Clinical trial NCT05109520: Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
Official title: Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL: A FUTURE Substudy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: Insulin Glargine 300 U/mL
Continuous glucose monitoring
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
name: Onze Lieve Vrouw Hospital
First posted: 2021-11-05
Enrollment: 867
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with type 1 diabetes who participated in the FUTURE study.

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.


Eligibility 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

Exclusion Criteria:

* use of Fast-acting insulin aspart (Fiasp®)
* not using bolus insulin (only basal insulin)
* for women: pregnant or planning pregnancy during the FUTURE study
* switch to Gla-300 (Toujeo®) or Insulin Degludec (Tresiba®) before 18 months in FUTURE study (if switched after 18 months, only data up to switch to Gla-300 \[Toujeo®\] or Insulin Degludec \[Tresiba®\] will be used for this control participant)

Primary outcomes:
measure: Time in range (TIR, 70-180 mg/dL)
timeFrame: maximum 24 months
Secondary outcomes:
measure: HbA1c
timeFrame: maximum 24 months
measure: Time in range (TIR, 70-180 mg/dL)
timeFrame: maximum 24 months
measure: Hypoglycemia
timeFrame: maximum 24 months
measure: Hyperglycemia
timeFrame: maximum 24 months
measure: Mean glycemia
timeFrame: maximum 24 months
measure: Glycemic variability
timeFrame: maximum 24 months
measure: Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire
timeFrame: maximum 24 months
measure: Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry
timeFrame: maximum 24 months
measure: Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire
timeFrame: maximum 24 months
measure: Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs)
timeFrame: maximum 24 months
Other outcomes:
measure: Insulin dose
timeFrame: maximum 24 months
measure: Body mass index
timeFrame: maximum 24 months
measure: Severe hypoglycemia rate
timeFrame: maximum 24 months
measure: Hypoglycemic coma rate
timeFrame: maximum 24 months
measure: Hospitalization
timeFrame: maximum 24 months
Locations:
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis Aalst
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Pieter Gillard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: