Diabetes Mellitus, Type 1
Conditions
Keywords
Loop, RileyLink, Type 1 Diabetes
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.
Interventions
DEVICELoop
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.
Sponsors
Stanford University
Tidepool Project
RileyLink
Jaeb Center for Health Research
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events | 6 Months | Number of DKA events and event outcomes on the Adverse Event and Device Issue - Loop survey. DKA events are defined as the development of ketones with a diagnosis of DKA by a medical provider. |
| Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events | 6 Months | Number of severe hypoglycemic events and event outcomes on the Adverse Event and Device Issue - Loop survey. Severe hypoglycemia is defined as low blood sugar that affected the individual's ability to think such that they were unable to treat themselves and needed assistance from someone else. The individual may or may not have lost consciousness. |
| Measure of Loop Safety by Self-Report of Hospitalization Events | 6 Months | Number of hospitalizations and event outcomes on the Adverse Event and Device Issue - Loop survey. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events | 12 Months | Number of DKA events and event outcomes on the Adverse Event and Device Issue - Loop survey. DKA events are defined as the development of ketones with a diagnosis of DKA by a medical provider. |
| Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events | 12 Months | Number of severe hypoglycemic events and event outcomes on the Adverse Event and Device Issue - Loop survey. Severe hypoglycemia is defined as low blood sugar that affected the individual's ability to think such that they were unable to treat themselves and needed assistance from someone else. The individual may or may not have lost consciousness. |
| Measure of Loop Safety by Self-Report of Hospitalization Events | 12 Months | Number of hospitalizations and event outcomes on the Adverse Event and Device Issue - Loop survey. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Automated Insulin Delivery Satisfaction | Enrollment (Cohort B), Month 3 (Cohort A), Month 6, Month 12 | Change in satisfaction of using Loop. Measured using the standardized INSPIRE (Adult, Parent, and Child) questionnaires. The higher the score the more positive the opinion that automated insulin delivery has had a positive impact on the participant's life. |
| HbA1c | Enrollment, Month 3 (Cohort A), Month 6, Month 12 | Blood sample. |
| Device issues related to Loop | Weekly from 7 days after enrollment to 12 months | Weekly self-report of any device issues that interfered with their ability to use Loop on the Adverse Event and Device Issue - Loop survey. No scale provided. |
| Hypoglycemia Confidence Scale | Enrollment, Month 3 (Cohort A), Month 6, Month 12 | Standardized questionnaire. Confidence of managing hypoglycemia during daily tasks. Overall scores range from 1 to 4, with higher scores indicating greater confidence in managing hypoglycemia. |
| Loop Baseline General Data Collection | Enrollment | Self-report participant's basic information. No scale provided, variable responses. |
| Risk Taking Questions | Enrollment, Month 3 (Cohort A), Month 6, Month 12 | Standardized questionnaire about risk taking behavior. Items are scored on a scale of 1 to 10, with a higher score indicating a greater disposition to take risks. |
| T1-DDS (Management Distress Items) | Enrollment, Month 3 (Cohort A), Month 6, Month 12 | Standardized questionnaire. Feelings about diabetes management. Overall scores range from 1 to 6, with higher scores indicating higher distress over diabetes management. |
| Device Discontinuation or Non-start Reasons | Up to 12 months, as needed | No scale questionnaire allowing varied responses about why participant's stopped using Loop or why they never started. |
| Loop Follow-Up General Data Collection | Month 3 (Cohort A), Month 6, Month 12 | Self-report of participant's basic information. No scale provided, variable responses. |
| Hypoglycemia Fear Survey - Worry Scale | Enrollment, Month 3 (Cohort A), Month 6, Month 12 | Standardized survey. Measures level of worry of low blood sugar, for Adult, Parent, and Child. Items are rated on a 5 point Likert scale from 0 to 4. Total scores and sub-scale scores are sum scores of all relative items. For the adult survey, the score ranges from 0-52. For the children's survey, the score ranges from 0-60. For the parent survey, the score ranges from 0-60. A higher score indicates greater fear of hypoglycemia. |
| Summary statistics for CGM metrics | 6 months and 12 months | Continuous CGM data from participant's Tidepool account. |
| Loop Additional Form for Current Loop Users | Enrollment (cohort B), 3 Months (cohort A), 6 Months, and 12 Months | Self-report of participant's use of Loop and Loop related features. No scale provided, variable responses. |
| LoopHoles Survey | Enrollment (cohort B), 3 Months (cohort A), 6 Months, and 12 Months | Self-report of participant's patterns of Loop use. No scale provided, variable responses. |
| Pittsburgh Sleep Quality Index | Enrollment, 3 Months (cohort A), 6 Months, and 12 Months | Standardized questionnaire and scoring. Usual sleeping habits for past month. Questions 1 - 9. Overall scores range from 0 to 21, with lower values representing better sleep quality. |
| Satisfaction of diabetes technology. | Enrollment, 3 Months (cohort A), 6 Months, and 12 Months | Standardized Diabetes Technology Attitudes - 5 with likert scale questions. Each question is scored on a scale of 1 to 5, with a higher score indicating greater satisfaction with diabetes technology. |
Countries
United States
Outcome results
None listed