Actively Recruiting
Diabetes in African Youth: Improving Glucose Time-In-Range Using FreeStyle Libre 2 CGM in a Randomized Clinical Trial
Led by University of Minnesota · Updated on 2025-11-25
180
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ways to improve care for children and young adults with type 1 diabetes in East Africa by studying how continuous glucose monitoring (CGM) affects blood sugar control. The study aims to see if using flash CGM technology helps patients keep their glucose levels within a healthy range more often. Another goal is to compare the cost of flash CGM with the usual method of checking blood sugar three times a day to see if the technology is affordable in less-resourced settings. The study lasts 12 months and starts with a 2-week period where participants wear a blinded CGM to confirm they can use the device. For the first six months, half the participants will use an unblinded FreeStyle Libre 2 CGM, which shows real-time glucose data to them and their healthcare providers to help adjust insulin. The other half will continue their usual care with fingerstick blood sugar checks three times daily while wearing a blinded CGM that does not display data. After six months, the control group switches to the unblinded CGM, and the first group continues using it to assess longer-term effects. Participants will receive monthly diabetes self-management education and attend monthly clinic visits to return used sensors and download data. Researchers will measure glucose time-in-range at six months and analyze the cost-effectiveness of CGM at one year. The study is open-label and randomized, enrolling children and young adults aged 4 to 26 years with type 1 diabetes who have been on insulin for at least a year. Data collected will help understand the impact of CGM technology in this population and setting.
CONDITIONS
Brief Title
Diabetes in African Youth
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and youth aged 4 to 26 years at the start of the baseline assessment
- Diagnosed with type 1 diabetes for at least 12 months
- Currently receiving insulin therapy
- Have access to a cell phone
- Have at least one parent or guardian able to consent for those under 18; participants 18-26 can consent for themselves
You will not qualify if you...
- Unwilling or unable to attend monthly clinic visits
- Pregnant or breastfeeding, or likely to become pregnant within one year
- Have major medical conditions interfering with study participation
- Already using continuous glucose monitoring
- Unable to wear the sensor for at least 7 days or return it during baseline
- Considered unlikely or unable to follow the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive either unblinded FreeStyle Libre 2 CGM or standard glucose monitoring with test strips and a blinded CGM device during the first 6 months. After 6 months, all participants use the unblinded FreeStyle Libre 2 CGM system.
Monthly clinic visits for up to 12 months
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
B
Beth Pappenfus
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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