NCT06071325

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2024

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

7 months

First QC Date

October 3, 2023

Last Update Submit

April 23, 2024

Conditions

Keywords

Continuous glucose monitorType 1 Diabetes MellitusType 2 Diabetes MellitusMultiple daily injectionInsulin pumpDiabetes waste

Outcome Measures

Primary Outcomes (1)

  • 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

    30 days

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Diabetes Technology Society

Burlingame, California, 94010, United States

Location

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 3, 2023

First Posted

October 6, 2023

Study Start

September 19, 2023

Primary Completion

April 18, 2024

Study Completion

April 18, 2024

Last Updated

April 24, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

No plan to make individual participant data (IPD) available to other researchers

Locations