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Feasibility Studies of Personalized Closed Loop

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ClinicalTrials.gov Identifier: NCT04203823
Recruitment Status : Recruiting
First Posted : December 18, 2019
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

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

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: Cloud-based Digital Twin and Meal Prediction algorithms Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Arm (Cohort) assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study With Personalized Closed Loop (PCL)
Actual Study Start Date : July 20, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of Severe Hypoglycemic Event - Cohort A [ Time Frame: approximately 3.5 months ]
    Number of severe hypoglycemic events occurred in the study in Cohort A

  2. Number of Diabetic Ketoacidosis (DKA) Event - Cohort A [ Time Frame: approximately 3.5 months ]
    Number of Diabetic Ketoacidosis (DKA) event occurred in the study in Cohort A

  3. Percentage of time in Euglycemia - Cohort A [ Time Frame: approximately 3.5 months ]
    The overall mean percentage of time in Euglycemia (70-180 mg/dL) in Cohort A

  4. Number of Severe Hypoglycemic Event - Cohort C [ Time Frame: approximately 3.5 months ]
    Number of severe hypoglycemic events occurred in the study in Cohort C

  5. Number of Diabetic Ketoacidosis (DKA) Event - Cohort C [ Time Frame: approximately 3.5 months ]
    Number of Diabetic Ketoacidosis (DKA) event occurred in the study in Cohort C

  6. Percentage of time in Euglycemia - Cohort C [ Time Frame: approximately 3.5 months ]
    The overall mean percentage of time in Euglycemia (70-180 mg/dL) in Cohort C



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT04203823


Contacts
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Contact: Thomas P Troub 8185763142 thomas.troub@medtronic.com
Contact: Kayce Valerius 763.526.7798 Kayce.j.valerius@medtronic.com

Locations
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United States, California
Loma Linda University Medical Center Active, not recruiting
Loma Linda, California, United States, 92354
Socal Diabetes Withdrawn
Torrance, California, United States, 90505
Diablo Clinical Research Active, not recruiting
Walnut Creek, California, United States, 94598
United States, Colorado
Barbara Davis Center - Adults Active, not recruiting
Aurora, Colorado, United States, 80045
Barbara Davis Center / Pediatric Recruiting
Aurora, Colorado, United States, 80045
Contact: Samantha Lange    303-724-7514    samantha.lange@cuanschutz.edu   
Principal Investigator: Robert Slover, MD         
United States, Florida
University of South Florida Diabetes Center Recruiting
Tampa, Florida, United States, 33612
Contact: Janet Rodriguez    813-974-5499    janetrodriguez@usf.edu   
Principal Investigator: Dorothy Shulman, MD         
United States, Georgia
Atlanta Diabetes Associates Recruiting
Atlanta, Georgia, United States, 30318
Contact: Anna Busby         
Contact: Betsy Childs         
Principal Investigator: Bruce Bode         
Endocrine Research Solutions, Inc. Active, not recruiting
Roswell, Georgia, United States, 30076
United States, Idaho
Rocky Mountain Diabetes Recruiting
Idaho Falls, Idaho, United States, 83404
Contact: Joann Malone    208-528-9650    joann@idahomed.com   
Principal Investigator: David Liljenquist, MD         
United States, Minnesota
Mayo Clinic Active, not recruiting
Rochester, Minnesota, United States, 55905
Park Nicollet International Diabetes Center Active, not recruiting
Saint Louis Park, Minnesota, United States, 55416
United States, Tennessee
AM Diabetes and Endocrinology Center Not yet recruiting
Bartlett, Tennessee, United States, 38133
Contact: Lesley Draffin         
Contact: Kristen Clark         
Principal Investigator: Kashif Latif         
United States, Washington
Rainier Clinical Research Active, not recruiting
Renton, Washington, United States, 98057
Sponsors and Collaborators
Medtronic Diabetes
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Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT04203823    
Other Study ID Numbers: CIP326
First Posted: December 18, 2019    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases