The study objective is to demonstrate that home use of Threshold Suspend (TS) is not associated with glycemic deterioration in pediatric patients with type 1 diabetes, as measured by change in A1C.
This study is a longitudinal, multi-center trial that aims to observe the Threshold Suspend (TS) feature with a sensor-augmented insulin pump in patients 7-15 years with Type 1 diabetes. The study will measure the change in A1C from baseline over a period of one year while subjects are wearing the study pump.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
194
Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
Overall Mean Change in A1C
The overall mean change in A1C from baseline to 1 year will be estimated and compared by a non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided). Among the 136 subjects who completed the study, 132 had both baseline and end of study A1c. Therefore, primary endpoint was based on 132 subjects.
Time frame: Baseline and 1 year after screening
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c below 7%. Among the 132 subjects with both baseline and end of study A1c, 3 had A1c below 7%
Time frame: Baseline and 1 year after screening
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c 7% to 9%. Among the 132 subjects with both baseline and end of study A1c, 97 had A1c 7% to 9%
Time frame: Baseline and 1 year after screening
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c \> 9%. Among the 132 subjects with both baseline and end of study A1c, 32 had A1c \> 9%
Time frame: Baseline and 1 year after screening
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