Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03534544
Enrollment
362
Registered
2018-05-23
Start date
2018-08-23
Completion date
2019-12-17
Last updated
2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

artificial pancreas, pediatric, parents, adherence

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.

Interventions

None listed

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Joslin Diabetes Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
8 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Youth and parent preferences for automated insulin delivery systems1 daySemi-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

MeasureTime frameDescription
Diabetes burden1 dayProblem 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 hypoglycemia1 dayFear of Hypoglycemia survey - Worry Scale * 15 items * Possible score: 0-100 * Higher score indicates more worry about hypoglycemia
Diabetes acceptance1 dayAccepting Diabetes and Personal Treatment (ADAPT) survey * 24 items * Scoring methodology will be established with data from this study
Quality of life1 day5-Item World Health Organization (WHO-5) Well-Being Index * 5 items * Possible score: 0-100 (percentage score) * Higher score indicates better quality of life

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026