Status:
NOT_YET_RECRUITING
Assessing the Safety, Performance, and User Experience of the Tandem Mobi Automated Insulin Delivery System Among Young Competitive Athletes in Real-world Settings.
Lead Sponsor:
Rabin Medical Center
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
11-18 years
Phase:
NA
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 sys...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06979635
Start Date
June 1 2025
End Date
June 1 2025
Last Update
May 25 2025
Active Locations (1)
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1
Schneider Children's Medical Center of Israel
Petah Tikva, Israel, 4920235