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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 1

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Youth and parent preferences for automated insulin delivery systems | 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 | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes burden | 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 | 1 day | 
| Worries about hypoglycemia | Fear of Hypoglycemia survey - Worry Scale 15 items Possible score: 0-100 Higher score indicates more worry about hypoglycemia | 1 day | 
| Diabetes acceptance | Accepting Diabetes and Personal Treatment (ADAPT) survey 24 items Scoring methodology will be established with data from this study | 1 day | 
| Quality of life | 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 | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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artificial pancreas, pediatric, parents, adherence