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NCT05109520 | COMPLETED | Type 1 Diabetes

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
Sponsor:

prof dr Pieter Gillard

Information provided by (Responsible Party):

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.

Condition or disease

Type 1 Diabetes

Intervention/treatment

Insulin Glargine 300 UNT/ML [Toujeo]

Study Type : OBSERVATIONAL
Estimated Enrollment : 867 participants
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
Actual Study Start Date : 2021-09-08
Estimated Primary Completion Date : 2021-10-14
Estimated Study Completion Date : 2021-10-14

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
    • 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

    Location Details

    NCT05109520

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    Not yet recruiting

    Belgium,

    Our Lady Hospital Aalst

    Aalst, Belgium, 9300

    Not yet recruiting

    Belgium,

    Antwerp University Hospital

    Edegem, Belgium, 2650

    Not yet recruiting

    Belgium,

    University Hospitals Leuven

    Leuven, Belgium, 3000