Patient and Parent Preferences for an On-Body Automated Insulin Delivery System

Completed

• Conditions: Diabetes Mellitus, Type 1

• Registration Number: NCT03534544
• Lead Sponsor: Joslin Diabetes Center

Brief Summary

The goal of this study is to learn more about patient and family preferences regarding use of advanced diabetes technologies. Young persons with type 1 diabetes (ages 8-25) and parents of young persons with type 1 diabetes will complete one study visit involving a semi-structured interview and surveys. The results of the study will be used to assist in the design of a new automated insulin delivery system.

Detailed Description

Type 1 diabetes remains the most common chronic disease of childhood and affects millions of children and adults globally. The minority of persons with type 1 diabetes achieve the recommended glycemic targets. Currently approved and unapproved automated insulin delivery systems require patients to carry and wear multiple devices (pumps, tubing, blood glucose meters, mobile devices, etc.). There is a need to design automated insulin delivery systems that reduce the burden of diabetes management for young persons and their families in an effort to improve glycemic control as well as other biomedical and psychosocial outcomes.

The purpose of this study is to conduct separate semi-structured interviews with young persons with type 1 diabetes and parents of youth with type 1 diabetes (not necessarily the parents of the youth participants) regarding their preferences for an automated, on-body insulin delivery system. Youth and parents will also complete short surveys related to perceived burden of diabetes self-care, quality of life, acceptance of diabetes, and worries about hypoglycemia. The feedback received from the interviews and surveys will help inform the design of a new on-body automated insulin delivery system.

Study Timeline

• Study First Submitted: 2018-04-20
• Study First Submitted QC: 2018-05-11
• Study First Posted: 2018-05-23
• Study Start: 2018-08-23
• Primary Completion: 2019-12-17
• Study Completion: 2019-12-17
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 362

Inclusion Criteria

• Young persons (ages 8-25 years) with type 1 diabetes for 1 year or longer
• Parents of young persons with type 1 diabetes

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Youth and parent preferences for automated insulin delivery systems	1 day	Semi-structured interviews with young persons with type 1 diabetes and parents; interviews will be transcribed and analyzed to derive central themes; this is a qualitative outcome

Secondary Outcome Measures

Name	Time	Method
Diabetes burden	1 day	Problem Areas in Diabetes survey - Pediatric version (PAID-Peds) and Parent revised version (PAID-PR); * PAID-Peds: 20 items, PAID-PR: 18 items; * Possible score: 0-100; * Higher score indicates more burden
Worries about hypoglycemia	1 day	Fear of Hypoglycemia survey - Worry Scale; * 15 items; * Possible score: 0-100; * Higher score indicates more worry about hypoglycemia
Diabetes acceptance	1 day	Accepting Diabetes and Personal Treatment (ADAPT) survey; * 24 items; * Scoring methodology will be established with data from this study
Quality of life	1 day	5-Item World Health Organization (WHO-5) Well-Being Index; * 5 items; * Possible score: 0-100 (percentage score); * Higher score indicates better quality of life

Trial Locations

Locations (2)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States