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

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ClinicalTrials.gov Identifier: NCT03534544
Recruitment Status : Recruiting
First Posted : May 23, 2018
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Lori Laffel, Joslin Diabetes Center

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.

Condition or disease
Diabetes Mellitus, Type 1

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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Patient and Parent Preferences for an On-Body Automated Insulin Delivery System
Actual Study Start Date : August 23, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited from the clinic populations of the 2 study sites.
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03534544


Contacts
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Contact: Lori Laffel, MD, MPH 617-732-2603 lori.laffel@joslin.harvard.edu

Locations
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United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Lori Carria    203-737-3595    lori.carria@yale.edu   
Principal Investigator: Stuart Weinzimer, MD         
United States, Massachusetts
Joslin Diabetes Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Lindsay Roethke    617-309-4477    lindsay.roethke@joslin.harvard.edu   
Principal Investigator: Lori Laffel, MD, MPH         
Sponsors and Collaborators
Joslin Diabetes Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Lori Laffel, MD, MPH Joslin Diabetes Center
Principal Investigator: Stuart Weinzimer, MD Yale University
Principal Investigator: Eyal Dassau, PhD Harvard University

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Responsible Party: Lori Laffel, Chief, Pediatric, Adolescent, and Young Adult Section; Co-Head, Section on Clinical, Behavioral and Outcomes Research, Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT03534544     History of Changes
Other Study ID Numbers: CHS2018-05
DP3DK113511 ( U.S. NIH Grant/Contract )
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Qualitative data may be available after removal of all personal identifiers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lori Laffel, Joslin Diabetes Center:
artificial pancreas
pediatric
parents
adherence

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases