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

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: Insulin Degludec

• Registration Number: NCT05434559
• Lead Sponsor: prof dr Pieter Gillard

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-20
• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-21
• Study First Posted: 2022-06-28
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 475

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study cohort	Insulin Degludec	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

Primary Outcome Measures

Name	Time	Method
Time in range	12 months	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

Secondary Outcome Measures

Name	Time	Method
HbA1c	12 months	difference in HbA1c between 12 \[±2\] months before switch to 12 \[±2\] months after switch to Insulin Degludec
Glycemic variability	12 months	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
Time above 180 mg/dL	12 months	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
Time below 70 mg/dL	12 months	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
Mean glucose	12 months	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
Body mass index	12 months	difference in body mass index (BMI) between 12 \[±2\] months before switch to 12 \[±2\] months after switch to Insulin Degludec
Time below 54 mg/dL	12 months	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
Time in range	12 months	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
Time above 250 mg/dL	12 months	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
Insulin dose	12 months	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

Trial Locations

Locations (2)

University Hospital Antwerp; 🇧🇪 Wilrijk, Belgium

Universitaire Ziekenhuizen Leuven; 🇧🇪 Leuven, Belgium