Two of the major problems in attaining euglycemia in subjects with type 1 diabetes (T1D) arehypoglycemia (including fear of severe hypoglycemia) and post-meal hyperglycemia. The lattercommonly occurs in adolescents secondary to missed meal and snack insulin boluses. Both ofthese issues will be addressed over the five years of this grant. As over half of severehypoglycemic events occur during sleep, we will continue our development of algorithms topredict and prevent nocturnal hypoglycemia using a closed loop system (CLS) in which theinformation from a continuous glucose monitor (CGM) is used to suspend delivery of insulin byan insulin pump. Initial studies will be done in the Clinical Translational Research Centers(CTRCs) to document safety of the 'Florence' CLS (Abbott Diabetes Care) and we will thenconduct a randomized clinical trial in the home environment in years 2 and 3 of the grant.Similarly, a fully portable CLS will be used to detect and correct hyperglycemia resulting frommissed food boluses. The safety and efficacy of algorithms which utilize the signal form a CGMand provide output to an insulin pump will initially be studied in the CTRC's in year 3 of thegrant. In years 4 and 5 of this grant we plan to assess the combined algorithms for preventionof hypoglycemia and hyperglycemia in a fully ambulatory system developed by Abbott DiabetesCare. We believe that prevention of hypoglycemia, particularly at night, and reduction of postprandial hyperglycemia will result in improvement in glycemic control and reduction in HbA1clevels.

Public Health Relevance

Hypoglycemia is one of the main deterrents for attaining optimal glycemic control for people with type 1 diabetes. This research is focused on reducing hypoglycemia as well as hyperglycemia after meals in people with type 1 diabetes. Hopefully this will lead to improved glycemic control for participants.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
5R01DK085591-03
Application #
8137658
Study Section
Special Emphasis Panel (ZDK1-GRB-2 (O2))
Program Officer
Arreaza-Rubin, Guillermo
Project Start
2009-09-30
Project End
2014-08-31
Budget Start
2011-09-01
Budget End
2012-08-31
Support Year
3
Fiscal Year
2011
Total Cost
$731,221
Indirect Cost
Name
Jaeb Center for Health Research, Inc.
Department
Type
DUNS #
957043193
City
Tampa
State
FL
Country
United States
Zip Code
33647
Spaic, Tamara; Driscoll, Marsha; Raghinaru, Dan et al. (2017) Predictive Hyperglycemia and Hypoglycemia Minimization: In-Home Evaluation of Safety, Feasibility, and Efficacy in Overnight Glucose Control in Type 1 Diabetes. Diabetes Care 40:359-366
Calhoun, Peter M; Buckingham, Bruce A; Maahs, David M et al. (2016) Efficacy of an Overnight Predictive Low-Glucose Suspend System in Relation to Hypoglycemia Risk Factors in Youth and Adults With Type 1 Diabetes. J Diabetes Sci Technol 10:1216-1221
Wadwa, R Paul; Chase, H Peter; Raghinaru, Dan et al. (2016) Ketone production in children with type 1 diabetes, ages 4-14 years, with and without nocturnal insulin pump suspension. Pediatr Diabetes :
Wilson, Darrell M; Calhoun, Peter M; Maahs, David M et al. (2015) Factors associated with nocturnal hypoglycemia in at-risk adolescents and young adults with type 1 diabetes. Diabetes Technol Ther 17:385-91
Buckingham, Bruce A; Raghinaru, Dan; Cameron, Fraser et al. (2015) Predictive Low-Glucose Insulin Suspension Reduces Duration of Nocturnal Hypoglycemia in Children Without Increasing Ketosis. Diabetes Care 38:1197-204
Beck, Roy W; Raghinaru, Dan; Wadwa, R Paul et al. (2014) Frequency of morning ketosis after overnight insulin suspension using an automated nocturnal predictive low glucose suspend system. Diabetes Care 37:1224-9
Bequette, B Wayne (2014) Fault detection and safety in closed-loop artificial pancreas systems. J Diabetes Sci Technol 8:1204-14
Maahs, David M; Calhoun, Peter; Buckingham, Bruce A et al. (2014) A randomized trial of a home system to reduce nocturnal hypoglycemia in type 1 diabetes. Diabetes Care 37:1885-91
Stenerson, Matthew; Cameron, Fraser; Wilson, Darrell M et al. (2014) The Impact of Accelerometer and Heart Rate Data on Hypoglycemia Mitigation in Type 1 Diabetes. J Diabetes Sci Technol 8:64-69
Baysal, Nihat; Cameron, Fraser; Buckingham, Bruce A et al. (2014) A novel method to detect pressure-induced sensor attenuations (PISA) in an artificial pancreas. J Diabetes Sci Technol 8:1091-6

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