Type 1 Diabetes
Conditions
Keywords
Type 1 Diabetes, Competitive athletes, Hybrid Closed Loop System
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.
Interventions
DEVICETandem 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
Rabin Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensor glucose percentage of time in range (70-180 mg/dl) | At the end of the 12 weeks intervention period |
Secondary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Percentage of sensor glucose readings >180 mg/dL | At the end of the 12 weeks intervention period |
| CGM derived indices- Mean glucose | At the end of the 12 weeks intervention period |
| Serious Adverse Events (SAE) | At the end of the 12 weeks intervention period |
| CGM derived indices: Peak glucose and change in glucose from the start of the meal to the peak (only calculated for post-meal periods) | At the end of the 12 weeks intervention period |
| CGM derived indices: change in glucose from the start of the exercise to the nadir. | At the end of the 12 weeks intervention period |
| CGM derived indices: Coefficient of variation | 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 |
| Percentage of sensor glucose readings in the range 70 to 140 mg/dL | At the end of the 12 weeks intervention period |
| Percentage of sensor glucose readings in the range 70 to 180 mg/dL | At the end of the 12 weeks intervention period |
Countries
Israel
Contacts
Primary ContactAlona Hamou, Msc
Outcome results
None listed