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 (FUTURE-GLARE)

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Drug: Insulin Glargine 300 UNT/ML [Toujeo]

• Study Type: Observational
• Enrollment (Actual): 867

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • Onze Lieve Vrouw Ziekenhuis Aalst
  • Edegem, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuizen Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People with type 1 diabetes who participated in the FUTURE study.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
investigational group; Participants of the FUTURE study who switched during the study to Gla-300	Drug: Insulin Glargine 300 UNT/ML [Toujeo]; Switch during standard routine care to Gla-300.
control group; Participants of the FUTURE study who did not switch to Insulin Gla-300

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in range (TIR, 70-180 mg/dL)	The difference in evolution of TIR (70-180 mg/dL, averaged per month) over 24 hours since switch to Gla-300	maximum 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	difference in HbA1c	maximum 24 months
Time in range (TIR, 70-180 mg/dL)	difference in TIR (70-180 mg/dL, averaged per month) from 6 am to 10 pm, and from 10 pm to 6 am	maximum 24 months
Hypoglycemia	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	maximum 24 months
Hyperglycemia	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	maximum 24 months
Mean glycemia	difference in mean glucose (averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am	maximum 24 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	maximum 24 months
Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire	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))	maximum 24 months
Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry	Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried))	maximum 24 months
Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire	Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed))	maximum 24 months
Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs)	Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs) (scale: 0 (low satisfaction) - 36 (high satisfaction))	maximum 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin dose	difference in insulin dose (basal, bolus and total)	maximum 24 months
Body mass index	difference in body mass index (BMI)	maximum 24 months
Severe hypoglycemia rate	difference in self-reported severe hypoglycemic events	maximum 24 months
Hypoglycemic coma rate	difference in self-reported hypoglycemic comas	maximum 24 months
Hospitalization	difference in hospitalizations due to hypoglycemia or ketoacidosis	maximum 24 months

Collaborators and Investigators

• Sponsor: prof dr Pieter Gillard
• Collaborators: University Hospital, Antwerp; Onze Lieve Vrouw Hospital
• Investigators: Principal Investigator: Pieter Gillard, MD, PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2021
• Primary Completion (Actual): October 14, 2021
• Study Completion (Actual): October 14, 2021

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Continuous glucose monitoring; Insulin Glargine 300 U/mL
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Glargine
• Other Study ID Numbers: S65399

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: IPD can be shared upon a genuine request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No