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Completed

NCT Number: NCT03838900

The Loop Observational Study

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Jaeb Center for Health Research

Tampa, Florida, 33647, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Loop

Device

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.

Primary outcomes

  1. Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events

    Time frame: 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.

  2. Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events

    Time frame: 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.

  3. Measure of Loop Safety by Self-Report of Hospitalization Events

    Time frame: 6 Months

    Number of hospitalizations and event outcomes on the Adverse Event and Device Issue - Loop survey.

Secondary outcomes

  1. Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events

    Time frame: 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.

  2. Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events

    Time frame: 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.

  3. Measure of Loop Safety by Self-Report of Hospitalization Events

    Time frame: 12 Months

    Number of hospitalizations and event outcomes on the Adverse Event and Device Issue - Loop survey.

Other outcomes

  1. Loop Baseline General Data Collection

    Time frame: Enrollment

    Self-report participant's basic information. No scale provided, variable responses.

  2. Summary statistics for CGM metrics

    Time frame: 6 months and 12 months

    Continuous CGM data from participant's Tidepool account.

  3. Loop Additional Form for Current Loop Users

    Time frame: 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.

  4. LoopHoles Survey

    Time frame: 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.

  5. Pittsburgh Sleep Quality Index

    Time frame: 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.

  6. Satisfaction of diabetes technology.

    Time frame: 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.

  7. Automated Insulin Delivery Satisfaction

    Time frame: 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.

  8. HbA1c

    Time frame: Enrollment, Month 3 (Cohort A), Month 6, Month 12

    Blood sample.

  9. Device issues related to Loop

    Time frame: 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.

  10. Hypoglycemia Confidence Scale

    Time frame: 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.

  11. Hypoglycemia Fear Survey - Worry Scale

    Time frame: 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.

  12. Risk Taking Questions

    Time frame: 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.

  13. T1-DDS (Management Distress Items)

    Time frame: 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.

  14. Device Discontinuation or Non-start Reasons

    Time frame: Up to 12 months, as needed

    No scale questionnaire allowing varied responses about why participant's stopped using Loop or why they never started.

  15. Loop Follow-Up General Data Collection

    Time frame: Month 3 (Cohort A), Month 6, Month 12

    Self-report of participant's basic information. No scale provided, variable responses.

Sponsors and collaborators

Lead sponsor

Jaeb Center for Health Research

Other

Collaborators

  • RileyLink
  • Stanford University
  • Tidepool Project

Registry information

Official study title

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

Acronym: LOS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 12, 2019
Registry last updated
Aug 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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