Application of FreeStyle Libre 2 for Evaluating Glycemic Variability Characteristics in Patients With Extreme Glucose Metabolism Phenotypes

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorPeking University People's Hospital

About this trial

This cross-sectional study aims to further subdivide diabetes mellitus into more homogeneous subgroups by focusing on extreme glucose metabolism phenotypes, including monogenic diabetes with β cell dysfunction, hyperinsulinemia caused by excessive β cell secretion, and postprandial hypoglycemia phenotypes. By utilizing continuous glucose monitoring (CGM) technology and the FreeStyle Libre 2 glucose monitoring device, this study will evaluate glycemic variability patterns in patients with extreme glucose metabolism phenotypes and perform comparative analyses using existing CGM data from healthy populations and patients with type 2 diabetes in our center's database. The study aims to address current gaps in understanding glycemic variability characteristics under extreme β cell functional states, provide novel dynamic monitoring evidence to support early identification, precise classification, and personalized management of these special metabolic states, and simultaneously screen for biomarkers to enable more accurate disease identification, thereby offering potential avenues for improving personalized treatment of diabetes mellitus.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 18 years;

Patients with β cell dysfunction monogenic diabetes confirmed by DNA sequencing or other diagnostic testing.

Age ≥ 18 years;

Patients with confirmed type 2 diabetes mellitus;

Disqualifiers

Neonates younger than 4 months of age (congenital diabetes);

Pregnancy;

Patients with positive pancreatic autoantibody test results;

Patients with severe cardiovascular or cerebrovascular diseases, hepatic disease, or renal disease;

Trial population

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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 2 trial groups
Group A: Group A : diabetes mellitus group
Group B: Group B : normal glucose tolerance group

Trial outcomes

Primary outcomes

1

mean blood glucose in mmol/L

glycemic variability data

Time frame
The study is a cross-sectional study, patients wil wear a CGM for 14 days after enrollment, and will not wear it afterwards.
2

glucose management indicator (GMI) in %

glycemic variability data

Time frame
The study is a cross-sectional study, patients wil wear a CGM for 14 days after enrollment, and will not wear it afterwards.
3

highest glucose values in mmol/L

glycemic variability data

Time frame
The study is a cross-sectional study, patients wil wear a CGM for 14 days after enrollment, and will not wear it afterwards.
4

lowest glucose values in mmol/L

glycemic variability data

Time frame
The study is a cross-sectional study, patients wil wear a CGM for 14 days after enrollment, and will not wear it afterwards.

Secondary outcomes

1

weight in kilograms

weight and height will be combined to report BMI in kg/m\^2

Time frame
The study is a cross-sectional study, and the above indicators were measured only once at the initial enrollment.
2

height in meters

weight and height will be combined to report BMI in kg/m\^2

Time frame
The study is a cross-sectional study, and the above indicators were measured only once at the initial enrollment.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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