Diabetes MellitusNCT06071325
Green Digital Diabetes Waste Project
An observational study of Diabetes Mellitus and Diabetes Mellitus, Type 2, run by Florida State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- Type of treatment
- Injection or infusion
- How many people
- 49 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Sep 2023to 18 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Diabetes Technology Society
Burlingame, California, 94010
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: 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.
Read the 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.
- Keywords
- Continuous glucose monitor, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Multiple daily injection, Insulin pump, Diabetes waste
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Types and Amount of Diabetes Waste
Types and Amount of Environmental Waste Related to Diabetes Management as Measured Quantitately by Survey and Qualitatively by Photos
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start19 Sep 2023
- Primary completion18 Apr 2024
- Study completion18 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes Technology Society
- Responsible party
- Principal investigator, Jing Wang, Florida State University
- Investigators
- Jing Wang, PhD, Principal investigator, Dean & Prof. of FSU College of NursingDavid C Klonoff, MD, Principal investigator, President of Diabetes Technology Society and Clinical Professor of UCSF Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071325
- Sponsor's protocol ID
- STUDY00004453
- Status last verified
- Apr 2024
- First submitted
- 3 Oct 2023
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make individual participant data (IPD) available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Green Digital Diabetes Waste Project: Quantifying the Amount of Environmental Waste Associated With Devices and Technology
- ClinicalTrials.gov ID
- NCT06071325
- Acronym / sponsor ID
- STUDY00004453
- Keywords
- Continuous glucose monitor, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Multiple daily injection, Insulin pump, Diabetes waste
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Diabetes Technology Society
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 18 Apr 2024 (actual)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Types and Amount of Diabetes Waste
Time frame: 30 days
Types and Amount of Environmental Waste Related to Diabetes Management as Measured Quantitately by Survey and Qualitatively by Photos
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No. No plan to make individual participant data (IPD) available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Wang, PhD principal investigator
Dean & Prof. of FSU College of Nursing
David C Klonoff, MD principal investigator
President of Diabetes Technology Society and Clinical Professor of UCSF Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Diabetes Mellitus, Type 2, run by Florida State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Types and Amount of Diabetes Waste (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.