670G Advanced Closed Loop

Clinical Study Details

Title

Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects

 

Description

The purpose of this study is to evaluate the safety of the Advanced Hybrid Closed Loop system (AHCL) in type 1 diabetes adult and pediatric subjects in a home setting.  The main objective in conducting this research is to collect data from patients who use the AHCL system at home, at work, at school and everywhere else.

This study is a multi-center, single arm study in insulin-requiring adult and pediatric subjects with type 1 diabetes. Ten subjects will be recruited at Stanford and 250 subjects (aged 7-75) will be enrolled at up to 30 investigational centers in the US.

This study involves the use of the Medtronic 670G Version 4.0 (Advance Hybrid Closed Loop), and the Guardian Sensor and Link Transmitter (3).  The study will have both meal and exercise challenges to test the set point of 100mg/dL and 120mg/dL.  

The study period will be approximately 90 days long including a Run-In and then Study period.  The study will include nine office visits and nine phone visits.

Inclusion Criteria

  • Age 7 – 17 (age 7-13 with diagnosis of T1D for 1 year or more; 14-17 with diagnosis of T1D for 2 years or more).
  • Willing to perform ≥ 4 finger stick blood glucose measurements daily; required sensor calibrations; willing to wear the system continuously throughout the study
  • HbA1c less than 10%
  • TSH in the normal range
  • Pump therapy for greater than 6 months (with or without CGM experience)
  • Willing to upload data from the study pump;
  • If subject has celiac disease, it has been adequately treated as determined by the investigator
  • Subject is either taking Humalog or Novolog
  • Subject must have a companion or caregiver available at night for the duration of the study period, including meal and exercise challenges, who in the same home.

Exclusion Criteria

  • Subject has a history of 1 or more episodes of severe hypoglycemia, which required medical assistance, ER visit,  in the following during the 6 months prior to Screening:
  • A primary diagnosis of uncontrolled diabetes
  • Subject has Hypoglycemia Unawareness,
  • Subject is unable to tolerate tape adhesive in the area of sensor placement
  • Pregnancy
  • Subject is being treated for hyperthyroidism at time of Screening
  • Subject has had Diabetic Ketoacidosis (DKA) in the 6 months prior to Screening.
  • Subject has serum creatinine of >2 mg/dL

More Info

If you're interested in learning more about this study, please reach out to the research coordinator listed on the right. You may also download the consent form, assent form, and any other documents linked on the right.


Study Contact

Eliana Frank

(650) 721- 8782

elianaf@stanford.edu

Study Documents