Clinical trial NCT03838900: The Loop Observational Study
Official title: An Observational Study of Individuals With Type 1 Diabetes Using the Loop System for Automated Insulin Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Keywords: Loop
RileyLink
Type 1 Diabetes
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Tidepool Project
name: RileyLink
First posted: 2019-02-12
Enrollment: 1212
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals using or planning to use the Loop system

Brief summary: An observational study to collect data on the efficacy, safety, usability, and quality of life/psychosocial effects of the Loop DIY automated insulin delivery system.

Detailed description: The study will include both adults and youth in the United States, with a recruitment goal of at least 300-1,250 participants. Data to be collected to address the study objective will include CGM metrics; HbA1c; insulin delivery data; carbohydrate data; activity data from HealthKit; self-reported adverse events (e.g., severe hypoglycemia, diabetic ketoacidosis, hospitalizations); self-reported device issues; and psychosocial and user experience/treatment satisfaction surveys.

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.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* 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:

* None

Primary outcomes:
measure: Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events
timeFrame: 6 Months
measure: Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events
timeFrame: 6 Months
measure: Measure of Loop Safety by Self-Report of Hospitalization Events
timeFrame: 6 Months
Secondary outcomes:
measure: Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events
timeFrame: 12 Months
measure: Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events
timeFrame: 12 Months
measure: Measure of Loop Safety by Self-Report of Hospitalization Events
timeFrame: 12 Months
Other outcomes:
measure: Loop Baseline General Data Collection
timeFrame: Enrollment
measure: Summary statistics for CGM metrics
timeFrame: 6 months and 12 months
measure: Loop Additional Form for Current Loop Users
timeFrame: Enrollment (cohort B), 3 Months (cohort A), 6 Months, and 12 Months
measure: LoopHoles Survey
timeFrame: Enrollment (cohort B), 3 Months (cohort A), 6 Months, and 12 Months
measure: Pittsburgh Sleep Quality Index
timeFrame: Enrollment, 3 Months (cohort A), 6 Months, and 12 Months
measure: Satisfaction of diabetes technology.
timeFrame: Enrollment, 3 Months (cohort A), 6 Months, and 12 Months
measure: Automated Insulin Delivery Satisfaction
timeFrame: Enrollment (Cohort B), Month 3 (Cohort A), Month 6, Month 12
measure: HbA1c
timeFrame: Enrollment, Month 3 (Cohort A), Month 6, Month 12
measure: Device issues related to Loop
timeFrame: Weekly from 7 days after enrollment to 12 months
measure: Hypoglycemia Confidence Scale
timeFrame: Enrollment, Month 3 (Cohort A), Month 6, Month 12
measure: Hypoglycemia Fear Survey - Worry Scale
timeFrame: Enrollment, Month 3 (Cohort A), Month 6, Month 12
measure: Risk Taking Questions
timeFrame: Enrollment, Month 3 (Cohort A), Month 6, Month 12
measure: T1-DDS (Management Distress Items)
timeFrame: Enrollment, Month 3 (Cohort A), Month 6, Month 12
measure: Device Discontinuation or Non-start Reasons
timeFrame: Up to 12 months, as needed
measure: Loop Follow-Up General Data Collection
timeFrame: Month 3 (Cohort A), Month 6, Month 12
Locations:
city: Tampa
country: United States
facility: Jaeb Center for Health Research
state: Florida
Study officials:
affiliation: Jaeb Center for Health Research
name: John Lum, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.