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

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: Insulin Glargine 300 UNT/ML [Toujeo]

• Registration Number: NCT05109520
• Lead Sponsor: prof dr Pieter Gillard

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-08
• Primary Completion: 2021-10-14
• Study Completion: 2021-10-14
• Study First Submitted: 2021-10-14
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-05
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 867

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
investigational group	Insulin Glargine 300 UNT/ML [Toujeo]	Participants of the FUTURE study who switched during the study to Gla-300

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
HbA1c	maximum 24 months	difference in HbA1c
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))
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
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
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
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))

Trial Locations

Locations (3)

Onze Lieve Vrouw Ziekenhuis Aalst; 🇧🇪 Aalst, Belgium

Universitaire Ziekenhuizen Leuven; 🇧🇪 Leuven, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium