Diabetes in African Youth

RECRUITING

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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). A second primary endpoint is to perform a cost analysis on flash glucose monitoring compared to 3x/day SMBG, to determine whether this technology is cost-effective in the setting of a less-resourced nation. After a 2 week assessment with blinded CGM when a potential subject's ability to wear CGM is confirmed, subjects will be enrolled for 12 months in randomized, open label study, with a primary endpoint measurement at 6 months. All subjects will receive monthly diabetes self-management education. For the first six months, months 1-6: * Half of patients (n=90) will be randomized to an unblinded FreeStyle Libre 2 CGM.They and their care providers will be able to continuously see their CGM glucose levels to assist in insulin adjustment. * Half of patients (n=90) will be given sufficient test strips for 3x daily SMBG while wearing blinded CGM (control group). Neither they nor their care providers will be able to see their CGM glucose levels (the blinded CGM is simply for outcome measurement, not an intervention). As per usual clinical practice, only the SMBG glucose levels will be available to assist in insulin adjustment. * The change between baseline to 6 months in CGM-derived glucose percent time-in- range will be compared between groups (first primary study endpoint). For the second six months, months 7-12: * The control group will switch to unblinded CGM months 7-12 (their data months 7-12 months will be compared to their data months 1-6 as part of the primary endpoint assessment). * The patients who wore the unblinded CGM months 1-6 will continue for another 6 months to assess the impact of wearing the CGM for 12 continuous months (a secondary endpoint). Once the clinical portion of the study is complete, study investigators who are health economists from the Uganda Ministry of Health will perform a costs analysis (second primary endpoint).

Conditions:

🦠 type1diabetes

🗓️ Study Start (Actual) 15 August 2022

🗓️ Primary Completion (Estimated) 15 August 2027

✅ Study Completion (Estimated) 15 August 2027

👥 Enrollment (Estimated) 180

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE4

Locations:

📍 Minneapolis, Minnesota, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

* Children and youth in Uganda, age 4-26 years at the beginning of the baseline assessment
* T1D (determined by clinical criteria, as autoantibody testing is not regionally available) of at least 12 months duration at the beginning of the baseline assessment
* Receiving insulin therapy
* Access to a cell phone (nearly ubiquitous in Uganda, even in remote areas)
* At least one parent or guardian (or as per local regulations) is present in clinic and able to give consent for children under 18 years of age (those age 18-26 may give consent for themselves)

Exclusion Criteria:

* Unwilling or unable to be seen monthly at the pediatric diabetes clinic
* Pregnant or breast-feeding; women likely to become pregnant in the next year
* Major medical conditions which the investigator feels would interfere with study participation
* Patient already has CGM
* Inability during the baseline assessment period to wear the sensor for at least 7 days or return it
* Participant deemed unlikely or unable to comply with the protocol

Ages Eligible for Study: 4 Years to 26 Years (CHILD, ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 6 July 2022
First Submitted that Met QC Criteria 6 July 2022
First Posted 12 July 2022

Study Record Updates

Last Update Submitted that Met QC Criteria 28 December 2023
Last Update Posted 3 January 2024
Last Verified December 2023