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Diabetes in African Youth

Primary Purpose

type1diabetes

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Libre 2

Libre Pro

About this trial

This is an interventional treatment trial for type1diabetes focused on measuring Uganda, type 1 diabetes, continuous glucose monitor, CGM, resource poor nations

Eligibility Criteria

4 Years - 26 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Libre 2

Libre Pro

Arm 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.

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.

Outcomes

Primary Outcome Measures

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)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05454176

First Posted

July 6, 2022

Last Updated

October 2, 2023

Sponsor

University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT05454176

Brief Title

Diabetes in African Youth

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 15, 2022 (Actual)

Primary Completion Date

August 15, 2027 (Anticipated)

Study Completion Date

August 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

type1diabetes

Keywords

Uganda, type 1 diabetes, continuous glucose monitor, CGM, resource poor nations

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

randomized, non-blinded, phase 4 clinical trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Libre 2

Arm Type

Active Comparator

Arm 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.

Arm Title

Libre Pro

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Libre 2

Intervention Description

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 <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.

Intervention Type

Device

Intervention Name(s)

Libre Pro

Intervention Description

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.

Primary Outcome Measure Information:

Title

Glucose Time-in-Range

Description

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)

Time Frame

1 year post enrollment

Title

Cost analysis of CGM

Description

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.

Time Frame

1 year post enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

26 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Beth Pappenfus

Phone

612-624-2922

papp0086@umn.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antoinette Moran

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Beth Pappenfus

Phone

612-624-2922

papp0086@umn.edu

12. IPD Sharing Statement

Learn more about this trial

Diabetes in African Youth

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