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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.

ConditionType 1 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-18
SponsorRabin Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Tandem Mobi Hybrid Closed Loop (HCL) pumpExperimental treatment 1 intervention

Trial outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rabin Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: