Ignite Creation Date:
2024-05-06 @ 6:12 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05580978
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2022-10-06
Brief Title:
CGM Plus GEM in Prediabetes
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Libre 2 CGM Plus Glycemic Excursion mIniMization GEM in the Treatment of PrEDiabEtes
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPEDE
Brief Summary:
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
Detailed Description:
For people with prediabetes it may be possible to delay or prevent the progression to diabetes by reducing postprandial glucose PPG The Glycemic Excursion Minimization GEM lifestyle intervention guide can reduce PPG in people with type 2 diabetes and has been studied in this population with continuous glucose monitor CGM feedback to help the user learn what elevates and lowers their PPG This study examines if the GEM lifestyle intervention guide plus continuous feedback from the FreeStyle Libre 2 CGM and FitBit will allow participants with prediabetes with HbA1c 60-64 to 1 improve their metabolic status by illustrating the effects of their routine food and physical activity choices on their glucose levels and variability more than Routine Care RC and 2 to enhance these investigations by adding comprehensive plasma proteomics to the analyses The investigators will recruit up to 36 adult participants with prediabetes through the University of Colorado with the goal of having at least 30 participants complete the study Participants will be randomized to the intervention or RC Those randomized to the intervention will be given a GEM treatment manual Libre2 CGM and an activity monitor and will follow the GEM lifestyle intervention guide for 4 months Those participants randomized to RC will follow recommendations from their primary care provider RC participants will have the opportunity to receive GEM four months after consenting and completing the RC pre-post assessments if they meet eligibility criteria It is anticipated that 50 of the RC participants will wantbe able to cross over to GEM upon completion of RC Pre-post blinded CGM data and activity data clinical and psychosocial outcomes will be collected and analyzed It is anticipated that this pilot project will demonstrate the benefits of using GEM plus FreeStyle Libre 2 and FitBit to reduce percentage of CGM readings 120 mgdL from blinded pre-post FreeStyle Libre Pro as well as reduce BMI and depressive symptoms and increase modified diabetes empowerment Comprehensive proteomics will be measured on small samples of EDTA treated venous blood Individual proteins and protein pathways will be measured for each of the participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None