Diabetes in African Youth

Official title

Diabetes in African Youth: Improving Glucose Time-In-Range (DAYTime, Randomized Clinical Trial)

Overview

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).

Interventions

• Device Libre 2
  The unblinded FreeStyle Libre 2 CGM will be placed every two weeks during months 0-12 for the CGM Cohort. Patients will be taught to insert the sensor themselves. They will be given a 1 month supply at each monthly clinic visit and extra sensors in case a sensor falls out early. Patients will be given SMBG test strips to test capillary glucose for confirmation of any CGM glucose level \<=60mg/dl. They will keep track of the number of times this is necessary. Patients will return used sensors at
• Device Device for SMBG and Libre Pro
  A glucose meter and sufficient teststrips for fingerpoke glucose monitoring 3x/day will be provided for months 1-6. This is standard-of-care in Uganda. Glucose meters will be downloaded monthly in clinic as per usual clinical practice. DeviceBlinded CGM device: Libre Pro (blinded data collection device, not an intervention) The blinded FreeStyle Libre Pro CGM will be inserted at each monthly clinic visit to provide control data, months 0-6 for the Control Group. They will return all used sensor

Primary outcome measures

• Glucose Time-in-Range [Time frame: 6 months]
• Cost analysis of CGM [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Minnesota — Minneapolis

Identifiers

NCT: NCT05454176 · PEDS-2022-31031

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗