Assessing the Safety, Performance, and User Experience of the Tandem Mobi Automated Insulin Delivery System Among Young Competitive Athletes in Real-world Settings.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-18
SponsorRabin Medical Center

About this trial

A single arm, interventional study with 12 weeks study phase preceded by a 2-week run in phase, aiming to evaluate the effectiveness and applicability of the Tandem Mobi automated insulin delivery system (Tandem Mobi Pump System) for competitive youth athletes with type 1 diabetes in real-world conditions.

Eligibility criteria

Qualifiers

Type 1 diabetes (T1D) for at least 6 months

11≤Age≤18 years

HbA1c <10.0%

Current treatment with automated insulin delivery system (AID) or insulin pump for at least 1 month

Disqualifiers

Concomitant disease that influences metabolic control or HbA1c interpretation

Individual has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)

Use of antidiabetic agents other than insulin

Two or more episodes of severe hypoglycemia (hypoglycemia requiring treatment by another person) within the previous 6 months

Trial design

Treatments tested in this trial

  • Tandem Mobi Hybrid Closed Loop (HCL) pump

Treatment groups

12 Participants
are divided into 1 treatment group

Sponsors and collaborators