Two of the major problems in attaining euglycemia in subjects with type 1 diabetes (T1D) are hypoglycemia (including fear of severe hypoglycemia) and post-meal hyperglycemia. The latter commonly occurs in adolescents secondary to missed-meal and snack insulin boluses. Both of these issues will be addressed over the five years of this grant. As over half of severe hypoglycemic events occur during sleep, we will continue our development of algorithms to predict and prevent nocturnal hypoglycemia using a closed-loop system (CLS) in which the information from a continuous glucose monitor (CGM) is used to suspend delivery of insulin by an 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 then conduct 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 from missed food boluses. The safety and efficacy of algorithms which utilize the signal form a CGM and provide output to an insulin pump will initially be studied in the CTRC's in year 3 of the grant. In years 4 and 5 of this grant we plan to assess the combined algorithms for prevention of hypoglycemia and hyperglycemia in a fully ambulatory system developed by Abbott Diabetes Care. We believe that prevention of hypoglycemia, particularly at night, and reduction of post prandial hyperglycemia will result in improvement in glycemic control and reduction in HbA1c levels.

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 #
3R01DK085591-02S1
Application #
8207373
Study Section
Special Emphasis Panel (ZDK1-GRB-2 (O2))
Program Officer
Arreaza-Rubin, Guillermo
Project Start
2009-09-30
Project End
2012-08-31
Budget Start
2010-09-01
Budget End
2011-08-31
Support Year
2
Fiscal Year
2011
Total Cost
$114,021
Indirect Cost
Name
Jaeb Center for Health Research, Inc.
Department
Type
DUNS #
957043193
City
Tampa
State
FL
Country
United States
Zip Code
33647
Forlenza, Gregory P; Raghinaru, Dan; Cameron, Faye et al. (2018) Predictive hyperglycemia and hypoglycemia minimization: In-home double-blind randomized controlled evaluation in children and young adolescents. Pediatr Diabetes 19:420-428
Wadwa, R Paul; Chase, H Peter; Raghinaru, Dan et al. (2017) Ketone production in children with type 1 diabetes, ages 4-14 years, with and without nocturnal insulin pump suspension. Pediatr Diabetes 18:422-427
Messer, Laurel H; Calhoun, Peter; Buckingham, Bruce et al. (2017) In-home nighttime predictive low glucose suspend experience in children and adults with type 1 diabetes. Pediatr Diabetes 18:332-339
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
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
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
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
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

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