Diabetes in African Youth

University of Minnesota (UMN)

Status and phase: Enrolling; Phase 4

Conditions: type1diabetes

Treatments: Device: Libre 2; Device: Device for SMBG and Libre Pro

Study type: Interventional

Funder types: Other

Identifiers

NCT05454176

PEDS-2022-31031

Details and patient eligibility

About

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).

Enrollment: 180 estimated patients

Sex: All

Ages: 4 to 26 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups, including a placebo group

Libre 2

Experimental group

Description:

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. Primary outcome measurement occurs at 6 months.

Treatment:

Device: Libre 2

SMBG levels 3x/daily (standard diabetes management)

Placebo Comparator group

Description:

Half of subjects will be given sufficient test strips to test 3x per day for the first 6 months of the study, as is usual clinical practice. They wear a blinded FreeStyle Libre Pro CGM monthly during this time-the blinded device is simply to collect study data, the data will not be available to the patient or their provider for clinical use. They will use the 3x daily SMBG data for insulin adjustment, as per usual standard of care. For the final 6 months (7-12), this group will switch to unblinded CGM patients and providers will have full access to CGM data.

Treatment:

Device: Device for SMBG and Libre Pro