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

NCT06979635 | Not Yet Recruiting FDA Device

• 1 other identifier: 0800-24-RMC
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes; Competitive athletes; Hybrid Closed Loop System

Outcome Measures

Primary Outcomes (1)

• Sensor glucose percentage of time in range (70-180 mg/dl)

  At the end of the 12 weeks intervention period

Secondary Outcomes (4)

• Percentage of sensor glucose readings <54 mg/dl

  At the end of the 12 weeks intervention period

• Percentage of sensor glucose readings >180 mg/dl

  At the end of the 12 weeks intervention period

• Percentage of sensor glucose readings >250 mg/dl

  At the end of the 12 weeks intervention period

• HbA1c

  At the end of the 12 weeks intervention period

Other Outcomes (10)

• Serious Adverse Events (SAE)

  At the end of the 12 weeks intervention period

• Diabetic Ketoacidosis (DKA) events

  At the end of the 12 weeks intervention period

• Severe Hypoglycemia events

  At the end of the 12 weeks intervention period

Study Arms (1)

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

Device: Tandem Mobi Hybrid Closed Loop (HCL) pump

Interventions

Tandem Mobi Hybrid Closed Loop (HCL) pump DEVICE

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

Tandem Mobi Hybrid Closed Loop (HCL) pump

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Type 1 diabetes (T1D) for at least 6 months
• ≤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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider Children's Medical Center of Israel

Petah Tikva, 4920235, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marie Muller, MD

  Schneider Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alona Hamou, Msc

CONTACT

972-545-950277; alonah@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 20, 2025
• Study Start: June 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

IL (1)