The purpose of this study is to obtain clinical data in Chinese patients to support product registration of the MiniMed™ 670G system with the National Medical Product Administration (NMPA) in China. The results from the study will be submitted to the NMPA for product registration.
This study is a multi-center, single arm study in insulin-requiring subjects with type 1 diabetes who are 14 years of age and older. The run-in period will be approximately up to 35 days long, followed by a study period that will be approximately up to 33 days in duration. The study is anticipated to last no longer than 13 months from investigational center initiation to completion of all data entry and monitoring procedures. The study will target approximately 5 months to complete subject enrollment. Subjects can expect to participate for approximately 2-3 months including the run-in and study periods. A total of up to 75 subjects (aged 14-75) will be enrolled at a minimum 2 investigational centers and up to 6 investigational centers (hospitals) in China to have at least 50 subjects who complete the study. The MiniMed™ HCL system that was employed in this study was the MiniMed™ 670G Bluetooth version (MMT-1883). The MiniMed™ 670G system with Bluetooth™ technology is the MiniMed™ 770G system.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Hybrid closed loop insulin pump with associated CGM and blood glucose meter
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Change in Time in Target Range (% of Sensor Glucose (SG)): 70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L)
The overall mean change in % of time in target range from run-in period to study period will be estimated and compared by a simple superiority paired test and a significance level of 0.025 (one-sided).
Time frame: Baseline to end of 1-month study
Time in Hypoglycemic Range
Time in hypoglycemic range (% of SG): SG \< 70 mg/dL (3.9 mmol/L), SG \< 60 mg/dL (3.3 mmol/L), SG \< 54 mg/dL (3.0 mmol/L) will be summarized.
Time frame: 1-month study
Time in Hyperglycemic Range: SG > 180 mg/dL (10 mmol/L), 250 mg/dL (13.9 mmol/L) and 350 mg/dL (19.4 mmol/L)
Time in hyperglycemic range (SG \> 180 mg/dL (10 mmol/L), 250 mg/dL (13.9 mmol/L) and 350 mg/dL (19.4 mmol/L)) will be summarized.
Time frame: 1-month study
Standard Deviation (SD) of SG in mmol/L
In order to evaluate glucose variation, we calculated standard deviation. The standard deviation (SD) of SG will be summarized in the unit of mmol/L
Time frame: 1-month study
Standard Deviation (SD) of SG in mg/dL
In order to evaluate glucose variation, we calculated standard deviation. The standard deviation (SD) of SG will be summarized in the unit of mg/dL.
Time frame: 1-month study
Coefficient of Variation (CV) of SG
In order to evaluate glucose variation, we calculated coefficient of variation (CV) of SG. The glucose coefficient of variation (CV) will be summarized in percentage.
Time frame: 1-month study
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Change of Total Daily Dose (TDD) of Insulin From Baseline to End of Study (EOS)
Change of Total Daily Dose (TDD) of insulin from baseline to EOS will be summarized.
Time frame: Baseline to end of 1-month study
Change of Weight From Baseline to EOS
Change of weight from baseline to EOS will be summarized.
Time frame: Baseline to end of 1-month study
Time Spent in Auto Mode (HCL) Versus Time Spent in Manual Mode (Open Loop)
Time spent in Auto Mode (HCL) and time spent in Manual Mode (open loop) will be summarized.
Time frame: 1-month study
Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%)
Time in target range (% of SG): 70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L) in study period Time in hypoglycemic range (% of SG): SG \< 70 mg/dL (3.9 mmol/L), 60 mg/dL (3.3 mmol/L) and 54 mg/dL (3.0 mmol/L) in study period Time in hyperglycemic range: SG \> 180 mg/dL (10 mmol/L), 250 mg/dL (13.9 mmol/L) and 350 mg/dL (19.4 mmol/L) in study period
Time frame: 1-month study