Eligibility Module

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Eligibility Module

The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.

Eligibility Module path is as follows:

Study -> Protocol Section -> Eligibility Module

Eligibility Module

Ignite Creation Date: 2025-12-25 @ 4:19 AM
Ignite Modification Date: 2025-12-25 @ 4:19 AM
NCT ID: NCT05109520
Eligibility 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)
Healthy Volunteers: False
Sex: ALL
Minimum Age: 18 Years
Study: NCT05109520
Study Brief:
Protocol Section: NCT05109520