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

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Behavioral: Distress Reduction; Behavioral: Developmental & Technological Demands; Behavioral: Minimal Intervention; Behavioral: Hypoglycemia management

• Registration Number: NCT03354286
• Lead Sponsor: Stanford University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-07
• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-27
• Primary Completion: 2019-03-18
• Study Completion: 2019-03-18
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Distress Reduction	Distress Reduction	Identify and reduce parent distress symptoms and worries. Provide strategies for obtaining social support.
Developmental & Technological Demands	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.
Minimal Intervention	Minimal Intervention	A short communication detailing the percentage of time spent in range and in Auto Mode and if the goals have been met.
Hypoglycemia management	Hypoglycemia management	Focus on hypoglycemia management to avoid hyperglycemia, review fear of hypoglycemia

Primary Outcome Measures

Name	Time	Method
Time spent in blood glucose range	Change over 3 months	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

Name	Time	Method
Hemoglobin A1c	Change over 3 months	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	Change over 3 months	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.
State-Trait Anxiety Inventory	Change over 3 months	This is a widely used measure of anxiety symptoms. It is reported by the participant.
Parent Diabetes Distress Scale	Change over 3 months	This measure is widely used to capture the psychological distress experienced in relation to diabetes.
Patient Health Questionnaire 8	Change over 3 months	This is a widely used measure that captures depressive symptoms. It is reported by the participants.
Pittsburgh Sleep Quality Index	Change over 3 months	This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants.
Hypoglycemic Fear Survey - Parents	Change over 3 months	People with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants.
Hypoglycemia Confidence Questionnaire	Change over 3 months	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	Change over 3 months	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	Change over 3 months	This a measure used to capture overall satisfaction with glucose monitoring devices used by participants.
General and diabetes-specific technology use	Change over 3 months	This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices.
Health care utilization	Change over 3 months	Number of visits and calls to the diabetes care team.
Diabetes management behaviors	Change over 3 months	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.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Palo Alto, California, United States