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

Type 1 Diabetes Clinical Trial

— GLADE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05434559
• Other study ID #: S66239
• Status: Completed
• Start date: February 20, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: December 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 475
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Insulin Degludec
Switch during standard routine care to Insulin Degludec.

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven	Leuven
Belgium	University Hospital Antwerp	Wilrijk

Sponsors (2)

Lead Sponsor	Collaborator
prof dr Pieter Gillard	University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Participants who discontinue the use of Insulin Degludec	number of participants who discontinue the use of Insulin Degludec	12 months
Other	Reason for discontinuation of Insulin Degludec	overview of reasons to discontinue Insulin Degludec (in tabular view)	12 months
Other	Indication for use of Insulin Degludec	overview of reasons to start Insulin Degludec (in tabular view)	baseline
Other	Glycemic consensus targets	proportion of people reaching HbA1c and glucose consensustargets 12 [±2] months after switch to Insulin Degludec	12 months
Primary	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	HbA1c	difference in HbA1c between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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