Type 1 DiabetesCaptain MOBINCT06979635
Assessing the Safety, Performance, and User Experience of the Tandem Mobi Automated Insulin Delivery System Among Young Competitive Athletes in Real-world Settings.
A study testing Tandem Mobi Hybrid Closed Loop (HCL) pump in people with Type 1 Diabetes, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Tandem Mobi Hybrid Closed Loop (HCL) pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2025to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Schneider Children's Medical Center of Israel
Petah Tikva, 4920235
Alona Hamou, MSc, 972-3-9253282, alonah@clalit.org.il
Revital Nimri, MD
About this study
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.
- Conditions
- Type 1 Diabetes
- Being tested
- Tandem Mobi Hybrid Closed Loop (HCL) pump
- Keywords
- Type 1 Diabetes, Competitive athletes, Hybrid Closed Loop System
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tandem Mobi Hybrid Closed Loop (HCL) pumpDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Tandem Mobi Hybrid Closed Loop (HCL) pump | Experimental | 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 Receives: Device: Tandem Mobi Hybrid Closed Loop (HCL) pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensor glucose percentage of time in range (70-180 mg/dl)
Measured: At the end of the 12 weeks intervention period
Secondary outcomes (4)
Percentage of sensor glucose readings <54 mg/dl
Measured: At the end of the 12 weeks intervention period
Percentage of sensor glucose readings >180 mg/dl
Measured: At the end of the 12 weeks intervention period
Percentage of sensor glucose readings >250 mg/dl
Measured: At the end of the 12 weeks intervention period
HbA1c
Measured: At the end of the 12 weeks intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Muller, MD, Principal investigator, Schneider Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979635
- Sponsor's protocol ID
- 0800-24-RMC
- Acronym
- Captain MOBI
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Safety, Performance, and User Experience of the Tandem Mobi Automated Insulin Delivery System Among Young Competitive Athletes in Real-world Settings.
- ClinicalTrials.gov ID
- NCT06979635
- Acronym / sponsor ID
- Captain MOBI / 0800-24-RMC
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Competitive athletes, Hybrid Closed Loop System
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tandem Mobi Hybrid Closed Loop (HCL) pump | Experimental | Device: Tandem Mobi Hybrid Closed Loop (HCL) pumpTandem 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 |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tandem Mobi Hybrid Closed Loop (HCL) pumpTandem 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 | Device | Tandem Mobi Hybrid Closed Loop (HCL) pump |
Primary outcome
Sensor glucose percentage of time in range (70-180 mg/dl)
Time frame: At the end of the 12 weeks intervention period
4 secondary outcomes
Percentage of sensor glucose readings <54 mg/dl
Time frame: At the end of the 12 weeks intervention period
Percentage of sensor glucose readings >180 mg/dl
Time frame: At the end of the 12 weeks intervention period
Percentage of sensor glucose readings >250 mg/dl
Time frame: At the end of the 12 weeks intervention period
HbA1c
Time frame: At the end of the 12 weeks intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie Muller, MD principal investigator
Schneider Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tandem Mobi Hybrid Closed Loop (HCL) pump in people with Type 1 Diabetes, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alona Hamou, Msc (972-545-950277, alonah@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensor glucose percentage of time in range (70-180 mg/dl) (time frame: At the end of the 12 weeks intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.