Clinical Trial Details

NCT ID: NCT02660827
Date Last Changed: July 12, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating Insulin Pump, i-STAT blood testing, Blood Glucose Meter Testing and YSI Blood Testing for the treatment of Type 1 Diabetes

Research Study Title

Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects With Type 1 Diabetes

Purpose

This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in pediatric subjects with type 1 diabetes on insulin pump therapy. The purpose of this study is to demonstrate that the closed loop algorithm that is built into the 670G insulin pump is safe as part of the overall system.

To Learn more

Recruitment Details

Gender
All
Age
2 to 13 Years
Overall Status
Recruiting
Lead Sponsor
Medtronic Diabetes
Duration
24 Months
Facility Type
N/A
Compensation

Eligibility

All ages 2 Years to 13 Years

Inclusion Criteria:

General Inclusion Criteria

  1. Subject is age 2-13 years at time of screening

  2. Subject has a clinical diagnosis of type 1 diabetes for 1 year or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis

Study-specific inclusion criteria

  1. Subject must have a minimum daily insulin requirement (Total Daily Dose) of > 8 units

  2. Subject and their parent(s)/guardian(s) are willing to participate in an overnight visit at the end of the run-in period.

  3. Subject 7-13 years of age and their parent(s)/guardian(s) are willing to participate in a hotel study for the specified duration of hotel stay.

  4. Subject 2-6 years of age and their parent(s)/guardian(s) are willing to participate in an extended visit during the study period to perform Frequent Sample Testing.

  5. Subject 2-6 years of age are willing and able to have sensor inserted in the abdomen as per investigator discretion.

  6. Subject must have companion 18 years or older who will sleep in the same dwelling place every night during the study period. This requirement may be verified by subject report at screening visit.

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

  8. Subject is willing to perform required sensor calibrations

  9. Subject is willing to wear the system continuously throughout the study

  10. Subject has a Glycosylated hemoglobin (A1C) value less than 10.0% (as processed by Central Lab) at time of screening visit Note: All HbA1C blood specimens will be sent to and tested by a NGSP certified Central Laboratory. A1C testing must follow National Glycohemoglobin Standardization Program (NGSP) standards.

  11. Subject has TSH in the normal range OR if the TSH is out of normal reference range the Free T3 is below or within the lab's reference range and Free T4 is within the normal reference range.

  12. Pump therapy for greater than 6 months prior to screening (with or without CGM experience)

  13. Subjects and their parent(s)/guardian(s) are willing to upload data from the study pump; must have Internet access and a computer system that meets the requirements for uploading the study pump

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

  15. 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)

  16. Humalog® (insulin lispro injection)

  17. NovoLog® (insulin aspart)

  18. Subjects and their parent(s)/guardian(s)/companions must be able to speak and be literate in English as verified by the investigator

Exclusion Criteria:

  1. Subject has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:

  2. Medical assistance (i.e. Paramedics, Emergency Room ( ER) or Hospitalization)

  3. Coma

  4. Seizures

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

  6. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)

  7. 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.

  8. Subject has a cardiovascular condition which the investigator determines should exclude the subject, i.e. ventricular rhythm disturbance, hypertrophic cardiomyopathy

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

  10. Subject has diagnosis of adrenal insufficiency

  11. Subject has had DKA in the 6 months prior to screening visit.

  12. Subject has taken any oral, injectable, or intravenous (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

  13. 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

  14. Subject has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes

  15. Subject is currently abusing illicit drugs

  16. Subject is currently abusing marijuana.

  17. Subject is currently abusing prescription drugs

  18. Subject is currently abusing alcohol

  19. 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 screening

  20. 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

  21. Subject has elective surgery planned that requires general anesthesia during the course of the study

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

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

  24. Subject diagnosed with current eating disorder such as anorexia or bulimia

  25. Subject has been diagnosed with chronic kidney disease that results in chronic anemia

  26. Subject has a hematocrit that is below the normal reference range of lab used.

  27. Subject is on dialysis

  28. Subject has serum creatinine of > 2 mg/dL.

Site Locations (5)

Country State City Zip Facility and Contact
United States California Torrance 90505 SoCal Diabetes
Mary Halvorson
310-560-8376
halvorson@socaldiabetes.com

Kevin Kaiserman, MD
Principal Investigator
United States Colorado Aurora 80045 Barbara Davis Center
Maninderpal Sethi
303-724-6773
maninderpal.sethi@ucdenver.edu

Greg Forlenza, MD
Principal Investigator
United States Florida Tampa 33620 University of South Florida - USF Health
Emily Eyth
813-974-2793
emilyeyth@health.usf.edu

Dorothy Shulman, MD
Principal Investigator
United States Idaho Idaho Falls 83404 Rocky Mountain Diabetes and Osteoporosis Center
Mark Sulik
208-522-6005
mark@idahomed.com

David Liljenquist, MD
Principal Investigator
United States Michigan Ann Arbor 48109 University of Michigan
Janet Dominowski
734-764-5175
jandomin@med.umich.edu

Michael Wood, MD
Principal Investigator

Contact

Thomas Troub
818.576.3142
E-mail:

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