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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

867 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-08

Study Completion Date

2021-10-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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investigational group

Participants of the FUTURE study who switched during the study to Gla-300

Insulin Glargine 300 UNT/ML [Toujeo]

Intervention Type DRUG

Switch during standard routine care to Gla-300.

control group

Participants of the FUTURE study who did not switch to Insulin Gla-300

No interventions assigned to this group

Interventions

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Insulin Glargine 300 UNT/ML [Toujeo]

Switch during standard routine care to Gla-300.

Intervention Type DRUG

Eligibility Criteria

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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)

* 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®) 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

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No