Clinical trial NCT03354286: Supporting Parents of Young Children With Type 1 Diabetes in Closed-Loop System
Official title: Supporting Parents of Young Children With Type 1 Diabetes in Closed-Loop System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: 670G
Hybrid closed-loop system
pediatric
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: Indiana University
name: Yale University
name: University of South Florida
First posted: 2017-11-27
Enrollment: 26
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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: 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

Primary outcomes:
measure: Time spent in blood glucose range
timeFrame: Change over 3 months
Secondary outcomes:
measure: Hemoglobin A1c
timeFrame: Change over 3 months
measure: Problem Areas in Diabetes
timeFrame: Change over 3 months
measure: Parent Diabetes Distress Scale
timeFrame: Change over 3 months
measure: Patient Health Questionnaire 8
timeFrame: Change over 3 months
measure: State-Trait Anxiety Inventory
timeFrame: Change over 3 months
measure: Pittsburgh Sleep Quality Index
timeFrame: Change over 3 months
measure: Hypoglycemic Fear Survey - Parents
timeFrame: Change over 3 months
measure: Hypoglycemia Confidence Questionnaire
timeFrame: Change over 3 months
measure: Pediatric Quality of Life Inventory
timeFrame: Change over 3 months
measure: Glucose Monitoring System Satisfaction Survey
timeFrame: Change over 3 months
measure: General and diabetes-specific technology use
timeFrame: Change over 3 months
measure: Diabetes management behaviors
timeFrame: Change over 3 months
measure: Health care utilization
timeFrame: Change over 3 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
References: