NCT06979635Not 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.
Source: ClinicalTrials.gov · Last updated 25 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 13 May 2025
- Start date
- Jun 2025
- Primary completion date
- Jun 2025
- Lead sponsor
- Rabin Medical Center
- Diseases
- Type 1 diabetes
- NCT number
- NCT06979635
What you commit to
- Study type: Interventional
- Planned participants: 12
- From Jun 2025 to the primary completion date, Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Individual has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
Lab values
- Concomitant disease that influences metabolic control or HbA1c interpretation
Other
- Use of antidiabetic agents other than insulin
- Individual has a positive pregnancy screening test
Who the study is looking for
- 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
Age in the registry: 11 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Schneider Children's Medical Center of Israel Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.