- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06071325
Green Digital Diabetes Waste Project
April 23, 2024 updated by: Jing Wang, Florida State University
Green Digital Diabetes Waste Project: Quantifying the Amount of Environmental Waste Associated With Devices and Technology
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.
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
49
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Burlingame, California, United States, 94010
- Diabetes Technology Society
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Florida
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Tallahassee, Florida, United States, 32306
- Florida State University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adults with diagnosed diabetes mellitus (either Type 1 or Type 2) at least 6 months earlier, and treated with insulin and a continuous glucose monitor (CGM).
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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AID Group
We anticipate enrolling between 30 and 50 participants who will be recruited to participate in the Automated Insulin Delivery (AID) system study.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Types and Amount of Diabetes Waste
Time Frame: 30 days
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Types and Amount of Environmental Waste Related to Diabetes Management as Measured Quantitately by Survey and Qualitatively by Photos
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30 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 19, 2023
Primary Completion (Actual)
April 18, 2024
Study Completion (Actual)
April 18, 2024
Study Registration Dates
First Submitted
October 3, 2023
First Submitted That Met QC Criteria
October 3, 2023
First Posted (Actual)
October 6, 2023
Study Record Updates
Last Update Posted (Actual)
April 24, 2024
Last Update Submitted That Met QC Criteria
April 23, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00004453
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No plan to make individual participant data (IPD) available to other researchers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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