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The Loop Observational Study (LOS)

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ClinicalTrials.gov Identifier: NCT03838900
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Collaborators:
Stanford University
Tidepool Project
RileyLink
Information provided by (Responsible Party):
Jaeb Center for Health Research

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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 1 Device: Loop

Detailed Description:

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.


Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of Individuals With Type 1 Diabetes Using the Loop System for Automated Insulin Delivery
Actual Study Start Date : January 17, 2019
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort Intervention/treatment
Cohort A
Individuals who have not started Loop or who have been on Loop fewer than 7 days at the time of enrollment.
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.

Cohort B
Participants who have been using Loop 7 or more days at the time of enrollment.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals using or planning to use the Loop system
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838900


Contacts
Contact: Victoria R Barnes-Lomen, MS 813-945-8690 vbarneslomen@jaeb.org

Locations
United States, Florida
Jaeb Center for Health Research Recruiting
Tampa, Florida, United States, 33647
Contact: Victoria Barnes-Lomen    813-975-8690    loopstudy@jaeb.org   
Contact: John Lum    813-975-8690    loopstudy@jaeb.org   
Principal Investigator: John W Lum, M.S.         
Sub-Investigator: Roy W Beck, M.D., Ph.D.         
Sponsors and Collaborators
Jaeb Center for Health Research
Stanford University
Tidepool Project
RileyLink
Investigators
Principal Investigator: John Lum, MS Jaeb Center for Health Research

Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT03838900     History of Changes
Other Study ID Numbers: LOOP
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jaeb Center for Health Research:
Loop
RileyLink
Type 1 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases