Green Digital Diabetes Waste Project

Sponsor
Florida State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06071325
Collaborator
Diabetes Technology Society (Other)
40
2
7.4
20
2.7

Study Details

Study Description

Brief Summary

The purpose of this study is to determine how people with diabetes are disposing of various products and devices and at what rates so that better devices with less waste can be designed in the future.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study aims to compare the amount of environmental waste that is generated during the management of diabetes of participants who are using a CGM and on multiple daily injection (MDI) or using an AID (automated insulin delivery) system. This study is expected to demonstrate which devices create the most waste and where opportunities exist to decrease diabetes device waste. We will collect data to describe both quantitatively (via daily survey) and qualitatively (via photography) the types of waste that are generated during the management of diabetes.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Green Digital Diabetes Waste Project: Quantifying the Amount of Environmental Waste Associated With Devices and Technology
    Actual Study Start Date :
    Sep 19, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Apr 30, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    AID Group

    We anticipate enrolling between 30 and 50 participants who will be recruited to participate in the Automated Insulin Delivery (AID) system study.

    MDI + CGM Group

    We anticipate that between 10 and 30 participants will be enrolled in the study and will be utilizing Multiple Daily Injections (MDI) therapy in conjunction with Continuous Glucose Monitoring (CGM). MDI therapy will be defined as administering three or more injections per day.

    Outcome Measures

    Primary Outcome Measures

    1. Types and Amount of Diabetes Waste [30 days]

      Types and Amount of Environmental Waste Related to Diabetes Management as Measured Quantitately by Survey and Qualitatively by Photos

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Person with diabetes (self-identified), either type 1 or type 2, who has been diagnosed at least 6 months earlier

    • Age 18 years and above

    • Use of a CGM

    • Use of an insulin pump or on MDI

    • Access to the Internet and e-mail

    • Access to a smartphone with photographic capability

    • Able and willing to provide informed consent

    Exclusion Criteria:
    • Failure to meet any of the inclusion criteria

    • Any condition which, in the opinion of an investigator, would make the subject not qualified to participate in the study.

    • Adults unable to consent

    • Adults unable to speak English

    • Individuals who are not yet adults (infants, children, teenagers)

    • Pregnant women

    • Prisoners

    • Cognitively impaired adults

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Diabetes Technology Society Burlingame California United States 94010
    2 Florida State University Tallahassee Florida United States 32306

    Sponsors and Collaborators

    • Florida State University
    • Diabetes Technology Society

    Investigators

    • Principal Investigator: Jing Wang, PhD, Dean & Prof. of FSU College of Nursing
    • Principal Investigator: David C Klonoff, MD, President of Diabetes Technology Society and Clinical Professor of UCSF Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jing Wang, Principal Investigator, Florida State University
    ClinicalTrials.gov Identifier:
    NCT06071325
    Other Study ID Numbers:
    • STUDY00004453
    First Posted:
    Oct 6, 2023
    Last Update Posted:
    Oct 6, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jing Wang, Principal Investigator, Florida State University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 6, 2023