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Efficacy and safety of sodium-glucose cotransporter 2 inhibitors combined with insulin in children with type 1 diabetes: study protocol for a randomized controlled clinical trial

Efficacy and safety of sodium-glucose cotransporter 2 inhibitors combined with insulin in children with type 1 diabetes: study protocol for a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059035
Enrollment
Unknown
Registered
2022-04-23
Start date
2022-05-06
Completion date
Unknown
Last updated
2024-02-05

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

Conditions

Type 1 diabetes in children

Interventions

Treament group:Sodium-glucose cotransporter 2 inhibitors combined with insulin
Control:Insulin combined with other drugs

Sponsors

First Affiliated Hospital of Xinjiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Voluntary signing of informed consent; 2. Male or female subjects under the age of 18; 3. Subjects must have type 1 diabetes (clinical diagnosis) for more than 1 years. 4. Glycosylated hemoglobin < 10%; 5. The average daily dose of insulin pump (CSII) is 0.6-2.0 U/kg.

Exclusion criteria

Exclusion criteria: 1. Last HbA1c 70 mmol/mol; 2. Subject has celiac disease; 3. Daily average carbohydrate intake < 130 g/day from 14 days food record prior to the intervention; 4. Any concomitant disease possibly affecting glucose control; 5. Any chronic medication possibly affecting glucose control.

Design outcomes

Primary

MeasureTime frame
Fasting plasma glucose;Postprandial plasma glucose;Glycated hemoglobin A1C (HbA1c);Total daily insulin dosage;Incidence of adverse events;

Secondary

MeasureTime frame
Incidence of diabetic ketoacidosis;

Countries

China

Contacts

Public ContactMaimaiti·Mireguli

First Affiliated Hospital of Xinjiang Medical University

Milikita17@aliyun.com+86 15826478594

Outcome results

None listed

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