Hybrid Closed Loop Pivotal Trial in Type 1 Diabetes
Safety Evaluation of the Hybrid Closed Loop (HCL) System in Type 1 Diabetes
1 other identifier
interventional
124
2 countries
10
Brief Summary
This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedResults Posted
Study results publicly available
April 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedApril 16, 2019
April 1, 2019
9 months
May 28, 2015
March 7, 2017
April 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in A1C
There is no statistically powered primary endpoint in this study. However, there will be a descriptive analysis of change in A1C.
Baseline and 3 months
Secondary Outcomes (2)
Number of Severe Hypoglycemia Events
3 months
Number of Diabetic Ketoacidosis (DKA) Events
3 months
Study Arms (1)
Study Arm
EXPERIMENTALAll subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm
Interventions
Eligibility Criteria
You may qualify if:
- Is age 14 - 75 years at time of screening
- Has a clinical diagnosis of type 1 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
- Is willing to participate in a hotel study for the specified duration of hotel stay.
- Must have companion who will sleep in the same dwelling place every night during the study period and should also be able to call the subject daily in the event the subject is traveling.
- Is willing to perform ≥ 4 finger stick blood glucose measurements daily
- Is willing to perform required sensor calibrations
- Is willing to wear the system continuously throughout the study
- Has a Glycosylated hemoglobin (A1C) value less than 10.0% (as processed by Central Lab) at time of screening visit
- 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.
- Pump therapy for greater than 6 months prior to screening (with or without CGM experience)
- Is 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
- If subject has celiac disease, it has been adequately treated as determined by the investigator
- Is 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)
- +11 more criteria
You may not qualify if:
- Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:
- Medical assistance (i.e. Paramedics, Emergency Room ( ER) or Hospitalization)
- Coma
- Seizures
- Is unable to tolerate tape adhesive in the area of sensor placement
- Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
- 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.
- Has had any of the following cardiovascular events within 1 year of screening: 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
- Is being treated for hyperthyroidism at time of screening
- Has diagnosis of adrenal insufficiency
- Has had DKA in the 6 months prior to screening visit.
- Has taken any oral, injectable, or intravenous (IV) steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study
- 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
- Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes
- Currently abusing illicit drugs
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
AMCR Institute
Escondido, California, 92026, United States
Stanford University Medical Center
Palo Alto, California, 94035, United States
Barbara Davis Center for Childhood Diabetes (Adult)
Aurora, Colorado, 80045, United States
Barbara Davis Center for Childhood Diabetes (Pediatric)
Aurora, Colorado, 80045, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
Park Nicollet Clinic-International Diabetes Center - Adult and Pediatric
Minneapolis, Minnesota, 55416, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Rainer Clinical Research Center
Renton, Washington, 98057, United States
Institute of Endocrinology, Sheba Medical Center
Tel Aviv, 52621, Israel
Related Publications (2)
Cordero TL, Garg SK, Brazg R, Bailey TS, Shin J, Lee SW, Kaufman FR. The Effect of Prior Continuous Glucose Monitoring Use on Glycemic Outcomes in the Pivotal Trial of the MiniMed 670G Hybrid Closed-Loop System. Diabetes Technol Ther. 2017 Dec;19(12):749-752. doi: 10.1089/dia.2017.0208. Epub 2017 Nov 17.
PMID: 29148821DERIVEDGarg SK, Weinzimer SA, Tamborlane WV, Buckingham BA, Bode BW, Bailey TS, Brazg RL, Ilany J, Slover RH, Anderson SM, Bergenstal RM, Grosman B, Roy A, Cordero TL, Shin J, Lee SW, Kaufman FR. Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in Adolescents and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2017 Mar;19(3):155-163. doi: 10.1089/dia.2016.0421. Epub 2017 Jan 30.
PMID: 28134564DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Thomas Thoub
- Organization
- Medtronic Minimed
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- 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
Study Record Dates
First Submitted
May 28, 2015
First Posted
June 4, 2015
Study Start
June 1, 2015
Primary Completion
March 1, 2016
Study Completion
October 1, 2018
Last Updated
April 16, 2019
Results First Posted
April 18, 2017
Record last verified: 2019-04