Diabetes in African Youth

Study Overview
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Brief Summary
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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). After a 2 week assessment with blinded CGM when a potential subject's ability to wear CGM is confirmed, subjects will be enrolled a 12 month study, with the primary endpoint at 6 months. All subjects will receive monthly diabetes self-management education. Half of patients (n=90) will be given an unblinded FreeStyle Libre 2 CGM for the entire 12 months. They will be able to see their glucose levels in real time. Half (n=90) will be given sufficient test strips for 3x daily SMBG while wearing blinded CGM for 6 months (control group). They will switch to unblinded CGM months 6-12.

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

Conditions
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type1diabetes

Intervention / Treatment
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* Device: Libre 2
* Device: Libre Pro


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 4 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, non-blinded, phase 4 clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Libre 2<br>Half of patients will be randomized to wear an unblinded FreeStyle Libre 2 CGM for 12 months. Sensor glucose data will be continuously available to patients and their providers. | Device: Libre 2<br>* The unblinded FreeStyle Libre 2 CGM will be placed every two weeks during months 0-12 for the CGM Cohort, and months 6-12 for the Control 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 test strips to test a fingerpoke glucose for confirmation if their blood glucose level is &lt;60 by CGM. They will keep track of the number of times this is necessary. Patients will return used sensors at each clinic visit. The study team will upload the data to a study website. Patients and care providers will have access to unblinded sensor data for clinical use.<br>|
| Active Comparator: Libre Pro<br>Half of subjects will be given sufficient test strips to test 3x per day for the first 6 months and will wear a blinded FreeStyle Libre Pro CGM monthly to collect study data. During this period, they and their medical teams will not be able to see CGM glucose data, in order to maintain the blinded control conditions. They will use the 3x daily SMBG data for insulin adjustment, as per usual standard of care. For the final 6 months (6-12), this group will switch to unblinded CGM where patients and providers will have full access to CGM data. | Device: Libre Pro<br>* The blinded FreeStyle Libre Pro CGM will be used to provide control data. Sensors last for up to 14 days, and the goal is at least 7 days of sensor data per sensor use, with a minimum of 3 days. Blinded sensors will be placed at -2 weeks during the baseline period in all subjects, and monthly thereafter months 0-6 for the Control Group. They will return all used sensors at each clinic visit. The study team will upload the data to a study website. Neither patients nor the local research teams will have access to the blinded sensor data for clinical use until the end of months 0-6 to preserve the blinding. They will instead rely on SMBG values as per usual routine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose Time-in-Range | The change in glucose TIR while wearing the unblinded CGM will be compared to change in TIR in patients performing 3x/day SMBG (wearing a blinded CGM for endpoint measurement) | 1 year post enrollment | 
| Cost analysis of CGM | Cost analysis on flash glucose monitoring compared to 3x/day SMBG, to determine whether this technology is cost effective in the setting of a low-resource nation. | 1 year post enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CGM, Uganda, type 1 diabetes, continuous glucose monitor, resource poor nations