Libre Pro for Diabetes Mellitus

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of Minnesota, Minneapolis, MN
Diabetes Mellitus+2 More
Libre 2 - Device
Eligibility
< 65
All Sexes
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Study Summary

This RCT aims to improve T1D care in East African children and young adults by testing the hypothesis that enabling patients to continuously monitor glucose levels with flash CGM technology will improve glucose time-in-range (glucose level 70-180 mg/dl). After a 2 week assessment with blinded CGM when a potential subject's ability to wear CGM is confirmed, subjects will be enrolled a 12 month study, with the primary endpoint at 6 months. All subjects will receive monthly diabetes self-management education. Half of patients (n=90) will be given an unblinded FreeStyle Libre 2 CGM for the entire 12 months. They will be able to see their glucose levels in real time. Half (n=90) will be given sufficient test strips for 3x daily SMBG while wearing blinded CGM for 6 months (control group). They will switch to unblinded CGM months 6-12.

Eligible Conditions

  • Diabetes Mellitus
  • type1diabetes

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Diabetes Mellitus

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 1 year post enrollment

1 year post enrollment
Cost analysis of CGM
Glucose Time-in-Range

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Diabetes Mellitus

Trial Design

2 Treatment Groups

Libre Pro
1 of 2
Libre 2
1 of 2
Active Control

180 Total Participants · 2 Treatment Groups

Primary Treatment: Libre Pro · No Placebo Group · Phase 4

Libre Pro
Device
ActiveComparator Group · 1 Intervention: Libre Pro · Intervention Types: Device
Libre 2
Device
ActiveComparator Group · 1 Intervention: Libre 2 · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year post enrollment
Closest Location: University of Minnesota · Minneapolis, MN
Photo of University of Minnesota   1Photo of University of Minnesota   2Photo of University of Minnesota  3
1993First Recorded Clinical Trial
50 TrialsResearching Diabetes Mellitus
828 CompletedClinical Trials

Eligibility Criteria

Age < 65 · All Participants · 5 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.