Tests an automated insulin pump in young athletes with type 1 diabetes
Tests an automated insulin pump system in young competitive athletes with type 1 diabetes.
Plain-language title generated from the registry record
Registry title: Assessing the Safety, Performance, and User Experience of the Tandem Mobi Automated Insulin Delivery System Among Young Competitive Athletes in Real-world Settings.
Key facts
- Where
- Petah Tikva, IsraelSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 11 and 18 years old?
Source: NCT06979635, who can take part
Where in Israel
- Schneider Children's Medical Center of IsraelPetah Tikva, IsraelNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Rabin Medical Center
- Trial code
- NCT06979635
- Record updated
- 25 May 2025
- Original description
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.Read full original descriptionShow less
Assessing the Safety, Performance, and User Experience of the Tandem Mobi Automated Insulin Delivery System Among Young Competitive Athletes in Real-world Settings.
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.
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: 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 any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection); Concomitant disease that influences metabolic control or HbA1c interpretation; Use of antidiabetic agents other than insulin; Individual has a positive pregnancy screening test.