The Loop Observational Study
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/14/2019 |
| Start Date: | January 17, 2019 |
| End Date: | July 15, 2020 |
| Contact: | Victoria R Barnes-Lomen, MS |
| Email: | vbarneslomen@jaeb.org |
| Phone: | 813-945-8690 |
An Observational Study of Individuals With Type 1 Diabetes Using the Loop System for Automated Insulin Delivery
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.
life/psychosocial effects of the Loop DIY automated insulin delivery system.
The study will include both adults and youth in the United States, with a recruitment goal of
up to 1000 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.
up to 1000 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.
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:
We found this trial at
1
site
Tampa, Florida 33647
Principal Investigator: John W Lum, M.S.
Phone: 813-975-8690
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