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

Type 1 Diabetes Clinical Trial

— FUTURE-GLARE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05109520
• Other study ID #: S65399
• Status: Completed
• Start date: September 8, 2021
• Est. completion date: October 14, 2021

Study information

• Verified date: August 2022
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 867
• Est. completion date: October 14, 2021
• Est. primary completion date: October 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Insulin Glargine 300 UNT/ML [Toujeo]
Switch during standard routine care to Gla-300.

Locations

Country	Name	City	State
Belgium	Onze Lieve Vrouw Ziekenhuis Aalst	Aalst
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Universitaire Ziekenhuizen Leuven	Leuven

Sponsors (3)

Lead Sponsor	Collaborator
prof dr Pieter Gillard	Onze Lieve Vrouw Hospital, University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Insulin dose	difference in insulin dose (basal, bolus and total)	maximum 24 months
Other	Body mass index	difference in body mass index (BMI)	maximum 24 months
Other	Severe hypoglycemia rate	difference in self-reported severe hypoglycemic events	maximum 24 months
Other	Hypoglycemic coma rate	difference in self-reported hypoglycemic comas	maximum 24 months
Other	Hospitalization	difference in hospitalizations due to hypoglycemia or ketoacidosis	maximum 24 months
Primary	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	HbA1c	difference in HbA1c	maximum 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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