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

NCT ID: NCT03534544

Last Updated: 2021-08-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 362 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-23
• Study Completion Date: 2019-12-17

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Joslin Diabetes Center

OTHER

Sponsor Role: lead

Responsible Party

Lori Laffel

Chief, Pediatric, Adolescent, and Young Adult Section; Co-Head, Section on Clinical, Behavioral and Outcomes Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lori Laffel, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Joslin Diabetes Center

Stuart Weinzimer, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Eyal Dassau, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard University

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Joslin Diabetes Center

Boston, Massachusetts, United States

Countries

United States

References

Commissariat PV, Volkening LK, Butler DA, Dassau E, Weinzimer SA, Laffel LM. Innovative features and functionalities of an artificial pancreas system: What do youth and parents want? Diabet Med. 2021 Oct;38(10):e14492. doi: 10.1111/dme.14492. Epub 2021 Jan 20.

Reference Type: RESULT

PMID: 33290599 (View on PubMed)

Commissariat PV, Roethke LC, Finnegan JL, Guo Z, Volkening LK, Butler DA, Dassau E, Weinzimer SA, Laffel LM. Youth and parent preferences for an ideal AP system: It is all about reducing burden. Pediatr Diabetes. 2021 Nov;22(7):1063-1070. doi: 10.1111/pedi.13252. Epub 2021 Aug 9.

Reference Type: RESULT

PMID: 34324772 (View on PubMed)

Other Identifiers

DP3DK113511

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHS2018-05

Identifier Type: -

Identifier Source: org_study_id