Smart patch reveals hidden blood sugar patterns in rare diabetes
NCT ID NCT07564518
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study uses the FreeStyle Libre 2, a small sensor worn on the arm, to track blood sugar changes in 120 people with rare forms of diabetes, including monogenic diabetes and hyperinsulinemia. Researchers will compare these patterns with data from healthy people and those with type 2 diabetes. The goal is to better understand these extreme glucose metabolism states and improve diagnosis and personalized treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FreeStyle Libre 2 continuous glucose monitor
- What this could lead to
- If successful, this could help doctors better identify and treat rare forms of diabetes by understanding unique blood sugar patterns.
- What could go wrong
- This is an early observational study, not a treatment trial. It may not lead to immediate changes in care, and results may not apply to all diabetes patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
this study will use CGM to objectively and quantitatively compare glycemic variability parameters and patterns among four groups: patients with β cell dysfunction monogenic diabetes versus patients with type 2 diabetes mellitus, and patients with hyperinsulinemia versus healthy controls. This approach will reveal the effects of extreme β cell function on diurnal glycemic variability patterns and characterize distinctive dynamic glycemic profiles. 60 patients with β cell dysfunction monogenic diabetes and 60 patients with hyperinsulinemia and normal glucose tolerance who meet the inclusion criteria outlined will be recruited from the endocrinology outpatient clinic of our hospital. Groups A1 and A2, as well as Groups B1 and B2, will be matched at a 1:1 ratio by age, sex, and BMI. In addition, Groups A1 and A2 will be matched at a 1:1 ratio by HbA1c.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
1. Inclusion Criteria: 1. Group A1: * Age ≥ 18 years; * Patients with β cell dysfunction monogenic diabetes confirmed by DNA sequencing or other diagnostic testing. 2. Group A2: * Age ≥ 18 years; * Patients with confirmed type 2 diabetes mellitus; * Derived from this center's existing continuous glucose monitoring (CGM) database. 3. Group B1: * Age ≥ 18 years; * Normal fasting plasma glucose (≥ 3.6 and \< 6.1 mmol/L) and normal 2-hour plasma glucose during OGTT (≥ 3 and \< 7.8 mmol/L); * Fasting insulin ≥ 25 µU/mL and/or 2-hour insulin during OGTT greater than 10 times the fasting insulin level. 4. Group B2: * Age ≥ 18 years; * Normal glucose tolerance meeting the 2024 ADA criteria: fasting plasma glucose \< 5.6 mmol/L, 2-hour plasma glucose during OGTT \< 7.8 mmol/L; * According to laboratory reference standards, fasting insulin ≥ 2.6 and \< 25 µU/mL, and 2-hour insulin during OGTT 5-10 times the fasting insulin level. * Derived from this center's existing continuous glucose monitoring (CGM) database. 2. Exclusion Criteria: 1. Neonates younger than 4 months of age (congenital diabetes); 2. Pregnancy; 3. Patients with positive pancreatic autoantibody test results; 4. Patients with severe cardiovascular or cerebrovascular diseases, hepatic disease, or renal disease; 5. Patients who have participated in other clinical trials.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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