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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Drug: Insulin Degludec

• Study Type: Observational
• Enrollment (Actual): 475

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuizen Leuven
  • Wilrijk, Belgium, 2650
    • University Hospital Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: Insulin Degludec; Switch during standard routine care to Insulin Degludec.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: prof dr Pieter Gillard
• Collaborators: University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2022
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring; Insulin Degludec
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: S66239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No