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

Clalit Health Services

Status: Not yet enrolling

Conditions: Type 1 Diabetes

Treatments: Device: Tandem Mobi Hybrid Closed Loop (HCL) pump

Study type: Interventional

Funder types: Other

Identifiers

NCT06979635

0800-24-RMC

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 11 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• Willing to switch to Tandem Mobi Pump System and Dexcom CGM for the study duration
• Competitive-level athletes

Exclusion criteria

• 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
• One or more episodes of ketoacidosis requiring hospitalization within 6 months prior to screening
• Individual has a positive pregnancy screening test

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Tandem Mobi Hybrid Closed Loop (HCL) pump

Experimental group

Description:

Tandem Mobi Hybrid Closed Loop (HCL) pump with an integrated Control-IQ algorithm (CIQ), the Dexcom G7 continuous glucose monitoring sensor (CGM ) and Tandem Mobi Mobile App

Treatment:

Device: Tandem Mobi Hybrid Closed Loop (HCL) pump