Hybrid Closed Loop Pivotal Trial in Type 1 Diabetes
|Type 1 Diabetes||Device: Insulin Pump Other: i-STAT blood testing Other: Blood Glucose Meter testing|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Safety Evaluation of the Hybrid Closed Loop (HCL) System in Type 1 Diabetes|
- Change in A1C [ Time Frame: Baseline and 3 months ]There is no statistically powered primary endpoint in this study. However, there will be a descriptive analysis of change in A1C.
- Number of Severe Hypoglycemia Events [ Time Frame: 3 months ]There is no statistically powered secondary endpoint in this study. However, there will be a descriptive analysis of the number of Severe Hypoglycemia events.
- Number of Diabetic Ketoacidosis (DKA) Events [ Time Frame: 3 months ]There is no statistically powered secondary endpoint in this study. However, there will be a descriptive analysis on number of Diabetic Ketoacidosis (DKA) Event.
|Study Start Date:||June 2015|
|Estimated Study Completion Date:||May 2018|
|Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Experimental: Study Arm
All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm
Device: Insulin Pump
Closed Loop Algorithm
Other Name: MMT-670GOther: i-STAT blood testing
Intravenous i-STAT blood testing is used for reference validationOther: Blood Glucose Meter testing
Frequent finger stick blood glucose testing using a Blood Glucose meter is required
The study will proceed as follows:
A total of up to 150 subjects (age 14 - 75) will be enrolled at up to 10 investigational centers (9 in the US, 1 in the Europe, Middle East and Africa (EMEA) region) in order to reach 100 subjects who will complete the HCL study. The 2-week run-in period will be used to allow subjects to become familiar with new study devices. During the two week run-in period subjects will be using the Study Pump (670G) with the Sensor Augmented Pump function only activated (i.e. SmartGuard OFF and HCL OFF).
Study Period - At Home:
Following the two week run-in period using the Study Pump (670G), all subjects will participate in a 3-month study period.
Subjects will be required to have a companion with them during the night for the duration of the study period. Companions will need to be under the same roof, but not necessarily in the same bedroom. During the Hotel stay where subjects are monitored closely, the presence of a companion is not necessary.
Study Period - Hotel Study Subjects will participate in a Hotel study (6 days, 5 nights), with the remainder of the study period to be spent at home.
All subjects will undergo daytime and nighttime Frequent Sample Testing (FST) for approximately 24 hours during the Hotel study with YSI or i-STAT® used as a reference value.
With respect to meals, subjects will be allowed to eat as they normally do.
Continued Access Program Subjects will be given the opportunity to extend use of their study devices for a period of 2 years. If subjects choose to participate in the continuation period, they will retain the study devices at the end of study period visit or receive them back in the event they have been returned to study staff already. During the continuation period, subjects will come in for office visits every 3 months. At each of the quarterly visits, subjects will be asked about the occurrence of adverse events and device complaints.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02463097
|United States, California|
|Escondido, California, United States, 92026|
|Stanford University Medical Center|
|Palo Alto, California, United States, 94035|
|United States, Colorado|
|Barbara Davis Center for Childhood Diabetes (Adult)|
|Aurora, Colorado, United States, 80045|
|Barbara Davis Center for Childhood Diabetes (Pediatric)|
|Aurora, Colorado, United States, 80045|
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06520|
|United States, Georgia|
|Atlanta Diabetes Associates|
|Atlanta, Georgia, United States, 30318|
|United States, Minnesota|
|Park Nicollet Clinic-International Diabetes Center - Adult and Pediatric|
|Minneapolis, Minnesota, United States, 55416|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22903|
|United States, Washington|
|Rainer Clinical Research Center|
|Renton, Washington, United States, 98057|
|Institute of Endocrinology, Sheba Medical Center|
|Tel Aviv, Israel, 52621|