Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Behavioral: No intervention; Behavioral: Developmental Demands; Behavioral: Distress Reduction; Behavioral: Fear of Hypoglycemia; Behavioral: Remote Monitoring

• Registration Number: NCT02848261
• Lead Sponsor: Stanford University

Brief Summary

The primary objective of this project is to examine the impact of a continuous glucose monitoring (CGM) intervention on health and psychological outcomes in young children with type 1 diabetes (T1D).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-07-25
• Study First Posted: 2016-07-28
• Study Start: 2016-08-15
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-07
• Last Update Posted: 2019-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
No Intervention	No intervention	Serves as the control group comparator. No intervention provided.
Developmental Demands	Developmental Demands	Provide education on using diabetes technology in various settings and formats in this age group, and increase ability for real-time problem-solving.
Distress Reduction	Distress Reduction	Identify and reduce parent distress symptoms and worries. Provide strategies for obtaining social support.
Fear of Hypoglycemia	Fear of Hypoglycemia	Decrease fear of hypoglycemia, particularly focusing on overnight glycemic control.
Remote Monitoring	Remote Monitoring	Optimize the use of remote monitoring by focusing on situational demands and problem solving.

Primary Outcome Measures

Name	Time	Method
Time spent in blood glucose range	Change over 6 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.
Pediatric Quality of Life Inventory	Change over 6 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.

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index	Change over 6 months	This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants.
A1c	Change over 6 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.
Diabetes Distress Scale	Change over 6 months	This measure is widely used to capture the psychological distress experienced in relation to diabetes.
Patient Health Questionnaire 9	Change over 6 months	This is a widely used measure that captures depressive symptoms. It is reported by the participants.
Problem Areas in Diabetes	Change over 6 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 6 months	This is a widely used measure of anxiety symptoms. It is reported by the participant.
General and diabetes-specific technology use	Change over 6 months	This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices.
Hypoglycemic Fear Survey	Change over 6 months	People with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants.
Hypoglycemic Confidence Questionnaire	Change over 6 months	Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations.
Glucose Monitoring System Satisfaction Survey	Change over 6 months	This a measure used to capture overall satisfaction with glucose monitoring devices used by participants.

Trial Locations

Locations (4)

Stanford University; 🇺🇸 Stanford, California, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States