Supporting Parents of Young Children With Type 1 Diabetes in Closed-Loop System
Status: | Active, not recruiting |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 2 - 6 |
Updated: | 4/6/2019 |
Start Date: | November 7, 2017 |
End Date: | April 30, 2020 |
This study will examine the impact of a closed-loop insulin delivery system intervention on
health and psychological outcomes in families with young children with Type 1 Diabetes (T1D).
health and psychological outcomes in families with young children with Type 1 Diabetes (T1D).
To be eligible for the study, a child must meet the following criteria since enrollment in
the CEP 302 Trial:
1. Diagnosis of type 1 diabetes according to ADA diagnostic criteria
2. Time since diagnosis of at least six months
3. Age between 2.00 and 6.99 years at enrollment
4. Parental consent to participate in the study
5. Completion of the CEP 302 Trial and in the continuation phase of the Medtronic CEP 302
Trial using the Medtronic MiniMed 670G pump with Enlite3 sensor.
To be eligible for the study, a parent must meet the following criteria:
1. Parent or legal guardian of a child with type 1 diabetes meeting the "child" criteria
outlined above.
2. Age of 18.0 years or older.
3. Parent comprehends written English.
4. Parent understands the study protocol and signs the informed consent document.
The presence of any of the following is an exclusion for the study (since enrollment in the
CEP 302 Trial):
1. Child has a medical disorder that in the judgment of the investigator will interfere
with completion of any aspect of the protocol (e.g., pregnancy, kidney disease,
adrenal insufficiency, skin condition that may hinder sensor application).
2. Child has a neurologic disorder that in the judgment of the investigator will affect
completion of the protocol
3. Current use of oral glucocorticoids or other medications, which in the judgment of the
investigator would be a contraindication to participation in the study
4. Child is unable to completely avoid acetaminophen for duration of study
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