Lifestyle Guide + Glucose Monitoring for Prediabetes

(IMPEDE Trial)

Overseen By Tamara K. Oser, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Diabetes medications, Prednisone

Disqualifiers: Diabetes, Kidney disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Tamara Oser, MD

Principal Investigator

Associate Professor, Dept. Family Medicine

Eligibility Criteria

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

Able to read English, as the GEM guide is currently only available in English

You have been diagnosed with prediabetes.

I am between 25 and 70 years old.

Exclusion Criteria

I have been diagnosed with diabetes.

Anticipates moving within the next 4 months

I am currently on medication for diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow the GEM lifestyle intervention guide with CGM and activity monitor for 4 months

16 weeks

Monthly visits (in-person or virtual)

Routine Care

Participants receive usual care from their primary care provider

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4.5 months

Treatment Details

Interventions

• GEM

Trial Overview The study tests the GEM lifestyle guide combined with continuous glucose monitoring (CGM) and a FitBit activity tracker to manage blood sugar levels in people with prediabetes compared to routine care without these tools.

Participant Groups

Group I: GEM + CGM + Activity Monitor Experimental Treatment 1 Intervention

GEM plus CGM and Activity Monitor (FitBit)

Group II: Routine Care Active Control 1 Intervention

Usual care already being received for prediabetes as treated by their care team.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Abbott Diabetes Care

Industry Sponsor

Trials

67

Recruited

25,600+

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

Trials

802

Recruited

1,342,000+