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Lifestyle Guide + Glucose Monitoring for Prediabetes (IMPEDE Trial)

N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4.5 months
Awards & highlights

IMPEDE Trial 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.Check my eligibility
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.See study design
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.

IMPEDE Trial Eligibility Criteria

Inclusion Criteria

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

IMPEDE Trial 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

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

IMPEDE 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
1,729 Previous Clinical Trials
2,143,656 Total Patients Enrolled
Abbott Diabetes CareIndustry Sponsor
63 Previous Clinical Trials
24,705 Total Patients Enrolled
University of VirginiaOTHER
753 Previous Clinical Trials
1,245,004 Total Patients Enrolled

Media Library

GEM Clinical Trial Eligibility Overview. Trial Name: NCT05580978 — N/A
Prediabetes Research Study Groups: Routine Care, GEM + CGM + Activity Monitor
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For whom is eligibility criteria being assessed for this experiment?

"In order to be part of this clinical trial, participants must possess pre-diabetic symptoms and have attained the age of 25 but not yet reached 70. At present, 36 patients are being recruited."

Answered by AI

Does this experimental protocol accept individuals aged 40 or greater?

"This clinical trial is accessible to those between 25 and 70 years of age. Conversely, there are 15 studies available for minors and 184 dedicated to seniors."

Answered by AI

Are there any remaining openings in this trial for participants?

"The clinical trial, which was originally published on November 1st 2022 and revised two days later, is actively seeking volunteers according to the information hosted on clinicialtrials.gov."

Answered by AI

How many participants are engaged in this experiment?

"Indeed, according to clinicaltrials.gov, this medical trial is currently recruiting patients. The study was made available on November 1st 2022 and its most recent update was December 2nd 2022; at present it requires 36 volunteers from a single site."

Answered by AI

Who else is applying?

What state do they live in?
North Dakota
Colorado
Texas
Other
What site did they apply to?
University of Colorado- Anschutz Medical Campus
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0

What questions have other patients asked about this trial?

Can we do virtual visits and labs local to me? Will I be able to do the study in Austin Texas?
PatientReceived 2+ prior treatments
Do you work with clients who live outside of Colorado?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

learn about pre dia. I need to know more about pre- diabetes. I’m trying to get my A1C down through diet and exercise.
PatientReceived 2+ prior treatments
It would be great to lose some weight and lower blood glucose! To try and control this so I don’t become a full blown diabetic.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. University of Colorado- Anschutz Medical Campus: < 48 hours
~5 spots leftby Jul 2024