Assessing the Safety, Performance, and User Experience of the Tandem Mobi Automated Insulin Delivery System Among Young Competitive Athletes in Real-world Settings.
NCT ID: NCT06979635
Last Updated: 2025-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
12 participants
INTERVENTIONAL
2025-06-30
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tandem Mobi Hybrid Closed Loop (HCL) pump
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
Tandem Mobi Hybrid Closed Loop (HCL) pump
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
Interventions
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Tandem Mobi Hybrid Closed Loop (HCL) pump
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
11 Years
18 Years
ALL
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Principal Investigators
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Marie Muller, MD
Role: PRINCIPAL_INVESTIGATOR
Schneider Children's Medical Center
Locations
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Schneider Children's Medical Center of Israel
Petah Tikva, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0800-24-RMC
Identifier Type: -
Identifier Source: org_study_id
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