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Lifestyle Guide + Glucose Monitoring for Prediabetes (IMPEDE Trial)

N/A
Waitlist Available
Led By Tamara Oser, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 25-70 years
Be older than 18 years old
Must not have
Diagnosis of diabetes mellitus
Currently taking any diabetes medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4.5 months
Awards & highlights
No Placebo-Only Group

Summary

This trial studies how a lifestyle guide, glucose monitoring, and activity tracking can help people with prediabetes.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves lifestyle changes rather than medication, side effects may include discomfort from wearing devices or changing diet and exercise habits but are generally minimal compared to drug interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 25 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with diabetes.
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I am currently on medication for diabetes.
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I cannot walk 120 steps per minute for 10 minutes due to a health condition.
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I am on medication that affects my blood sugar levels, like prednisone.
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I am currently undergoing or planning to start cancer treatment.
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I cannot follow a low carbohydrate diet due to a health condition like gastroparesis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4.5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4.5 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in percentage of CGM glucose readings > 120 mg/dL
Secondary study objectives
Change in Body Mass Index
Change in Cardiovascular Risk
Depressive Symptoms
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: GEM + CGM + Activity MonitorExperimental Treatment1 Intervention
GEM plus CGM and Activity Monitor (FitBit)
Group II: Routine CareActive Control1 Intervention
Usual care already being received for prediabetes as treated by their care team.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GEM
2017
N/A
~540

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,804 Previous Clinical Trials
2,822,130 Total Patients Enrolled
Abbott Diabetes CareIndustry Sponsor
64 Previous Clinical Trials
25,462 Total Patients Enrolled
University of VirginiaOTHER
782 Previous Clinical Trials
1,315,689 Total Patients Enrolled

Media Library

GEM Clinical Trial Eligibility Overview. Trial Name: NCT05580978 — N/A
Prediabetes Research Study Groups: GEM + CGM + Activity Monitor, Routine Care
Prediabetes Clinical Trial 2023: GEM Highlights & Side Effects. Trial Name: NCT05580978 — N/A
GEM 2023 Treatment Timeline for Medical Study. Trial Name: NCT05580978 — N/A
Prediabetes Patient Testimony for trial: Trial Name: NCT05580978 — N/A
~1 spots leftby Jan 2025
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