Type 1 Diabetes
Conditions
Keywords
Insulin Degludec, Continuous Glucose Monitoring
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.
Interventions
DRUGInsulin Degludec
Switch during standard routine care to Insulin Degludec.
Sponsors
University Hospital, Antwerp
prof dr Pieter Gillard
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in range | 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time below 70 mg/dL | 12 months | 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 |
| Time above 250 mg/dL | 12 months | 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 |
| Mean glucose | 12 months | 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 |
| Glycemic variability | 12 months | 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 |
| Insulin dose | 12 months | 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 |
| Body mass index | 12 months | difference in body mass index (BMI) between 12 \[±2\] months before switch to 12 \[±2\] months after switch to Insulin Degludec |
| HbA1c | 12 months | difference in HbA1c between 12 \[±2\] months before switch to 12 \[±2\] months after switch to Insulin Degludec |
| Time below 54 mg/dL | 12 months | 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 |
| Time in range | 12 months | 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 |
| Time above 180 mg/dL | 12 months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reason for discontinuation of Insulin Degludec | 12 months | overview of reasons to discontinue Insulin Degludec (in tabular view) |
| Indication for use of Insulin Degludec | baseline | overview of reasons to start Insulin Degludec (in tabular view) |
| Glycemic consensus targets | 12 months | proportion of people reaching HbA1c and glucose consensustargets 12 \[±2\] months after switch to Insulin Degludec |
| Participants who discontinue the use of Insulin Degludec | 12 months | number of participants who discontinue the use of Insulin Degludec |
| Hospital visits and/or admissions due to hypoglycemia or ketoacidosis | 12 months | 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 |
Countries
Belgium
Outcome results
None listed