The Loop Observational Study

Diabetes Mellitus, Type 1 Clinical Trial

— LOS  

Official title:

An Observational Study of Individuals With Type 1 Diabetes Using the Loop System for Automated Insulin Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03838900
• Other study ID #: LOOP
• Status: Completed
• Start date: January 17, 2019
• Est. completion date: April 25, 2020

Study information

• Verified date: August 2020
• Source: Jaeb Center for Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1212
• Est. completion date: April 25, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Jaeb Center for Health Research	Tampa	Florida

Sponsors (4)

Lead Sponsor	Collaborator
Jaeb Center for Health Research	RileyLink, Stanford University, Tidepool Project

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Loop Baseline General Data Collection	Self-report participant's basic information. No scale provided, variable responses.	Enrollment
Other	Summary statistics for CGM metrics	Continuous CGM data from participant's Tidepool account.	6 months and 12 months
Other	Loop Additional Form for Current Loop Users	Self-report of participant's use of Loop and Loop related features. No scale provided, variable responses.	Enrollment (cohort B), 3 Months (cohort A), 6 Months, and 12 Months
Other	LoopHoles Survey	Self-report of participant's patterns of Loop use. No scale provided, variable responses.	Enrollment (cohort B), 3 Months (cohort A), 6 Months, and 12 Months
Other	Pittsburgh Sleep Quality Index	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.	Enrollment, 3 Months (cohort A), 6 Months, and 12 Months
Other	Satisfaction of diabetes technology.	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.	Enrollment, 3 Months (cohort A), 6 Months, and 12 Months
Other	Automated Insulin Delivery Satisfaction	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.	Enrollment (Cohort B), Month 3 (Cohort A), Month 6, Month 12
Other	HbA1c	Blood sample.	Enrollment, Month 3 (Cohort A), Month 6, Month 12
Other	Device issues related to Loop	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.	Weekly from 7 days after enrollment to 12 months
Other	Hypoglycemia Confidence Scale	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.	Enrollment, Month 3 (Cohort A), Month 6, Month 12
Other	Hypoglycemia Fear Survey - Worry Scale	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.	Enrollment, Month 3 (Cohort A), Month 6, Month 12
Other	Risk Taking Questions	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.	Enrollment, Month 3 (Cohort A), Month 6, Month 12
Other	T1-DDS (Management Distress Items)	Standardized questionnaire. Feelings about diabetes management. Overall scores range from 1 to 6, with higher scores indicating higher distress over diabetes management.	Enrollment, Month 3 (Cohort A), Month 6, Month 12
Other	Device Discontinuation or Non-start Reasons	No scale questionnaire allowing varied responses about why participant's stopped using Loop or why they never started.	Up to 12 months, as needed
Other	Loop Follow-Up General Data Collection	Self-report of participant's basic information. No scale provided, variable responses.	Month 3 (Cohort A), Month 6, Month 12
Primary	Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events	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.	6 Months
Primary	Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events	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.	6 Months
Primary	Measure of Loop Safety by Self-Report of Hospitalization Events	Number of hospitalizations and event outcomes on the Adverse Event and Device Issue - Loop survey.	6 Months
Secondary	Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events	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.	12 Months
Secondary	Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events	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.	12 Months
Secondary	Measure of Loop Safety by Self-Report of Hospitalization Events	Number of hospitalizations and event outcomes on the Adverse Event and Device Issue - Loop survey.	12 Months