and an activity monitor for prediabetes because it offers a more integrated and personalized approach than standard care options like lifestyle changes and medications. Unlike traditional treatments that might not provide real-time data, this approach allows individuals to track their glucose levels continuously and adjust their activities accordingly, which can lead to more precise management of blood sugar levels. Additionally, the use of technology like FitBit for activity monitoring helps encourage a more active lifestyle, potentially preventing the progression to diabetes more effectively.
What evidence suggests that this trial's treatments could be effective for prediabetes?
Research has shown that lifestyle changes can effectively manage prediabetes. One study found that about 93% of individuals who made lifestyle changes within a few years of developing prediabetes experienced significant improvements. These changes often lead to better blood sugar control, improved fitness, and weight loss. In this trial, participants in the GEM + CGM + Activity Monitor arm will use digital tools, such as devices that monitor blood sugar and track activity, to easily manage their progress. The American Diabetes Association recommends losing at least 7% of body weight to help prevent prediabetes from progressing to diabetes. Overall, combining lifestyle changes with digital tools appears promising for effectively managing prediabetes.678910
Who Is on the Research Team?
Tamara Oser, MD
Principal Investigator
Associate Professor, Dept. Family Medicine
Are You a Good Fit for This Trial?
This trial is for adults aged 25-70 with prediabetes, an A1C level of 6.0-6.4, who can read English and use a smartphone. It's not for those with kidney disease, diabetes mellitus, on diabetes medication or drugs affecting metabolic control like prednisone, or have conditions limiting exercise.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants follow the GEM lifestyle intervention guide with CGM and activity monitor for 4 months
Routine Care
Participants receive usual care from their primary care provider
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GEM
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
Abbott Diabetes Care
Industry Sponsor
Robert B. Ford
Abbott Diabetes Care
Chief Executive Officer since 2020
Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business
Dr. Mahmood Kazemi
Abbott Diabetes Care
Chief Medical Officer
Bachelor's and Master's degrees from Stanford University, MD from the University of California, San Francisco
University of Virginia
Collaborator