type1diabetesPhase 4NCT05454176
Diabetes in African Youth
A Phase 4 study testing Libre 2 and Device for SMBG and Libre Pro in people with type1diabetes, run by University of Minnesota at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 4 to 26 years
- Conditions the study is for
- type1diabetes
- What is being tested?
- Libre 2 and Device for SMBG and Libre Pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 15 Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Diabetes in African Youth: Improving Glucose Time-In-Range (DAYTime, Randomized Clinical Trial)
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.
Read more
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
- Being tested
- Libre 2, Device for SMBG and Libre Pro
- Keywords
- Uganda, type 1 diabetes, continuous glucose monitor, CGM, resource poor nations
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Libre 2Device
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 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.
Device for SMBG and Libre ProDevice
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 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 so as not to influence standard diabetes management. They will instead rely on SMBG values as per usual routine.
After the first 6 months they will receive Libre 2 CGM systems as described above for the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Libre 2 | Experimental | 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. Receives: Device: Libre 2 |
| SMBG levels 3x/daily (standard diabetes management) | Placebo comparator | 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. Receives: Device: Device for SMBG and Libre Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Time-in-Range
The change in glucose Time-in-Range (percent time glucose levels are 70-180 mg/dl) from baseline to six months will be compared between patients wearing the unblinded CGM to those performing standard 3x/day SMBG.
Measured: 6 months
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start15 Aug 2022
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, non-blinded, phase 4 clinical trial
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoinette Moran, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454176
- Sponsor's protocol ID
- PEDS-2022-31031
- Status last verified
- Oct 2026
- First submitted
- 6 Jul 2022
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes in African Youth: Improving Glucose Time-In-Range (DAYTime, Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05454176
- Acronym / sponsor ID
- PEDS-2022-31031
- Conditions
- type1diabetes
- Keywords
- Uganda, type 1 diabetes, continuous glucose monitor, CGM, resource poor nations
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, non-blinded, phase 4 clinical trial
| Arm | Type | Receives |
|---|---|---|
| Libre 2 | Experimental | Device: Libre 2Half 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. |
| SMBG levels 3x/daily (standard diabetes management) | Placebo comparator | Device: Device for SMBG and Libre ProHalf 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. |
Who may qualify
- Ages
- 4 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Libre 2The 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 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. | Device | Libre 2 |
| Device for SMBG and Libre ProA 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 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 so as not to influence standard diabetes management. They will instead rely on SMBG values as per usual routine. After the first 6 months they will receive Libre 2 CGM systems as described above for the intervention group. | Device | SMBG levels 3x/daily (standard diabetes management) |
Primary outcome
Glucose Time-in-Range
Time frame: 6 months
The change in glucose Time-in-Range (percent time glucose levels are 70-180 mg/dl) from baseline to six months will be compared between patients wearing the unblinded CGM to those performing standard 3x/day SMBG.
Cost analysis of CGM
Time frame: 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoinette Moran principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Libre 2 and Device for SMBG and Libre Pro in people with type1diabetes, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose Time-in-Range (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.