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Not yet recruiting NCT06979635

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

No phase Interventional Type 1 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tandem Mobi Hybrid Closed Loop (HCL) pump.
Who it may be relevant to
Registry conditions: Type 1 Diabetes. Basic parameters: 11 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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

Primary outcome measures

  • Sensor glucose percentage of time in range (70-180 mg/dl) [Time frame: At the end of the 12 weeks intervention period]
Secondary outcome measures (4)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Israel · 1 center
  • Schneider Children's Medical Center of Israel — Petah Tikva

Identifiers

NCT: NCT06979635 · 0800-24-RMC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗