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| Name | Class |
|---|---|
| University Hospital, Antwerp | OTHER |
| Onze Lieve Vrouw Hospital | OTHER |
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Retrospective multicenter study analyzing data gathered during the FUTURE study (S59342) to assess the effect of using Insulin Glargine 300 U/mL (Gla-300) on measures of diabetes control and quality of life.
Of the FUTURE participants, data about the type of insulin the participants used will be gathered. On the basis of these data participants will be divided in two groups (control or investigational).
Change in glycemic control and quality of life from before to after the switch to Gla-300 (investigational group) will be compared to the change of glycemic control and quality of life of the FUTURE participants who did not switch to Gla-300 (control group).
The FUTURE study was a 24-month during multicenter observational cohort study analyzing data on the use of the Abbott Freestyle Libre in people with diabetes. Data were gathered during standard clinical follow-up, and from questionnaires that were presented to the participants at defined time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| investigational group | Participants of the FUTURE study who switched during the study to Gla-300 |
| |
| control group | Participants of the FUTURE study who did not switch to Insulin Gla-300 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glargine 300 UNT/ML [Toujeo] | Drug | Switch during standard routine care to Gla-300. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time in range (TIR, 70-180 mg/dL) | The difference in evolution of TIR (70-180 mg/dL, averaged per month) over 24 hours since switch to Gla-300 | maximum 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | difference in HbA1c | maximum 24 months |
| Time in range (TIR, 70-180 mg/dL) | difference in TIR (70-180 mg/dL, averaged per month) from 6 am to 10 pm, and from 10 pm to 6 am |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin dose | difference in insulin dose (basal, bolus and total) | maximum 24 months |
| Body mass index | difference in body mass index (BMI) | maximum 24 months |
Investigational group
Inclusion Criteria:
Exclusion Criteria:
Control group
Inclusion Criteria:
Exclusion Criteria:
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People with type 1 diabetes who participated in the FUTURE study.
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| Name | Affiliation | Role |
|---|---|---|
| Pieter Gillard, MD, PhD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onze Lieve Vrouw Ziekenhuis Aalst | Aalst | 9300 | Belgium | |||
| Universitair Ziekenhuis Antwerpen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38386438 | Derived | Charleer S, Fieuws S, De Block C, Bolsens N, Nobels F, Mikkelsen K, Mathieu C, Gillard P. Evaluation of Glucose Metrics in Adults with Type 1 Diabetes Switching to Insulin Glargine 300 U/mL: A Retrospective, Propensity-Score Matched Study. Diabetes Technol Ther. 2024 Jul;26(7):488-493. doi: 10.1089/dia.2023.0371. Epub 2024 Mar 6. |
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IPD can be shared upon a genuine request.
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| maximum 24 months |
| Hypoglycemia | difference in time in hypoglycemia (<54 mg/dL, <70 mg/dL, ≥54-<70 mg/dL; averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am | maximum 24 months |
| Hyperglycemia | difference in time in hyperglycemia (>180 mg/dL, >250 mg/dL, >180-≤250 mg/dL; averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am | maximum 24 months |
| Mean glycemia | difference in mean glucose (averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am | maximum 24 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 | maximum 24 months |
| Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire | Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire (scale: 0 (low quality of life) - 100 (high quality of life)) | maximum 24 months |
| Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry | Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried)) | maximum 24 months |
| Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire | Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed)) | maximum 24 months |
| Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs) | Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs) (scale: 0 (low satisfaction) - 36 (high satisfaction)) | maximum 24 months |
| Severe hypoglycemia rate | difference in self-reported severe hypoglycemic events | maximum 24 months |
| Hypoglycemic coma rate | difference in self-reported hypoglycemic comas | maximum 24 months |
| Hospitalization | difference in hospitalizations due to hypoglycemia or ketoacidosis | maximum 24 months |
| Edegem |
| 2650 |
| Belgium |
| Universitaire Ziekenhuizen Leuven | Leuven | 3000 | Belgium |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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