PMID- 25188375 OWN - NLM STAT- MEDLINE DCOM- 20150715 LR - 20211021 IS - 1557-8593 (Electronic) IS - 1520-9156 (Print) IS - 1520-9156 (Linking) VI - 16 IP - 10 DP - 2014 Oct TI - Multicenter closed-loop/hybrid meal bolus insulin delivery with type 1 diabetes. PG - 623-32 LID - 10.1089/dia.2014.0050 [doi] AB - BACKGROUND: This study evaluated meal bolus insulin delivery strategies and associated postprandial glucose control while using an artificial pancreas (AP) system. SUBJECTS AND METHODS: This study was a multicenter trial in 53 patients, 12-65 years of age, with type 1 diabetes for at least 1 year and use of continuous subcutaneous insulin infusion for at least 6 months. Four different insulin bolus strategies were assessed: standard bolus delivered with meal (n=51), standard bolus delivered 15 min prior to meal (n=40), over-bolus of 30% delivered with meal (n=40), and bolus purposely omitted (n=46). Meal carbohydrate (CHO) intake was 1 g of CHO/kg of body weight up to a maximum of 100 g for the first three strategies or up to a maximum of 50 g for strategy 4. RESULTS: Only three of 177 meals (two with over-bolus and one with standard bolus 15 min prior to meal) had postprandial blood glucose values of <60 mg/dL. Postprandial hyperglycemia (blood glucose level >180 mg/dL) was prolonged for all four bolus strategies but was shorter for the over-bolus (41% of the 4-h period) than the two standard bolus strategies (73% for each). Mean postprandial blood glucose level was 15.9 mg/dL higher for the standard bolus with meal compared with the prebolus (baseline-adjusted, P=0.07 for treatment effect over the 4-h period). CONCLUSIONS: The AP handled the four bolus situations safely, but at the expense of having elevated postprandial glucose levels in most subjects. This was most likely secondary to suboptimal performance of the algorithm. FAU - Chase, H Peter AU - Chase HP AD - 1 Barbara Davis Center for Childhood , Aurora, Colorado. FAU - Doyle, Francis J 3rd AU - Doyle FJ 3rd FAU - Zisser, Howard AU - Zisser H FAU - Renard, Eric AU - Renard E FAU - Nimri, Revital AU - Nimri R FAU - Cobelli, Claudio AU - Cobelli C FAU - Buckingham, Bruce A AU - Buckingham BA FAU - Maahs, David M AU - Maahs DM FAU - Anderson, Stacey AU - Anderson S FAU - Magni, Lalo AU - Magni L FAU - Lum, John AU - Lum J FAU - Calhoun, Peter AU - Calhoun P FAU - Kollman, Craig AU - Kollman C FAU - Beck, Roy W AU - Beck RW CN - Control to Range Study Group LA - eng SI - ClinicalTrials.gov/NCT01271023 PT - Evaluation Study PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20140904 PL - United States TA - Diabetes Technol Ther JT - Diabetes technology & therapeutics JID - 100889084 RN - 0 (Blood Glucose) RN - 0 (Dietary Carbohydrates) RN - 0 (Hypoglycemic Agents) SB - IM MH - Adolescent MH - Adult MH - Algorithms MH - Blood Glucose/*metabolism MH - Blood Glucose Self-Monitoring MH - Child MH - Diabetes Mellitus, Type 1/blood/*drug therapy MH - Dietary Carbohydrates/metabolism MH - Female MH - Humans MH - Hyperglycemia/*drug therapy/prevention & control MH - Hypoglycemic Agents/administration & dosage/*metabolism MH - *Insulin Infusion Systems MH - Male MH - *Meals MH - Middle Aged MH - *Pancreas, Artificial MH - Patient Compliance MH - Postprandial Period MH - United States PMC - PMC4183919 FIR - Zisser, Howard IR - Zisser H FIR - Jovanovic, Lois IR - Jovanovic L FIR - Wollitzer, Alison IR - Wollitzer A FIR - Bevier, Wendy IR - Bevier W FIR - Dassau, Eyal IR - Dassau E FIR - Castorino, Kristin IR - Castorino K FIR - Markova, Kateryna IR - Markova K FIR - Wiley, Jacqueline IR - Wiley J FIR - Beveridge, Erin IR - Beveridge E FIR - Santibanez, Nicolas IR - Santibanez N FIR - Sales, Alexandra IR - Sales A FIR - Bradley, Maia IR - Bradley M FIR - Castorino, Adam IR - Castorino A FIR - Kovatchev, Boris IR - Kovatchev B FIR - Anderson, Stacey IR - Anderson S FIR - Demartini, Susan IR - Demartini S FIR - Brown, Sue IR - Brown S FIR - Clarke, William IR - Clarke W FIR - Breton, Marc IR - Breton M FIR - Patek, Stephen IR - Patek S FIR - Keith-Hynes, Patrick IR - Keith-Hynes P FIR - Hughes-Karvetski, Colleen IR - Hughes-Karvetski C FIR - McElwee, Molly IR - McElwee M FIR - Oliveri, Mary IR - Oliveri M FIR - Wakeman, Christian IR - Wakeman C FIR - Renard, Eric IR - Renard E FIR - Farret, Anne IR - Farret A FIR - Pelletier, Marie-Josee IR - Pelletier MJ FIR - Chevassus, Hugues IR - Chevassus H FIR - Place, Jerome IR - Place J FIR - Phillip, Moshe IR - Phillip M FIR - Atlas, Eran IR - Atlas E FIR - Nimri, Revital IR - Nimri R FIR - Oron, Tal IR - Oron T FIR - Farfel, Alon IR - Farfel A FIR - Demol, Sharon IR - Demol S FIR - Mel, Eran IR - Mel E FIR - Ben-Ari, Tal IR - Ben-Ari T FIR - Gilon, Michael IR - Gilon M FIR - Parnes, Ayele IR - Parnes A FIR - Muller, Ido IR - Muller I FIR - Miller, Shahar IR - Miller S FIR - Hamou, Alona IR - Hamou A FIR - Hermon, Orna IR - Hermon O FIR - Shiovitch-Mantzuri, Galit IR - Shiovitch-Mantzuri G FIR - Fayman, Galia IR - Fayman G FIR - Cobelli, Claudio IR - Cobelli C FIR - Dalla Man, Chiara IR - Dalla Man C FIR - Avogaro, Angelo IR - Avogaro A FIR - Bruttomesso, Daniela IR - Bruttomesso D FIR - Maran, Alberto IR - Maran A FIR - Schiavon, Michele IR - Schiavon M FIR - Del Favero, Simone IR - Del Favero S FIR - Visentin, Roberto IR - Visentin R FIR - Scotton, Rachele IR - Scotton R FIR - Filippi, Alessio IR - Filippi A FIR - Magni, Lalo IR - Magni L FIR - Toffanin, Chiara IR - Toffanin C FIR - De Nicolao, Giuseppe IR - De Nicolao G FIR - Mancini, Simone IR - Mancini S FIR - Raimondo, Davide Martino IR - Raimondo DM FIR - Buckingham, Bruce IR - Buckingham B FIR - Wilson, Darrell M IR - Wilson DM FIR - Benassi, Kari IR - Benassi K FIR - Clinton, Paula IR - Clinton P FIR - Harris, Breanne P IR - Harris BP FIR - Shanmugham, Satya IR - Shanmugham S FIR - Caswell, Kimberly IR - Caswell K FIR - Chase, H Peter IR - Chase H FIR - Maahs, David M IR - Maahs DM FIR - Slover, Robert IR - Slover R FIR - Sullivan, Sally IR - Sullivan S FIR - Messer, Laurel IR - Messer L FIR - Gage, Victoria IR - Gage V FIR - Realsen, Jaime IR - Realsen J FIR - Westfall, Emily IR - Westfall E FIR - Goettle, Hannah IR - Goettle H FIR - Doyle, Francis J 3rd IR - Doyle FJ 3rd FIR - Beck, Roy W IR - Beck RW FIR - Lum, John IR - Lum J FIR - Kollman, Craig IR - Kollman C FIR - Calhoun, Peter IR - Calhoun P FIR - Sibayan, Judy IR - Sibayan J FIR - Njeru, Nelly M IR - Njeru NM FIR - Sauer, Werner IR - Sauer W FIR - Pickup, John C IR - Pickup JC FIR - Hirsch, Irl IR - Hirsch I FIR - Wolpert, Howard IR - Wolpert H EDAT- 2014/09/05 06:00 MHDA- 2015/07/16 06:00 PMCR- 2015/10/01 CRDT- 2014/09/05 06:00 PHST- 2014/09/05 06:00 [entrez] PHST- 2014/09/05 06:00 [pubmed] PHST- 2015/07/16 06:00 [medline] PHST- 2015/10/01 00:00 [pmc-release] AID - 10.1089/dia.2014.0050 [pii] AID - 10.1089/dia.2014.0050 [doi] PST - ppublish SO - Diabetes Technol Ther. 2014 Oct;16(10):623-32. doi: 10.1089/dia.2014.0050. Epub 2014 Sep 4.