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Continuous Glucose Monitoring

Continuous Glucose Monitoring for Type 1 Diabetes

Phase 4

Recruiting

Led By Antoinette Moran

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing whether continuous glucose monitoring will improve blood sugar control in children and young adults with type 1 diabetes in East Africa.

Who is the study for?

This trial is for children and young adults aged 4-26 in Uganda with Type 1 Diabetes (T1D) who have been managing their condition with insulin for at least a year. Participants need to have access to a cell phone, be able to visit the clinic monthly, and not be pregnant or planning pregnancy within a year. They must also not already own a CGM device.

What is being tested?

The study tests if using flash Continuous Glucose Monitoring (CGM) technology helps maintain blood sugar levels within the target range better than standard monitoring. Half of the participants will use FreeStyle Libre 2 CGM for real-time glucose tracking, while the other half will start with standard blood sugar testing before switching to CGM after six months.

What are the potential side effects?

Potential side effects from using CGMs like Libre may include skin irritation where the device attaches, inaccurate readings leading to incorrect insulin dosing, and possible discomfort during insertion of sensor.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am under 18 and have a parent or guardian to consent for me, or I am 18-26 and can consent for myself.

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I have been diagnosed with Type 1 Diabetes for at least a year.

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I am between 4 and 26 years old and live in Uganda.

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I am currently on insulin therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cost analysis of CGM

Glucose Time-in-Range

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Libre 2Experimental Treatment1 Intervention

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.

Group II: SMBG levels 3x/daily (standard diabetes management)Placebo Group1 Intervention

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.

0 / 4Eligibility criteria met