Supporting Parents of Young Children With Type 1 Diabetes in Closed-Loop System
NCT ID: NCT03354286
Last Updated: 2019-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2017-11-07
2019-03-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
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Developmental & Technological Demands
Provide education on using diabetes technology in various settings and formats in this age group, and increase ability for real-time problem-solving. Identify and troubleshoot barriers to keeping young children in Auto Mode.
Developmental & Technological Demands
Education and training related to use of CGM in this age group
Distress Reduction
Identify and reduce parent distress symptoms and worries. Provide strategies for obtaining social support.
Distress Reduction
Education and training on reducing distress
Nutrition, Set Point, & C:I Ratio
Provide education on a variety of properties of food and how they affect blood glucose levels. Optimize the use of carbohydrate to Insulin ratios, insulin duration of action, and use of temporary target glucose set point in the 670G pump and the Quick bolus feature to gain better glycemic control.
Nutrition, Set Point, & C:I Ratio
Education and training on how to use the HCL system to dose for different kinds of foods to improve glycemic control
Hypoglycemia management
Focus on hypoglycemia management to avoid hyperglycemia, review fear of hypoglycemia
Hypoglycemia management
Education and training on reducing worries of hypoglycemia
Minimal Intervention
A short communication detailing the percentage of time spent in range and in Auto Mode and if the goals have been met.
Minimal Intervention
Minimal intervention to simulate standard care - serves as the control group
Interventions
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Developmental & Technological Demands
Education and training related to use of CGM in this age group
Distress Reduction
Education and training on reducing distress
Nutrition, Set Point, & C:I Ratio
Education and training on how to use the HCL system to dose for different kinds of foods to improve glycemic control
Hypoglycemia management
Education and training on reducing worries of hypoglycemia
Minimal Intervention
Minimal intervention to simulate standard care - serves as the control group
Eligibility Criteria
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Inclusion 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
2 Years
6 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
Indiana University
OTHER
Yale University
OTHER
University of South Florida
OTHER
Stanford University
OTHER
Responsible Party
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Bruce A. Buckingham
Professor, Department of Pediatrics, Endocrinology and Diabetes Division
Locations
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Stanford University School of Medicine
Palo Alto, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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43167
Identifier Type: -
Identifier Source: org_study_id
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