The purpose of this study is to collect data on the feasibility of the HLCL system in a camp setting.
This study is a single-arm, single-center, in clinic Investigation in subjects with type 1 diabetes on insulin pump therapy. Run-in Period A total of up 10 subjects will be enrolled (age 18-25). A minimum of 6 days run-in period with the 640G (sensor augmented pump) will be used to collect sensors and insulin data and to allow the subject to become familiar. Study Period - Camp Following the run-in period subjects will participate in a 5 day, 4 night study period in an camp setting during which the CL feature will be studied. Subjects will receive 3 meals each day, one night they receive a high fat dinner, one morning they will receive breakfast high in carbohydrates. Subjects will be asked to exercise for up to 60 minutes on one day during their study period. Subjects will be asked to take a minimum of 5 fingersticks a day (before each meal, morning and before bedtime)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
All patients get to wear the pump
Descriptive endpoints
Time in different range SG 70 mg/dL ≤ SG ≤ 180 mg/dL
Time frame: after 4 days of camp
Descriptive endpoints
Serious Adverse Events (SAE)
Time frame: after 4 days of camp
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