Clinical Trial Details

NCT ID: NCT02748018
Date Last Changed: June 19, 2017

Overview

Research Study Summary

A clinical research study of 670G Insulin Pump and Fourth Generation Glucose Sensor system for the treatment of Type 1 Diabetes

Research Study Title

Multi-center, Randomized, Adaptive, Controlled Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System at Home

Purpose

The purpose of this study is to demonstrate the safety and effectiveness of the Hybrid Closed Loop system (HCL) in adult and pediatric patients with type 1 diabetes in the home setting. A diverse population of patients with type 1 diabetes will be studied. The study population will have a large range for duration of diabetes and glycemic control, as measured by glycosylated hemoglobin (A1C). They will be enrolled in the study regardless of their prior diabetes regimen, including using Multiple Daily Injections (MDI), Continuous Subcutaneous Insulin Infusion (CSII) or Sensor-Augmented Pump therapy (SAP)

To Learn more

Recruitment Details

Gender
All
Age
7 to 75 Years
Overall Status
Recruiting
Lead Sponsor
Medtronic Diabetes
Duration
51 Months
Facility Type
N/A
Compensation

Eligibility

All ages 7 Years to 75 Years

Inclusion Criteria:

  1. Subject is age 2-80 years at time of screening

a. Subjects 2-6 years of age will be allowed to enroll in the post approval study, once DMC has reviewed data from 10 subjects age 2-4 years who have completed participation in the study period of the CEP302 study and has given approval to enroll

  1. Subjects who are 2-21 years are determined by the investigator to have the appropriate, requisite support (family, caregiver or social network) to successfully participate in this study

  2. Subject must have a minimum daily insulin requirement (Total Daily Dose) of equal to or greater than 8 units/day

  3. Subjects who are determined by the investigator to be psychologically sound in order to successfully participate in this study

  4. Subject has been diagnosed with type 1 diabetes for at least three months Note: Determination of classification for diabetes will be based on American Diabetes Association Clinical Practice Guidelines accounting for several patient characteristics such as: age of onset, patient's weight or BMI, history of diabetic ketoacidosis, history of therapy management, and medical records if available.

  5. Subject must be on one of the following management therapies:

  6. Multiple daily injections defined by use of rapid analogue with meals and long acting analogue (i.e. detemir or glargine), without CGM

  7. Insulin pump therapy with or without CGM

  8. Subject is willing to perform ≥ 4 finger stick blood glucose measurements daily

  9. Subject is willing to perform required study procedure

  10. Subject is willing to wear the system continuously throughout the study for at least 80% of the time.

  11. Subject is willing to upload data at least weekly from the study pump/meter, must have Internet access and a computer system that meets the requirements for uploading the study pump/meter for data collection

  12. Subject must be willing to use the study glucose meter system (i.e. along with study meter strips). This includes stopping alternative glucose meter systems (such as Freestyle Libre)

  13. If subject has celiac disease, it has been adequately treated as determined by the investigator

  14. Subject with the diagnosis of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease, within 1 year of screening, will be included in the study with the consent of the subject's cardiologist

  15. Subject is willing to take one of the following insulins and can financially afford to use 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) b. Humalog® (insulin lispro injection) c. NovoLog® (insulin aspart)

Exclusion Criteria:

  1. Subject is on MDI with concurrent CGM therapy for at least 3 months prior to Screening

  2. Subject participated in any Closed Loop study in the past.

  3. Subject is unable to tolerate tape adhesive in the area of sensor placement

  4. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection) or area of infusion set placement

  5. Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study

  6. Subject is being treated for hyperthyroidism at time of screening

  7. Subject has an abnormality (out of reference range) in thyroid-stimulating hormone (TSH) at time of screening visit

  8. Subject has taken any oral, injectable, or IV glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study. (Subjects may be rescreened after 1 month if they fail this exclusion criteria)

  9. Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks

  10. Subject is currently abusing illicit drugs or marijuana

  11. Subject is currently abusing prescription drugs

  12. Subject is currently abusing alcohol

  13. Subject is using pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides, DPP-4 inhibitors or sulfonylureas at time of screening

  14. 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

  15. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening

  16. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation

  17. Subject diagnosed with current moderate to severe eating disorder such as anorexia or bulimia

  18. Subject has been diagnosed with chronic kidney disease requiring dialysis or resulting in chronic anemia

  19. Subjects who are currently being actively treated for cancer.

  20. Subject who is designated as a research staff member for this study

Site Locations (5)

Country State City Zip Facility and Contact
United States California Walnut Creek 94598 Diablo Clinical Research
Ava Paulazzo
925-930-7267
apaulazzo@diabloclinical.com

Mark Christiansen, MD
Principal Investigator
United States Georgia Atlanta 30318 Atlanta Diabetes Associates
404-355-4393

Bruce Bode, MD
Principal Investigator
United States Georgia Roswell 30076 Endocrine Research Solutions
Jessica Tapia
678-878-4750
jessiet62@gmail.com

John Reed, MD
Principal Investigator
United States Michigan Bloomfield Hills 48302 Grunberger Diabetes Institute
Linda Aman
248-335-7740
laman@gdi-pc.com

George Grunberger, MD
Principal Investigator
United States Washington Renton 98057 Rainier Clinical Research
Kristen Hughes
425-251-1720
khughes@rainier-research.com

Ronald Brazg, MD
Principal Investigator

Contact

Thomas Troub
(818) 576-3142
E-mail:

DISCLAIMER: CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties. This information is designed to help patients find clinical trials of interest and contact the research centers conducting the trials.