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

NCT07415226 | Not Yet Recruiting

• 1 other identifier: CCTR-2025C26
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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?

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• HbA1c

  The primary outcome measure is glycated hemoglobin (HbA1c), which reflects the average blood glucose level of Chinese patients with type 1 diabetes mellitus (T1DM) over the past 2-3 months. HbA1c levels will be measured using a standardized clinical detection method at the baseline and follow-up visits of the study, to evaluate the long-term blood glucose control effect of insulin plus GLDs combined therapy compared with insulin monotherapy in real-world practice.

  Baseline to 3 months, 6 months, 12 months

Secondary Outcomes (1)

• Absolute and relative insulin doses

  Baseline to 3 months, 6 months, 12 months

Study Arms (2)

GLD+insulin group

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

Drug: GLD+insulin group

insulin-only group

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)

Interventions

GLD+insulin group DRUG

The glucose-lowering drugs included in the analysis were metformin, acarbose and DPP-4i alone or in combination with other agents.

GLD+insulin group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of Chinese adult patients with type 1 diabetes mellitus (T1DM) who met the predefined eligibility criteria, enrolled from January 2013 to June 2024. The population is divided into two cohorts: the study cohort (T1DM patients who first used oral GLDs as adjuvant therapy to insulin) and the control cohort (T1DM patients who maintained insulin monotherapy). All participants had an HbA1c level of ≥ 7% at baseline, were ≥ 18 years old, had at least one recorded HbA1c value before treatment initiation, and maintained the required medication regimen for at least 3 months. Patients with DKA, severe comorbidities, stress hyperglycemia, or incomplete medical records were excluded. This study population is representative of real-world T1DM patients with poor long-term blood glucose control who require adjuvant GLDs or maintain insulin monotherapy, ensuring the external validity of the study results.

You may qualify if:

• 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%;
• Age \>= 18 years old;
• At least one recorded HbA1c value before the start of treatment;
• Maintain medication regimen as needed from baseline to at least 3 months;
• Record the first glycated hemoglobin value after treatment.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph D

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02