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Effectiveness of CGM based precision low-GI dietary intervention to reverse prediabetes in children/adolescents: a randomized controlled trial

Effectiveness of CGM based precision low-GI dietary intervention to reverse prediabetes in children/adolescents: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097555
Enrollment
Unknown
Registered
2025-02-20
Start date
2024-03-29
Completion date
Unknown
Last updated
2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Interventions

Regular diet group:A balanced diet
Low carb diet group:Low carb diet plan
Precision low GI diet group:Develop personalized and precise low GI diet plan based on CGM data

Sponsors

Children's Hospital, Zhejiang University School of Medicine, National Clinical Research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years

Inclusion criteria

Inclusion criteria: (1)10~18 years (2)According to the American Diabetes Association (ADA) guidelines, meeting the diagnostic criteria for prediabetes means, one or more of the following conditions: 1)5.6 mmol/L = FBG= 6.9 mmol/L; 2)7.8mmol/L = OGTT 2 hours glucose= 11.0 mmol/L; 3)5.7% = HbA1C= 6.4%.

Exclusion criteria

Exclusion criteria: Subjects will not be enrolled if they meet any of the following criteria: 1)Diagnosed diabetes (including type 1 diabetes, type 2 diabetes, and monogenic diabetes); 2)Hereditary obese children; 3)Serious medical (heart, liver, lung) diseases, malignant tumors; 4)Infectious disease (active stage) or receiving medication for acute disease; 5)Have used CGM currently or within the last 6 months; 6)People who can't cooperate.

Design outcomes

Primary

MeasureTime frame
Reversal rate of prediabetes at 24 weeks;

Secondary

MeasureTime frame
The level of HbA1c at 24 weeks;Fasting blood glucose at 24 weeks;Oral glucose tolerance test' 2 hours blood glucose at 24weeks;

Countries

China

Contacts

Public ContactJunfen Fu

Children's Hospital, Zhejiang University School of Medicine, National Clinical Research

fjf68@zju.edu.cn+86 137 7745 7849

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026