Back to resultsSupporting Parents of Young Children With Type 1 Diabetes in Closed-Loop System
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Developmental & Technological Demands
Distress Reduction
Nutrition, Set Point, & C:I Ratio
Hypoglycemia management
Minimal Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Type 1 Diabetes Mellitus focused on measuring 670G, Hybrid closed-loop system, pediatric
Eligibility Criteria
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
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Developmental & Technological Demands
Distress Reduction
Nutrition, Set Point, & C:I Ratio
Hypoglycemia management
Minimal Intervention
Arm Description
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.
Identify and reduce parent distress symptoms and worries. Provide strategies for obtaining social support.
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.
Focus on hypoglycemia management to avoid hyperglycemia, review fear of hypoglycemia
A short communication detailing the percentage of time spent in range and in Auto Mode and if the goals have been met.
Outcomes
Primary Outcome Measures
Time spent in blood glucose range
Increasingly it is recognized that the percent time spent in a target blood glucose range, which is set by the American Diabetes Association, is an important outcome. This measure will be used as a primary outcome and derived from objective data downloads.
Secondary Outcome Measures
Hemoglobin A1c
The hemoglobin A1c value is a biologic measure of the glycemia that is the gold standard measure of "control" of diabetes. Collected through a blood sample.
Problem Areas in Diabetes
This measure captures areas that are reported as problems for people with diabetes. Participants in the study report on daily problems with diabetes via this measure.
Parent Diabetes Distress Scale
This measure is widely used to capture the psychological distress experienced in relation to diabetes.
Patient Health Questionnaire 8
This is a widely used measure that captures depressive symptoms. It is reported by the participants.
State-Trait Anxiety Inventory
This is a widely used measure of anxiety symptoms. It is reported by the participant.
Pittsburgh Sleep Quality Index
This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants.
Hypoglycemic Fear Survey - Parents
People with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants.
Hypoglycemia Confidence Questionnaire
Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations.
Pediatric Quality of Life Inventory
This is a measure of health-related quality of life. It is used to understand the broader impact on quality of life which includes social, psychological, and health aspects of daily living.
Glucose Monitoring System Satisfaction Survey
This a measure used to capture overall satisfaction with glucose monitoring devices used by participants.
General and diabetes-specific technology use
This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices.
Diabetes management behaviors
Amount of time spent in Auto Mode; blood glucose monitoring frequency (by meter download); adherence to pump boluses. It is objectively reported by device downloads.
Health care utilization
Number of visits and calls to the diabetes care team.
Full Information
NCT ID
NCT03354286
First Posted
November 21, 2017
Last Updated
September 24, 2019
Sponsor
Stanford University
Collaborators
University of Colorado, Denver, Indiana University, Yale University, University of South Florida
1. Study Identification
Unique Protocol Identification Number
NCT03354286
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 7, 2017 (Actual)
Primary Completion Date
March 18, 2019 (Actual)
Study Completion Date
March 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
University of Colorado, Denver, Indiana University, Yale University, University of South Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
670G, Hybrid closed-loop system, pediatric
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Developmental & Technological Demands
Arm Type
Experimental
Arm Description
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.
Arm Title
Distress Reduction
Arm Type
Experimental
Arm Description
Identify and reduce parent distress symptoms and worries. Provide strategies for obtaining social support.
Arm Title
Nutrition, Set Point, & C:I Ratio
Arm Type
Experimental
Arm Description
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.
Arm Title
Hypoglycemia management
Arm Type
Experimental
Arm Description
Focus on hypoglycemia management to avoid hyperglycemia, review fear of hypoglycemia
Arm Title
Minimal Intervention
Arm Type
Placebo Comparator
Arm Description
A short communication detailing the percentage of time spent in range and in Auto Mode and if the goals have been met.
Intervention Type
Behavioral
Intervention Name(s)
Developmental & Technological Demands
Intervention Description
Education and training related to use of CGM in this age group
Intervention Type
Behavioral
Intervention Name(s)
Distress Reduction
Intervention Description
Education and training on reducing distress
Intervention Type
Behavioral
Intervention Name(s)
Nutrition, Set Point, & C:I Ratio
Intervention Description
Education and training on how to use the HCL system to dose for different kinds of foods to improve glycemic control
Intervention Type
Behavioral
Intervention Name(s)
Hypoglycemia management
Intervention Description
Education and training on reducing worries of hypoglycemia
Intervention Type
Behavioral
Intervention Name(s)
Minimal Intervention
Intervention Description
Minimal intervention to simulate standard care - serves as the control group
Primary Outcome Measure Information:
Title
Time spent in blood glucose range
Description
Increasingly it is recognized that the percent time spent in a target blood glucose range, which is set by the American Diabetes Association, is an important outcome. This measure will be used as a primary outcome and derived from objective data downloads.
Time Frame
Change over 3 months
Secondary Outcome Measure Information:
Title
Hemoglobin A1c
Description
The hemoglobin A1c value is a biologic measure of the glycemia that is the gold standard measure of "control" of diabetes. Collected through a blood sample.
Time Frame
Change over 3 months
Title
Problem Areas in Diabetes
Description
This measure captures areas that are reported as problems for people with diabetes. Participants in the study report on daily problems with diabetes via this measure.
Time Frame
Change over 3 months
Title
Parent Diabetes Distress Scale
Description
This measure is widely used to capture the psychological distress experienced in relation to diabetes.
Time Frame
Change over 3 months
Title
Patient Health Questionnaire 8
Description
This is a widely used measure that captures depressive symptoms. It is reported by the participants.
Time Frame
Change over 3 months
Title
State-Trait Anxiety Inventory
Description
This is a widely used measure of anxiety symptoms. It is reported by the participant.
Time Frame
Change over 3 months
Title
Pittsburgh Sleep Quality Index
Description
This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants.
Time Frame
Change over 3 months
Title
Hypoglycemic Fear Survey - Parents
Description
People with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants.
Time Frame
Change over 3 months
Title
Hypoglycemia Confidence Questionnaire
Description
Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations.
Time Frame
Change over 3 months
Title
Pediatric Quality of Life Inventory
Description
This is a measure of health-related quality of life. It is used to understand the broader impact on quality of life which includes social, psychological, and health aspects of daily living.
Time Frame
Change over 3 months
Title
Glucose Monitoring System Satisfaction Survey
Description
This a measure used to capture overall satisfaction with glucose monitoring devices used by participants.
Time Frame
Change over 3 months
Title
General and diabetes-specific technology use
Description
This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices.
Time Frame
Change over 3 months
Title
Diabetes management behaviors
Description
Amount of time spent in Auto Mode; blood glucose monitoring frequency (by meter download); adherence to pump boluses. It is objectively reported by device downloads.
Time Frame
Change over 3 months
Title
Health care utilization
Description
Number of visits and calls to the diabetes care team.
Time Frame
Change over 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Supporting Parents of Young Children With Type 1 Diabetes in Closed-Loop System
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