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

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?

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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.

Primary outcomes

HbA1c

Time frame: Baseline to 3 months, 6 months, 12 months

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.

Secondary outcomes

Absolute and relative insulin doses

Time frame: Baseline to 3 months, 6 months, 12 months

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Effectiveness and Safety of Glucose-lowering Drugs as an Adjunct to Insulin Therapy in Chinese Patients With Type 1 Diabetes: a Retrospective, Observational Study

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Feb 17, 2026
Registry last updated: Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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