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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03534544
• Other study ID #: CHS2018-05
• Secondary ID: DP3DK113511
• Status: Completed
• Start date: August 23, 2018
• Est. completion date: December 17, 2019

Study information

• Verified date: August 2021
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: December 17, 2019
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Joslin Diabetes Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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's All About Reducing Burden. Pediatr Diabetes. 2021 Jul 29. doi: 10.1111/pedi.13252. [Epub — View Citation

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. 2020 Dec 8:e14492. doi: 10.1111/dme.14492. [Epub ahead of pr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Worries about hypoglycemia	Fear of Hypoglycemia survey - Worry Scale; 15 items; Possible score: 0-100; Higher score indicates more worry about hypoglycemia	1 day
Secondary	Diabetes acceptance	Accepting Diabetes and Personal Treatment (ADAPT) survey; 24 items; Scoring methodology will be established with data from this study	1 day
Secondary	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