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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute and relative insulin doses | Baseline to 3 months, 6 months, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |