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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4.5 months

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

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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,786 Previous Clinical Trials

2,787,572 Total Patients Enrolled

Abbott Diabetes CareIndustry Sponsor

63 Previous Clinical Trials

24,733 Total Patients Enrolled

University of VirginiaOTHER

771 Previous Clinical Trials

1,284,261 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

~13 spots leftby Sep 2025

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