Clinical trial NCT05434559: Evaluation of Glycemic Control in Adults With Type 1 Diabetes When Switching to Insulin Degludec
Official title: Evaluation of Glycemic Control in Adults With Type 1 Diabetes When Switching to Insulin Degludec: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: Insulin Degludec
Continuous Glucose Monitoring
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
First posted: 2022-06-28
Enrollment: 475
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time in range
timeFrame: 12 months
Secondary outcomes:
measure: HbA1c
timeFrame: 12 months
measure: Time below 54 mg/dL
timeFrame: 12 months
measure: Time in range
timeFrame: 12 months
measure: Time below 70 mg/dL
timeFrame: 12 months
measure: Time above 180 mg/dL
timeFrame: 12 months
measure: Time above 250 mg/dL
timeFrame: 12 months
measure: Mean glucose
timeFrame: 12 months
measure: Glycemic variability
timeFrame: 12 months
measure: Insulin dose
timeFrame: 12 months
measure: Body mass index
timeFrame: 12 months
Other outcomes:
measure: Hospital visits and/or admissions due to hypoglycemia or ketoacidosis
timeFrame: 12 months
measure: Participants who discontinue the use of Insulin Degludec
timeFrame: 12 months
measure: Reason for discontinuation of Insulin Degludec
timeFrame: 12 months
measure: Indication for use of Insulin Degludec
timeFrame: baseline
measure: Glycemic consensus targets
timeFrame: 12 months
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
city: Wilrijk
country: Belgium
facility: University Hospital Antwerp
Study officials:
References: