Type 1 Diabetes Mellitus, Type 1 Diabetes (T1D)
Conditions
Brief summary
The goal of this surveillance study is to collect real-world data on adults and youth with type 1 diabetes (T1D) using twiist(TM) for insulin delivery.
Interventions
DEVICEtwiist Automated Insulin Delivery System
twiist(TM) system includes a novel insulin pump, a CGM sensor, and the glycemic-control algorithm
Sponsors
Deka Research and Development
Jaeb Center for Health Research
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing and able to provide informed consent (or a parent or other legally authorized representative) * Age ≥ 6 years old * Diagnosis of T1D * Currently using twiist AID system, with initiation of twiist within 90 days of enrollment * Willing to only use an insulin approved for the pump * Residing in United States * Willing to use twiist in accordance with the user manual * Willing to have the study use the twiist data and any information that has been provided to Sequel Medtech, LLC or customer support since twiist was started * Willing to complete surveys at the beginning of the study and then monthly for 12 months * Willing to be contacted if clarification or further information is needed for any events reported on a survey or to customer support * Willing to provide medical records or sign a record release for any hospitalizations * Has cell service or if not, will have access to WIFI at least once a week * For females, not pregnant or planning pregnancy in the next 12 months * Able to speak and read English * Able to obtain documentation of HbA1c result obtained within 6 months prior to twiist initiation
Exclusion criteria
* Any form of diabetes other than T1D * Receiving dialysis for end-stage renal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severe hypoglycemia events | From enrollment to the end of participation at 12 months | Severe hypoglycemia events with cognitive impairment sufficient to require the assistance of a third party for treatment |
Secondary
| Measure | Time frame |
|---|---|
| Severe hypoglycemia events associated with seizure or loss of consciousness | From enrollment to the end of participation at 12 months |
| Diabetic ketoacidosis | From enrollment to the end of participation at 12 months |
| Hospitalizations related to use of twiist | From enrollment to the end of participation at 12 months |
| Unanticipated adverse device effects | From enrollment to the end of participation at 12 months |
Countries
United States
Outcome results
None listed