Supporting Parents of Young Children With Type 1 Diabetes in Closed-Loop System

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).

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Behavioral: Developmental & Technological Demands; Behavioral: Distress Reduction; Behavioral: Nutrition, Set Point, & C:I Ratio; Behavioral: Hypoglycemia management; Behavioral: Minimal Intervention

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Developmental & Technological Demands; Education and training related to use of CGM in this age group
Experimental: Distress Reduction; Identify and reduce parent distress symptoms and worries. Provide strategies for obtaining social support.	Behavioral: Distress Reduction; Education and training on reducing distress
Experimental: 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.	Behavioral: 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
Experimental: Hypoglycemia management; Focus on hypoglycemia management to avoid hyperglycemia, review fear of hypoglycemia	Behavioral: Hypoglycemia management; Education and training on reducing worries of hypoglycemia
Placebo Comparator: Minimal Intervention; A short communication detailing the percentage of time spent in range and in Auto Mode and if the goals have been met.	Behavioral: Minimal Intervention; Minimal intervention to simulate standard care - serves as the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change over 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change over 3 months
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.	Change over 3 months
Parent Diabetes Distress Scale	This measure is widely used to capture the psychological distress experienced in relation to diabetes.	Change over 3 months
Patient Health Questionnaire 8	This is a widely used measure that captures depressive symptoms. It is reported by the participants.	Change over 3 months
State-Trait Anxiety Inventory	This is a widely used measure of anxiety symptoms. It is reported by the participant.	Change over 3 months
Pittsburgh Sleep Quality Index	This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants.	Change over 3 months
Hypoglycemic Fear Survey - Parents	People with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants.	Change over 3 months
Hypoglycemia Confidence Questionnaire	Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations.	Change over 3 months
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.	Change over 3 months
Glucose Monitoring System Satisfaction Survey	This a measure used to capture overall satisfaction with glucose monitoring devices used by participants.	Change over 3 months
General and diabetes-specific technology use	This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices.	Change over 3 months
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.	Change over 3 months
Health care utilization	Number of visits and calls to the diabetes care team.	Change over 3 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: University of Colorado, Denver; University of South Florida; Yale University; Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2017
• Primary Completion (Actual): March 18, 2019
• Study Completion (Actual): March 18, 2019

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 27, 2017

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: pediatric; Hybrid closed-loop system; 670G
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 43167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No