Clinical trial NCT06979635: Assessing the Safety, Performance, and User Experience of the Tandem Mobi Automated Insulin Delivery System Among Young Competitive Athletes in Real-world Settings.
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes
Competitive athletes
Hybrid Closed Loop System
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 12
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 system (Tandem Mobi Pump System) for competitive youth athletes with type 1 diabetes in real-world conditions.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Sensor glucose percentage of time in range (70-180 mg/dl)
timeFrame: At the end of the 12 weeks intervention period
Secondary outcomes:
measure: Percentage of sensor glucose readings <54 mg/dl
timeFrame: At the end of the 12 weeks intervention period
measure: Percentage of sensor glucose readings >180 mg/dl
timeFrame: At the end of the 12 weeks intervention period
measure: Percentage of sensor glucose readings >250 mg/dl
timeFrame: At the end of the 12 weeks intervention period
measure: HbA1c
timeFrame: At the end of the 12 weeks intervention period
Other outcomes:
measure: Serious Adverse Events (SAE)
timeFrame: At the end of the 12 weeks intervention period
measure: Diabetic Ketoacidosis (DKA) events
timeFrame: At the end of the 12 weeks intervention period
measure: Severe Hypoglycemia events
timeFrame: At the end of the 12 weeks intervention period
measure: Percentage of sensor glucose readings in the range 70 to 140 mg/dL
timeFrame: At the end of the 12 weeks intervention period
measure: Percentage of sensor glucose readings in the range 70 to 180 mg/dL
timeFrame: At the end of the 12 weeks intervention period
measure: Percentage of sensor glucose readings >180 mg/dL
timeFrame: At the end of the 12 weeks intervention period
measure: CGM derived indices- Mean glucose
timeFrame: At the end of the 12 weeks intervention period
measure: CGM derived indices: Coefficient of variation
timeFrame: At the end of the 12 weeks intervention period
measure: CGM derived indices: Peak glucose and change in glucose from the start of the meal to the peak (only calculated for post-meal periods)
timeFrame: At the end of the 12 weeks intervention period
measure: CGM derived indices: change in glucose from the start of the exercise to the nadir.
timeFrame: At the end of the 12 weeks intervention period
Locations:
city: Petach-Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
affiliation: Schneider Children's Medical Center
name: Marie Muller, MD
role: PRINCIPAL_INVESTIGATOR
References: