Glucose-lowering Drugs as an Adjunct to Insulin Therapy in Chinese Patients With Type 1 Diabetes

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: GLD+insulin group

Study type: Observational

Funder types: Other

Identifiers

NCT07415226

CCTR-2025C26

Details and patient eligibility

About

To assess the real-world impact of glucose-lowering drugs (GLDs) as an adjunct to insulin in Chinese patients with type 1 diabetes (T1DM).

Does glucose-lowering drugs (GLDs) as an adjunct to insulin improve clinical outcomes in Chinese patients with type 1 diabetes (T1DM) when used long-term in real-world practice?

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The research group consists of T1DM patients who first used oral hypoglycemic drugs from January 2013 to June 2024 and had a glycated hemoglobin level of >= 7%; The control group consisted of T1DM patients who maintained only insulin treatment regimen and had glycated hemoglobin >= 7%;
2. Age >= 18 years old;
3. At least one recorded HbA1c value before the start of treatment;
4. Maintain medication regimen as needed from baseline to at least 3 months;
5. Record the first glycated hemoglobin value after treatment.

Exclusion criteria

1. The patient had already used hypoglycemic drugs as an adjunct to insulin therapy before admission;
2. DKA、 Serious infection, perioperative status, severe trauma, pregnancy, patient's past or current involvement in interventional clinical research；
3. The standard for determining stress hyperglycemia by the supervising physician;
4. Patients who have no medication records or have not followed the treatment plan formulated by the doctor.

Trial design

500 participants in 2 patient groups

GLD+insulin group

Description:

Patients with insulin and additional glucose-lowering drugs to treat type 1 diabetes were identified as adjuvant medication users (GLD+insulin group).

Treatment:

Drug: GLD+insulin group

insulin-only group

Description:

Patients who did not use glucose-lowering drugs (GLDs) as an adjunct to treat type 1 diabetes in the datasets were identified as insulin-only users (insulin-only group)