Type 1 Diabetes
Conditions
Keywords
Insulin Glargine 300 U/mL, Continuous glucose monitoring
Brief summary
Retrospective multicenter study analyzing data gathered during the FUTURE study (S59342) to assess the effect of using Insulin Glargine 300 U/mL (Gla-300) on measures of diabetes control and quality of life. Of the FUTURE participants, data about the type of insulin the participants used will be gathered. On the basis of these data participants will be divided in two groups (control or investigational). Change in glycemic control and quality of life from before to after the switch to Gla-300 (investigational group) will be compared to the change of glycemic control and quality of life of the FUTURE participants who did not switch to Gla-300 (control group). The FUTURE study was a 24-month during multicenter observational cohort study analyzing data on the use of the Abbott Freestyle Libre in people with diabetes. Data were gathered during standard clinical follow-up, and from questionnaires that were presented to the participants at defined time points.
Interventions
Switch during standard routine care to Gla-300.
Sponsors
University Hospital, Antwerp
Onze Lieve Vrouw Hospital
prof dr Pieter Gillard
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Investigational group Inclusion Criteria: * participant in the FUTURE study * diagnosed with type 1 diabetes ≥3 months before start of the FUTURE study * use of insulin pens for the entirety of the FUTURE study * used Insulin Detemir (Levemir®), Insulin Glargine 100 U/mL (Lantus®) or an equivalent as basal insulin before switch to Gla-300 (Toujeo®) * switched to Gla-300 (Toujeo®) during the FUTURE study for a sufficient amount of time (at least two consecutive diabetes consultations = 8 months)
Exclusion criteria
* use of Fast-acting insulin aspart (Fiasp®) before or after switch to Gla-300 * not using bolus insulin (only basal insulin) * for women: pregnant or planning pregnancy during the FUTURE study 2. Control group Inclusion Criteria: * participant in the FUTURE study for at least 18 months * diagnosed with type 1 diabetes ≥3 months before start of the FUTURE study * use of insulin pens for the entirety of the FUTURE study * use Insulin Detemir (Levemir®), Insulin Glargine 100 U/mL (Lantus®) or an equivalent as basal insulin during the entirety of the FUTURE study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in range (TIR, 70-180 mg/dL) | maximum 24 months | The difference in evolution of TIR (70-180 mg/dL, averaged per month) over 24 hours since switch to Gla-300 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hyperglycemia | maximum 24 months | difference in time in hyperglycemia (\>180 mg/dL, \>250 mg/dL, \>180-≤250 mg/dL; averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am |
| Glycemic variability | maximum 24 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 |
| Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire | maximum 24 months | Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire (scale: 0 (low quality of life) - 100 (high quality of life)) |
| Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry | maximum 24 months | Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried)) |
| Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire | maximum 24 months | Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed)) |
| Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs) | maximum 24 months | Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs) (scale: 0 (low satisfaction) - 36 (high satisfaction)) |
| HbA1c | maximum 24 months | difference in HbA1c |
| Time in range (TIR, 70-180 mg/dL) | maximum 24 months | difference in TIR (70-180 mg/dL, averaged per month) from 6 am to 10 pm, and from 10 pm to 6 am |
| Hypoglycemia | maximum 24 months | difference in time in hypoglycemia (\<54 mg/dL, \<70 mg/dL, ≥54-\<70 mg/dL; averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am |
| Mean glycemia | maximum 24 months | difference in mean glucose (averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am |
Other
| Measure | Time frame | Description |
|---|---|---|
| Severe hypoglycemia rate | maximum 24 months | difference in self-reported severe hypoglycemic events |
| Hypoglycemic coma rate | maximum 24 months | difference in self-reported hypoglycemic comas |
| Hospitalization | maximum 24 months | difference in hospitalizations due to hypoglycemia or ketoacidosis |
| Body mass index | maximum 24 months | difference in body mass index (BMI) |
| Insulin dose | maximum 24 months | difference in insulin dose (basal, bolus and total) |
Countries
Belgium
Outcome results
None listed