Type 1 Diabetes Mellitus
Conditions
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?
Interventions
DRUGGLD+insulin group
The glucose-lowering drugs included in the analysis were metformin, acarbose and DPP-4i alone or in combination with other agents.
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 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
| Measure | Time frame |
|---|---|
| Absolute and relative insulin doses | Baseline to 3 months, 6 months, 12 months |
Outcome results
None listed