Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04632849
Status:
COMPLETED
Last Update Posted:
2021-10-05
First Post:
2020-11-03
Brief Title:
The Use of Libre to Improve Metabolic Control and Reduce Reliance on Medication
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
The Use of Libre to Educate Motivate and Activate Adults With Newly Diagnosed Type 2 Diabetes to Improve Metabolic Control and Reduce Their Reliance on Medication A Pilot Study
Status:
COMPLETED
Status Verified Date:
2021-10
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:
None
Brief Summary:
GEM Glycemic Excursion Minimization is a new lifestyle treatment for type 2 diabetes that aims to lower glucose levels after meals and snacks This is different from the current lifestyle treatment which is to lose weight This study is trying to find out if people who are newly diagnosed with type 2 diabetes can use a continuous glucose monitor together with the GEM lifestyle to improve control of their diabetes Study participants will follow the GEM lifestyle for 4 months 1 month of treatment and 3 months of maintenance instead of seeking usual care medications or weight loss programs to lower blood glucose
Detailed Description:
For people who are newly diagnosed with Type 2 Diabetes T2D it might be possible to delay or prevent the need for diabetic medications by reducing postprandial glucose PPG Our Glycemic Excursion Minimization GEM lifestyle intervention can reduce PPG but it depends on blood glucose feedback to help the user learn what elevates their PPG This study examines if continuous feedback from the Libre 2 continuous glucose monitor CGM will be advantageous for reaching the goals of GEM We will recruit 18 adult participants newly diagnosed with type 2 diabetes who are interested in using the Libre 2 CGM Six participants will be recruited from each of the primary care clinics at the University of Virginia Dr Cox the University of Colorado Dr Oser and the University of West Virginia East Branch Dr Cucuzzella Each site will also search their medical records to select 4 participants who match their study participants meet the study criteria but are being treated with routine care These data will form the Routine Care control group n12 Routine Care participants will follow their doctors treatment recommendations while GEM participants will complete the 1-month self-directed GEM lifestyle training using the Libre 2 CGM and a FitBit to monitor progress They will then maintain the GEM lifestyle for 3 more months The Total Treatment Effect a measure of treatment effectiveness that considers both A1c and medication changes will be calculated pre- and post-treatment from medical record data CGM data from GEM participants will be collected and analyzed CGM sensor use will be tracked to estimate participant engagement We anticipate this multi-center pilot project will demonstrate the benefits of using Libre 2 with a structured lifestyle intervention designed to reduce postprandial blood glucose excursions for individuals newly diagnosed with T2D
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?:
None
Is an FDA AA801 Violation?:
None