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Clinical Trial Details

Trial ID: L5396
Source ID: NCT05434559
Associated Drug: Insulin Degludec
Title: Evaluation of Glycemic Control in Adults With Type 1 Diabetes When Switching to Insulin Degludec
Acronym: GLADE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes
Interventions: DRUG: Insulin Degludec
Outcome Measures: 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|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: 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
Sponsor/Collaborators: Sponsor: prof dr Pieter Gillard | Collaborators: University Hospital, Antwerp
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 475
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2022-02-20
Completion Date: 2022-10-31
Results First Posted:
Last Update Posted: 2022-12-21
Locations: Universitaire Ziekenhuizen Leuven, Leuven, 3000, Belgium|University Hospital Antwerp, Wilrijk, 2650, Belgium
URL: https://clinicaltrials.gov/show/NCT05434559