Clinical trial NCT03534544: Patient and Parent Preferences for an On-Body Automated Insulin Delivery System
Official title: Patient and Parent Preferences for an On-Body Automated Insulin Delivery System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Keywords: artificial pancreas
pediatric
parents
adherence
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-05-23
Enrollment: 362
Sex: ALL
Minimum age (years): 8
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from the clinic populations of the 2 study sites.

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.

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

Primary outcomes:
measure: Youth and parent preferences for automated insulin delivery systems
timeFrame: 1 day
Secondary outcomes:
measure: Diabetes burden
timeFrame: 1 day
measure: Worries about hypoglycemia
timeFrame: 1 day
measure: Diabetes acceptance
timeFrame: 1 day
measure: Quality of life
timeFrame: 1 day
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: Lori Laffel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Stuart Weinzimer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard University
name: Eyal Dassau, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. 2021 Oct;38(10):e14492. doi: 10.1111/dme.14492. Epub 2021 Jan 20.
citation: 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.