Status:
COMPLETED
Supporting Parents of Young Children With Type 1 Diabetes in Closed-Loop System
Lead Sponsor:
Stanford University
Collaborating Sponsors:
University of Colorado, Denver
Indiana University
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
2-6 years
Phase:
NA
Brief Summary
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).
Eligibility Criteria
Inclusion
- To be eligible for the study, a child must meet the following criteria since enrollment in the CEP 302 Trial:
- Diagnosis of type 1 diabetes according to ADA diagnostic criteria
- Time since diagnosis of at least six months
- Age between 2.00 and 6.99 years at enrollment
- Parental consent to participate in the study
- 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:
- Parent or legal guardian of a child with type 1 diabetes meeting the "child" criteria outlined above.
- Age of 18.0 years or older.
- Parent comprehends written English.
- 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):
- 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).
- Child has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol
- Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
- Child is unable to completely avoid acetaminophen for duration of study
Exclusion
Key Trial Info
Start Date :
November 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2019
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03354286
Start Date
November 7 2017
End Date
March 18 2019
Last Update
September 25 2019
Active Locations (1)
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1
Stanford University School of Medicine
Palo Alto, California, United States, 94304