Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL: A FUTURE Substudy

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Insulin Glargine 300 UNT/ML [Toujeo]


Participation Criteria
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Eligibility Criteria
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Investigational group Inclusion Criteria: participant in the FUTURE study diagnosed with type 1 diabetes ≥3 months before start of the FUTURE study use of insulin pens for the entirety of the FUTURE study used Insulin Detemir (Levemir®), Insulin Glargine 100 U/mL (Lantus®) or an equivalent as basal insulin before switch to Gla-300 (Toujeo®) switched to Gla-300 (Toujeo®) during the FUTURE study for a sufficient amount of time (at least two consecutive diabetes consultations = 8 months) Exclusion Criteria: use of Fast-acting insulin aspart (Fiasp®) before or after switch to Gla-300 not using bolus insulin (only basal insulin) for women: pregnant or planning pregnancy during the FUTURE study Control group Inclusion Criteria: participant in the FUTURE study for at least 18 months diagnosed with type 1 diabetes ≥3 months before start of the FUTURE study use of insulin pens for the entirety of the FUTURE study use Insulin Detemir (Levemir®), Insulin Glargine 100 U/mL (Lantus®) or an equivalent as basal insulin during the entirety of the FUTURE study Exclusion Criteria: use of Fast-acting insulin aspart (Fiasp®) not using bolus insulin (only basal insulin) for women: pregnant or planning pregnancy during the FUTURE study switch to Gla-300 (Toujeo®) or Insulin Degludec (Tresiba®) before 18 months in FUTURE study (if switched after 18 months, only data up to switch to Gla-300 [Toujeo®] or Insulin Degludec [Tresiba®] will be used for this control participant)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| investigational group<br>Participants of the FUTURE study who switched during the study to Gla-300 | Drug: Insulin Glargine 300 UNT/ML [Toujeo]<br>* Switch during standard routine care to Gla-300.<br>|
| control group<br>Participants of the FUTURE study who did not switch to Insulin Gla-300 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin Glargine 300 U/mL, Continuous glucose monitoring