Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects With Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT02660827|
Recruitment Status : Completed
First Posted : January 21, 2016
Results First Posted : January 11, 2019
Last Update Posted : January 26, 2022
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Device: Insulin Pump||Not Applicable|
The study will proceed as follows:
Run-in Period - General:
A total of up to 200 subjects (age 2-13) will be enrolled at up to 15 investigational centers (14 in the US, 1 EMEA) in order to reach 120 subjects who will complete the HCL study.
Study Period - At Home:
Following the two week run-in period using the Study Pump (670G), all subjects (age 2-13) will participate in a 3-month study period.
Study Period - Hotel Study Subjects (age 7-13) will participate in a Hotel study (6 days, 5 nights), with the remainder of the study period to be spent at home. Subjects 2-6 years of age are not required to participate in a hotel study. Instead, they will participate in an out-of-home study for 5 consecutive days, 4-6 hours per day.
Continued Access Program Subjects will be given the opportunity to extend use of their study devices for a period of up to 3 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||151 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects With Type 1 Diabetes|
|Actual Study Start Date :||April 18, 2016|
|Actual Primary Completion Date :||November 28, 2018|
|Actual Study Completion Date :||February 1, 2021|
Experimental: Hybrid closed loop
All subjects will be wearing the MMT-670G insulin pump, using it with the closed loop algorithm
Device: Insulin Pump
Closed Loop Algorithm
Other Name: MMT-670G
- Age 2-13 Years Old Subjects Change in A1C [ Time Frame: Baseline and end of 3-month study period ]Descriptive analysis of change in A1C from baseline to end of 3-month study period
- Age 2-13 Years Old Subjects Mean Change in % of Time in Euglycemia (70-180 mg/dL) [ Time Frame: baseline and 3 months ]mean change in % of time in Euglycemia (70-180 mg/dL) from baseline to 3 months study period
- Age 2-13 Years Old Subjects Mean Change in % of Time in Hyperglycemia (> 180 mg/dL) [ Time Frame: baseline and 3 months ]mean change in % of time in hyperglycemia (> 180 mg/dL) from baseline to 3 months study period
- Age 2-13 Years Old Subjects Mean Change in % of Time in Hypoglycemia (<70 mg/dL) [ Time Frame: baseline and 3 months ]mean change in % of time in hypoglycemia (< 70 mg/dL) from baseline to 3 months study period
- Age 2-13 Years Old - Number of Severe Hypoglycemic Event [ Time Frame: 3 months ]Number of severe hypoglycemic events occurred during 3-month study period.
- Age 2-13 Years Old - Number of Diabetic Ketoacidosis (DKA) Event [ Time Frame: 3 months ]Number of Diabetic Ketoacidosis (DKA) events occurred during 3-month study period.
- Age 7-13 Years Old Subjects PLGM Performance - Event Rate Without Hypoglycemia at YSI-FST <=65 mg/dL [ Time Frame: Up to 12 hours after the start of PLGM period ]Event rate without Hypoglycemia at YSI-FST <=65 mg/dL among 105 subjects who underwent the PLGM experiments. The event rate without hypoglycemia is the number of experiments without hypoglycemia/total number of experiments and hypoglycemic events are defined based on the occurrence of 2 or more continuous YSI-FST <= 65mg/dL during in-clinic procedures.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660827
|United States, California|
|Escondido, California, United States, 92025|
|Stanford Hospital and Clinics|
|Palo Alto, California, United States, 94305|
|Torrance, California, United States, 90505|
|United States, Colorado|
|Barbara Davis Center|
|Aurora, Colorado, United States, 80045|
|United States, Florida|
|Nemours Children's Clinic|
|Jacksonville, Florida, United States, 32207|
|University of South Florida - USF Health|
|Tampa, Florida, United States, 33620|
|United States, Georgia|
|Atlanta Diabetes Associates|
|Atlanta, Georgia, United States, 30318|
|United States, Idaho|
|Rocky Mountain Diabetes and Osteoporosis Center|
|Idaho Falls, Idaho, United States, 83404|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Sheba Medical Center|
|Tel Aviv, Israel|