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| Name | Class |
|---|---|
| University Hospital, Antwerp | OTHER |
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Retrospective multicenter study analyzing data gathered from medical records and diabetes management platforms to assess the effect of using Insulin Degludec (Tresiba®) on measures of diabetes control.
People with type 1 diabetes who switched to Insulin Degludec from another basal insulin between 1/5/2019 and 1/6/2021 will be included.
Glycemic control from 12 months before the switch to Insulin Degludec will be compared to glycemic control of the 12 months after the switch.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study cohort | People with type 1 diabetes who switched to Insulin Degludec from another basal insulin between 1/5/2019 and 1/6/2021 in the two participating sensors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Degludec | Drug | Switch during standard routine care to Insulin Degludec. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time in range | the change in time in range (TIR: 70-180 mg/dL, averaged per month) over 24 hours between 12 (±2) months before switch to 12 (±2) months after switch to Insulin Degludec | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | difference in HbA1c between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec | 12 months |
| Time below 54 mg/dL | difference in time in clinically significant hypoglycemia (<54 mg/dL averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital visits and/or admissions due to hypoglycemia or ketoacidosis | difference in number of hospital visits and/or admissions due to hypoglycemia or ketoacidosis between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec | 12 months |
| Participants who discontinue the use of Insulin Degludec |
Inclusion Criteria:
Exclusion Criteria:
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Every person who meet the inclusion criteria and who is/was followed at the two participating centers during the sampling period will be included in the analysis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaire Ziekenhuizen Leuven | Leuven | 3000 | Belgium | |||
| University Hospital Antwerp |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38512387 | Derived | De Groote R, Lefever E, Charleer S, Donne P, De Block C, Mathieu C, Gillard P. Continuous Glucose Monitoring-Derived Glucometrics in Adults with Type 1 Diabetes When Switching Basal Insulins. Diabetes Technol Ther. 2024 Aug;26(8):587-595. doi: 10.1089/dia.2023.0616. Epub 2024 Apr 9. |
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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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| ID | Term |
|---|---|
| C571886 | insulin degludec |
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| 12 months |
| Time in range | difference in TIR (70-180 mg/dL, averaged per month) from 6 am to 10 pm, and from 10 pm to 6 am between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec | 12 months |
| Time below 70 mg/dL | difference in time below range (<70 mg/dL averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec | 12 months |
| Time above 180 mg/dL | difference in time above range (>180 mg/dL averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec | 12 months |
| Time above 250 mg/dL | difference in time in significant hyperglycemia (>250 mg/dL averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec | 12 months |
| Mean glucose | difference in mean glucose (averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec | 12 months |
| Glycemic variability | difference in glycemic variability (standard deviation, coefficient of variation; averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec | 12 months |
| Insulin dose | difference in insulin dose (total daily dose, basal dose, bolus dose) between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec | 12 months |
| Body mass index | difference in body mass index (BMI) between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec | 12 months |
number of participants who discontinue the use of Insulin Degludec |
| 12 months |
| Reason for discontinuation of Insulin Degludec | overview of reasons to discontinue Insulin Degludec (in tabular view) | 12 months |
| Indication for use of Insulin Degludec | overview of reasons to start Insulin Degludec (in tabular view) | baseline |
| Glycemic consensus targets | proportion of people reaching HbA1c and glucose consensustargets 12 [±2] months after switch to Insulin Degludec | 12 months |
| Wilrijk |
| 2650 |
| Belgium |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |