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Assessing the Safety, Performance, and User Experience of the Tandem Mobi Automated Insulin Delivery System Among Young Competitive Athletes in Real-world Settings.

NCT06979635 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-05-25

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

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

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Marie Muller, MD · Schneider Children's Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
11 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2025-06-30
Completion
2025-06-30
FDA Device
Yes

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06979635 on ClinicalTrials.gov