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NCT Number: NCT03534544

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

8 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale University School of Medicine, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Youth and parent preferences for automated insulin delivery systems

    Time frame: 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 outcomes

  1. Diabetes burden

    Time frame: 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

  2. Worries about hypoglycemia

    Time frame: 1 day

    Fear of Hypoglycemia survey - Worry Scale

    • 15 items
    • Possible score: 0-100
    • Higher score indicates more worry about hypoglycemia

  3. Diabetes acceptance

    Time frame: 1 day

    Accepting Diabetes and Personal Treatment (ADAPT) survey

    • 24 items
    • Scoring methodology will be established with data from this study

  4. Quality of life

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 23, 2018
Registry last updated
Aug 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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