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Efficacy and safety of different mealtime insulin dosing methods for glycemic control in type 1 diabetes adults treated with a closed-loop insulin pump

Efficacy and safety of different mealtime insulin dosing methods for glycemic control in type 1 diabetes adults treated with a closed-loop insulin pump

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066140
Enrollment
Unknown
Registered
2022-11-25
Start date
2022-11-25
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Type 1 diabetes

Interventions

Test group A:Insulin dosing algorithm, first carbohydrate counting, then fat-protein unit
Test group B:Insulin dosing algorithm, first fat-protein unit, then carbohydrate counting

Sponsors

First People's Hospital of Yunnan Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. The diagnosis of type 1 diabetes meets the 2019 ADA criteria; 2. Patients aged 18 and 45 with a medical history of more than one year; 3. Patients are undergoing MDI or CSII treatment for at least six months; 4. Glycated hemoglobin A1c (Hba1c) 7-11%; 5.Non-pregnant women.

Exclusion criteria

Exclusion criteria: 1. Severe hypoglycemia events (grade ? hypoglycemia: severe events without specific blood glucose boundaries, accompanied by changes in consciousness or body, hypoglycemia requiring help from others), ketoacidosis, or non-insulin anti-hyperglycemia drugs in the past six months; 2. Patients with gastroparesis, significant diabetic complications (glomerular filtration rate < 45 mL/min or already on dialysis); 3. Recent acute macrovascular events.

Design outcomes

Primary

MeasureTime frame
time above range, TAR;

Secondary

MeasureTime frame
time in range;glucose management indicator;time beyond range;

Countries

China

Contacts

Public ContactCai Yunying

First People's Hospital of Yunnan Province

maomao512@163.com+86 137 6916 5241

Outcome results

None listed

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