Feasibility Studies of Personalized Closed Loop

Feasibility Study With Personalized Closed Loop (PCL)

This is a single arm study comprised of a series of feasibility studies.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Cloud-based Digital Twin and Meal Prediction algorithms

Detailed Description

Feasibility Study Part 2 (i.e. Feasibility 2): Feasibility 2 is the focus of the current version of the study protocol.

This study will include 2 separate Cohorts of individuals, based on the algorithms being studied:

Cohort A: The main purpose of this cohort is to test the Digital Twin insulin delivery algorithm adaptation

Cohort C: The main purpose of this cohort is to test a meal prediction algorithm

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center - Adults
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center / Pediatric
  • Florida
    • Tampa, Florida, United States, 33612
      • University of South Florida Diabetes Center
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes Associates
    • Roswell, Georgia, United States, 30076
      • Endocrine Research Solutions, Inc.
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Diabetes
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
    • Saint Louis Park, Minnesota, United States, 55416
      • Park Nicollet International Diabetes Center
  • Tennessee
    • Bartlett, Tennessee, United States, 38133
      • AM Diabetes And Endocrinology Center
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

General Inclusion Criteria

1. Subject is age 2-80 years at time of Visit 1. Note: See staged enrollment reference for adult and pediatric subjects in the Study Design section

2. Subject has a clinical diagnosis of type 1 diabetes.

   1. Subjects 7 years of age and older: Diagnosed at least 1 year prior to Visit 1
   2. Subjects 2-6 years of age: Diagnosed at least 3 months prior to Visit 1

   Study-specific inclusion criteria

3. Subject must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
4. If subject has a history of hypothyroidism, must have at least 1 documented normal thyroid-stimulating hormone (TSH) on historical labs within 12 months of Visit 1. A subject without a history of hyperthyroidism is not expected to have a TSH test
5. Subjects and their parent(s)/guardian(s) must have Internet access , a computer system that meets the requirements for uploading the study pump and Smartphone that meets study requirements.
6. Subject must have a companion or caregiver available at night for the duration of the study period who resides (or will live) in in the same building (or home). This requirement may be verified by subject report at screening visit.
7. If subject has celiac disease, it has been adequately treated as determined by the investigator.

8. Subjects and their parent(s)/guardian(s) are willing to take one of the following insulins and can financially support the use of either of the 2 insulin preparations throughout the course of the study (i.e. co-payments for insulin with insurance or able to pay full amount)

   • Humalog™* (insulin lispro injection)
   • NovoLog™* (insulin aspart)

Exclusion Criteria:

1. Subject has a history of 1 or more episodes of severe hypoglycemia, which resulted in any the following during the last 1 year prior to Visit 1

   1. Medical assistance (i.e. Paramedics, Emergency Room (ER) or Hospitalization)
   2. Coma
   3. Seizures
2. Subject is unable to tolerate tape adhesive in the area of sensor placement.
3. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
4. Women of child-bearing potential who have a positive pregnancy test at Visit 1 or plan to become pregnant during the course of the study
5. Females who are sexually active and able to conceive will be excluded if they are not using an effective method of contraception and do not agree to continue using an effective method of contraception for the duration of the study as determined by investigator.
6. Subject has a cardiovascular condition which the Study Investigator determines should exclude the subject, e.g. ventricular rhythm disturbance, hypertrophic cardiomyopathy, recent myocardial infarction in the last year prior to Visit 1.
7. Subject is being treated for hyperthyroidism at time of Visit 1.
8. Subject has a diagnosis of adrenal insufficiency.
9. Subject has had Diabetic Ketoacidosis (DKA) within 1 year prior to Visit 1.
10. Subject has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of visit 1, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study.
11. Subject is actively participating in an investigational study (e.g., drug or device) wherein he/she has received treatment from an investigational study (drug or device) in the last 2 weeks prior to Visit 1. Please note participation in observational study is acceptable.
12. Subject has been hospitalized or has visited the ER in the 6 months prior to Visit 1 resulting in a primary diagnosis of uncontrolled diabetes.
13. Subject is currently abusing illicit drugs.
14. Subject is currently abusing alcohol.
15. Subject is using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of Visit 1.
16. Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator.
17. Subject has elective surgery planned that requires general anesthesia during the course of the study.
18. Subject diagnosed with current eating disorder such as anorexia or bulimia.
19. Subject has been diagnosed with chronic kidney disease that results in chronic anemia.
20. Subject is on dialysis.
21. Subject has serum creatinine of >2 mg/dL, as confirmed through historical labs within 1 year prior to Visit 1.
22. Subject is a member the research staff involved with the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Algorithm Testing; The main purpose of this cohort is to test the Digital Twin insulin delivery algorithm and the Meal Prediction algorithm The study population will be enrolled as 2 separate cohorts to test each algorithms individually	Device: Cloud-based Digital Twin and Meal Prediction algorithms; Test safety and effectiveness of the Digital Twin and Meal Prediction algorithms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Severe Hypoglycemic Event - Cohort A	Number of severe hypoglycemic events occurred in the study in Cohort A	approximately 3.5 months
Number of Diabetic Ketoacidosis (DKA) Event - Cohort A	Number of Diabetic Ketoacidosis (DKA) event occurred in the study in Cohort A	approximately 3.5 months
Number of Severe Hypoglycemic Event - Cohort C	Number of severe hypoglycemic events occurred in the study in Cohort C	approximately 3.5 months
Number of Diabetic Ketoacidosis (DKA) Event - Cohort C	Number of Diabetic Ketoacidosis (DKA) event occurred in the study in Cohort C	approximately 3.5 months
Percentage of Time in Euglycemia - Cohort A	The overall mean percentage of time in Euglycemia (70-180 mg/dL) in Cohort A	approximately 3.5 months
Percentage of Time in Euglycemia - Cohort C	The overall mean percentage of time in Euglycemia (70-180 mg/dL) in Cohort C	approximately 3.5 months

Collaborators and Investigators

• Sponsor: Medtronic Diabetes

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Actual): January 27, 2022
• Study Completion (Actual): January 27, 2022

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CIP326

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No