Constructing an Artificial Pancreas
Multiday Outpatient Glycemic Control in Adolescents with Type 1 Diabetes Using a Bihormonal Bionic Pancreas: The Barton Center Summer Camp Study
6/15/2014 6:00:00 PM
6/15/2014 6:15:00 PM
, FIRAS H. EL-KHATIB, MANASI SINHA, KENDRA L. MAGYAR, KATHERINE MCKEON, LAURA G.. GOERGEN, MALLORY A. HILLARD, DAVID M. NATHAN, EDWARD R. DAMIANO,
The safety and effectiveness of automated glycemic control has not been demonstrated in multiday outpatient studies.
In a random-order cross-over study in a diabetes camp, 32 adolescents participated in five days of glycemic control with an automated bihormonal bionic pancreas and five days of control care with an insulin pump. Subjects were fully integrated into normal camp activities and meals without restrictions on diet or exercise. The bionic pancreas used data from a continuous glucose monitor (CGM) and an autonomously adaptive algorithm running on a smartphone to control subcutaneous delivery of insulin and glucagon. Plasma glucose (PG) levels measured by fingerstick and CGM levels, which were masked to subjects under usual care, were compared between the two study arms. The co-primary outcomes were difference in the average of scheduled plasma glucose (PG) measurements and percentage of these <70 mg/dl.
The mean PG level was 138±18 mg/dl (range 101-185 mg/dl) on the bionic pancreas and 157±27 mg/dl (range 103-221 mg/dl) in the control period (p=0.004). The percentage of all scheduled PG measurements with values <70 mg/dl was 6.1% during the bionic pancreas period and 7.6% during the control period (p=0.23). The bionic pancreas reduced the mean frequency of treatments for hypoglycemia from once per 0.8 days to once per 1.6 days (p<0.001) and increased time in the 70-180 mg/dl range (75.9±7.9 versus 64.5±14.1, p<0.001) by CGM.
A wearable, automated bihormonal bionic pancreas improved glycemia without increasing hypoglycemia in a multiday outpatient study in a diabetes camp.
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