Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1212 participants
OBSERVATIONAL
2019-01-17
2020-04-25
Brief Summary
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Detailed Description
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Online forms will allow participants to report weekly device issues and serious adverse events including severe hypoglycemia, diabetic ketoacidosis, and hospitalizations. General data updates will be obtained after three, six, and 12 months (and every six months thereafter if study participation continues). A fingerstick blood sample will be collected for HbA1c measurement after three months for cohort A and after six and 12 months for both cohorts. Quality-of-life/psychosocial and treatment satisfaction questionnaires will be completed after six and 12 months; new users also will complete questionnaires after 3 months. Virtual focus groups will be completed within the first three months of starting Loop and at 12 months.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort A
Individuals who have not started Loop or who have been on Loop fewer than 7 days at the time of enrollment.
Loop
The Loop System consists of an insulin pump (certain versions of Medtronic insulin pumps) and a Dexcom or Medtronic CGM. The system includes an iPhone with the Loop app and a RileyLink to communicate between the pump and iPhone. An Apple Watch may optionally be used with the system.
Cohort B
Participants who have been using Loop 7 or more days at the time of enrollment.
Loop
The Loop System consists of an insulin pump (certain versions of Medtronic insulin pumps) and a Dexcom or Medtronic CGM. The system includes an iPhone with the Loop app and a RileyLink to communicate between the pump and iPhone. An Apple Watch may optionally be used with the system.
Interventions
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Loop
The Loop System consists of an insulin pump (certain versions of Medtronic insulin pumps) and a Dexcom or Medtronic CGM. The system includes an iPhone with the Loop app and a RileyLink to communicate between the pump and iPhone. An Apple Watch may optionally be used with the system.
Eligibility Criteria
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Inclusion Criteria
* Currently have, or have ordered, the hardware devices necessary to use Loop
* Currently use Loop or have plans to start using Loop for insulin delivery
* Willing and able to provide informed consent (or be a parent or other legally authorized representative) and to provide the data and complete questionnaires that are part of the protocol
* Resident of U.S.
Exclusion Criteria
ALL
No
Sponsors
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Stanford University
OTHER
Tidepool Project
UNKNOWN
RileyLink
UNKNOWN
Jaeb Center for Health Research
OTHER
Responsible Party
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Principal Investigators
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John Lum, MS
Role: PRINCIPAL_INVESTIGATOR
Jaeb Center for Health Research
Locations
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Jaeb Center for Health Research
Tampa, Florida, United States
Countries
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References
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Suttiratana SC, Wong JJ, Lanning MS, Dunlap A, Hanes SJ, Hood KK, Lal RA, Naranjo D. Qualitative Study of User Experiences with Loop, an Open-Source Automated Insulin Delivery System. Diabetes Technol Ther. 2022 Jun;24(6):416-423. doi: 10.1089/dia.2021.0485. Epub 2022 May 12.
Wong JJ, Suttiratana SC, Lal RA, Lum JW, Lanning MS, Dunlap A, Arbiter B, Hanes SJ, Bailey RJ, Hood KK, Naranjo D. Discontinued Use of the Loop Insulin Dosing System: A Mixed-Methods Investigation. Diabetes Technol Ther. 2022 Apr;24(4):241-248. doi: 10.1089/dia.2021.0362.
Other Identifiers
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LOOP
Identifier Type: -
Identifier Source: org_study_id
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