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

NCT05434559 | Completed FDA Drug

• 1 other identifier: S66239
• Study Type: observational
• Target: 475
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 1 Diabetes

Keywords

Insulin Degludec; Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• HbA1c

  12 months

• Time below 54 mg/dL

  12 months

• Time in range

  12 months

• Time below 70 mg/dL

  12 months

• Time above 180 mg/dL

  12 months

Other Outcomes (5)

• Hospital visits and/or admissions due to hypoglycemia or ketoacidosis

  12 months

• Participants who discontinue the use of Insulin Degludec

  12 months

• Reason for discontinuation of Insulin Degludec

  12 months

Study Arms (1)

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

Interventions

Insulin Degludec DRUG

Switch during standard routine care to Insulin Degludec.

Study cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• prof dr Pieter Gillard: lead
• University Hospital, Antwerp: collaborator

Study Sites (2)

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

Location

University Hospital Antwerp

Wilrijk, 2650, Belgium

Location

Related Publications (1)

• De Groote R, Lefever E, Charleer S, Donne P, De Block C, Mathieu C, Gillard P. Continuous Glucose Monitoring-Derived Glucometrics in Adults with Type 1 Diabetes When Switching Basal Insulins. Diabetes Technol Ther. 2024 Aug;26(8):587-595. doi: 10.1089/dia.2023.0616. Epub 2024 Apr 9.

  PMID: 38512387 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinating Investigator

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 28, 2022
• Study Start: February 20, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-12

Locations

BE (2)