Evaluation of Glycemic Control in Adults With Type 1 Diabetes When Switching to Insulin Degludec

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Glycemic Control in Adults With Type 1 Diabetes When Switching to Insulin Degludec: a Retrospective Study

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Insulin Degludec


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People with T1D ≥18 years at the moment of switch to Insulin Degludec Diagnosed with T1D ≥2 years before switch to Insulin Degludec On basal-bolus insulin therapy with insulin pens ≥2 years before switch to Insulin Degludec ≥6 months use of Insulin Degludec at moment of datacollection Using continuous glucose monitoring ≥2 years before switch to Insulin Degludec Exclusion Criteria: People with T1D <18 years at the moment of switch to Insulin Degludec People without T1D or with T1D <2 years before switch to Insulin Degludec Women with T1D who are pregnant or planning pregnancy during -12 and +12 months Not using basal-bolus insulin therapy with insulin pens during -24 and +6 months Start to use non-insulin antidiabetic agents between -12 and +12 months Having received treatment with oral or injectable corticosteroids during -12 and +12 months Undergoing hemodialysis, renal transplantation, or beta cell transplantation during -12 and +12 months <6 months use of Insulin Degludec at moment of datacollection Not using continuous glucose monitoring or <2 years before switch to Insulin Degludec

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 |
| --- | --- |
| Study cohort<br>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 | Drug: Insulin Degludec<br>* Switch during standard routine care to Insulin Degludec.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin Degludec, Continuous Glucose Monitoring