Feasibility Studies of Personalized Closed Loop

NCT04203823 | Completed Results FDA Device

• 1 other identifier: CIP326
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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 C

  The overall mean percentage of time in Euglycemia (70-180 mg/dL) in Cohort C

  approximately 3.5 months

Study Arms (1)

Algorithm Testing

EXPERIMENTAL

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

Interventions

Cloud-based Digital Twin and Meal Prediction algorithms DEVICE

Test safety and effectiveness of the Digital Twin and Meal Prediction algorithms

Algorithm Testing

Eligibility Criteria

• Age: 2 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Subject has a clinical diagnosis of type 1 diabetes.
• Subjects 7 years of age and older: Diagnosed at least 1 year prior to Visit 1
• Subjects 2-6 years of age: Diagnosed at least 3 months prior to Visit 1
• Subject must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
• 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
• 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.
• 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.
• If subject has celiac disease, it has been adequately treated as determined by the investigator.
• 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)

You may not qualify if:

• 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
• Medical assistance (i.e. Paramedics, Emergency Room (ER) or Hospitalization)
• Coma
• Seizures
• Subject is unable to tolerate tape adhesive in the area of sensor placement.
• Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
• 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
• 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.
• 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.
• Subject is being treated for hyperthyroidism at time of Visit 1.
• Subject has a diagnosis of adrenal insufficiency.
• Subject has had Diabetic Ketoacidosis (DKA) within 1 year prior to Visit 1.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (12)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Barbara Davis Center - Adults

Aurora, Colorado, 80045, United States

Location

Barbara Davis Center / Pediatric

Aurora, Colorado, 80045, United States

Location

University of South Florida Diabetes Center

Tampa, Florida, 33612, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

Endocrine Research Solutions, Inc.

Roswell, Georgia, 30076, United States

Location

Rocky Mountain Diabetes

Idaho Falls, Idaho, 83404, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Park Nicollet International Diabetes Center

Saint Louis Park, Minnesota, 55416, United States

Location

AM Diabetes and Endocrinology Center

Bartlett, Tennessee, 38133, United States

Location

Rainier Clinical Research

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Clinical Study Manager
• Organization: Medtronic

carrie.corrigan@medtronic.com

8185765849

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Arm (Cohort) assignment

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 18, 2019
• Study Start: July 20, 2020
• Primary Completion: January 27, 2022
• Study Completion: January 27, 2022
• Last Updated: May 9, 2023
• Results First Posted: February 15, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)