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NCT Number: NCT06979635

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schneider Children's Medical Center of Israel

Petah Tikva, 4920235, Israel

Location contact

Alona Hamou, MSc

CONTACT

[email protected]

972-3-9253282

Revital Nimri, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: At the end of the 12 weeks intervention period

Secondary outcomes

  1. Percentage of sensor glucose readings <54 mg/dl

    Time frame: At the end of the 12 weeks intervention period

  2. Percentage of sensor glucose readings >180 mg/dl

    Time frame: At the end of the 12 weeks intervention period

  3. Percentage of sensor glucose readings >250 mg/dl

    Time frame: At the end of the 12 weeks intervention period

  4. HbA1c

    Time frame: At the end of the 12 weeks intervention period

Other outcomes

  1. Serious Adverse Events (SAE)

    Time frame: At the end of the 12 weeks intervention period

  2. Diabetic Ketoacidosis (DKA) events

    Time frame: At the end of the 12 weeks intervention period

  3. Severe Hypoglycemia events

    Time frame: At the end of the 12 weeks intervention period

  4. Percentage of sensor glucose readings in the range 70 to 140 mg/dL

    Time frame: At the end of the 12 weeks intervention period

  5. Percentage of sensor glucose readings in the range 70 to 180 mg/dL

    Time frame: At the end of the 12 weeks intervention period

  6. Percentage of sensor glucose readings >180 mg/dL

    Time frame: At the end of the 12 weeks intervention period

  7. CGM derived indices- Mean glucose

    Time frame: At the end of the 12 weeks intervention period

  8. CGM derived indices: Coefficient of variation

    Time frame: At the end of the 12 weeks intervention period

  9. CGM derived indices: Peak glucose and change in glucose from the start of the meal to the peak (only calculated for post-meal periods)

    Time frame: At the end of the 12 weeks intervention period

  10. CGM derived indices: change in glucose from the start of the exercise to the nadir.

    Time frame: At the end of the 12 weeks intervention period

Study contacts

Contact information is provided by the study sponsor or research team.

Alona Hamou, Msc

CONTACT

[email protected]

972-545-950277

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Acronym: Captain MOBI

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 20, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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