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

Not Applicable

Not yet recruiting

• Conditions: Type 1 Diabetes; Competitive Athletes; Hybrid Closed Loop System

• Registration Number: NCT06979635
• Lead Sponsor: Rabin Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Study Start: 2025-06
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sensor glucose percentage of time in range (70-180 mg/dl)	At the end of the 12 weeks intervention period

Secondary Outcome Measures

Name	Time	Method
Percentage of sensor glucose readings <54 mg/dl	At the end of the 12 weeks intervention period
Percentage of sensor glucose readings >180 mg/dl	At the end of the 12 weeks intervention period
Percentage of sensor glucose readings >250 mg/dl	At the end of the 12 weeks intervention period
HbA1c	At the end of the 12 weeks intervention period

Trial Locations

Locations (1)

Schneider Children's Medical Center of Israel; 🇮🇱 Petach-Tikva, Israel