Patient and Parent Preferences for an On-Body Automated Insulin Delivery System
2 other identifiers
observational
362
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2018
CompletedFirst Posted
Study publicly available on registry
May 23, 2018
CompletedStudy Start
First participant enrolled
August 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2019
CompletedAugust 10, 2021
August 1, 2021
1.3 years
April 20, 2018
August 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Diabetes burden
1 day
Worries about hypoglycemia
1 day
Diabetes acceptance
1 day
Quality of life
1 day
Eligibility Criteria
Participants will be recruited from the clinic populations of the 2 study sites.
You may qualify if:
- Young persons (ages 8-25 years) with type 1 diabetes for 1 year or longer
- Parents of young persons with type 1 diabetes
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Related Publications (2)
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.
PMID: 33290599RESULTCommissariat 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.
PMID: 34324772RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lori Laffel, MD, MPH
Joslin Diabetes Center
- PRINCIPAL INVESTIGATOR
Stuart Weinzimer, MD
Yale University
- PRINCIPAL INVESTIGATOR
Eyal Dassau, PhD
Harvard University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Pediatric, Adolescent, and Young Adult Section; Co-Head, Section on Clinical, Behavioral and Outcomes Research
Study Record Dates
First Submitted
April 20, 2018
First Posted
May 23, 2018
Study Start
August 23, 2018
Primary Completion
December 17, 2019
Study Completion
December 17, 2019
Last Updated
August 10, 2021
Record last verified: 2021-08