Multicenter closed-loop/hybrid meal bolus insulin delivery with type 1 diabetes.

Publisher: Mary Ann Liebert, Inc Country of Publication: United States NLM ID: 100889084 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1557-8593 (Electronic) Linking ISSN: 15209156 NLM ISO Abbreviation: Diabetes Technol Ther Subsets: MEDLINE

Original Publication: Larchmont, NY : Mary Ann Liebert, Inc., c1999-

Insulin Infusion Systems* ; Meals* ; Pancreas, Artificial*; Blood Glucose/*metabolism ; Diabetes Mellitus, Type 1/*drug therapy ; Hyperglycemia/*drug therapy ; Hypoglycemic Agents/*metabolism; Adolescent ; Adult ; Algorithms ; Blood Glucose Self-Monitoring ; Child ; Diabetes Mellitus, Type 1/blood ; Dietary Carbohydrates/metabolism ; Female ; Humans ; Hyperglycemia/prevention & control ; Hypoglycemic Agents/administration & dosage ; Male ; Middle Aged ; Patient Compliance ; Postprandial Period ; United States

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.

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Investigator: H Zisser; L Jovanovic; A Wollitzer; W Bevier; E Dassau; K Castorino; K Markova; J Wiley; E Beveridge; N Santibanez; A Sales; M Bradley; A Castorino; B Kovatchev; S Anderson; S Demartini; S Brown; W Clarke; M Breton; S Patek; P Keith-Hynes; C Hughes-Karvetski; M McElwee; M Oliveri; C Wakeman; E Renard; A Farret; MJ Pelletier; H Chevassus; J Place; M Phillip; E Atlas; R Nimri; T Oron; A Farfel; S Demol; E Mel; T Ben-Ari; M Gilon; A Parnes; I Muller; S Miller; A Hamou; O Hermon; G Shiovitch-Mantzuri; G Fayman; C Cobelli; C Dalla Man; A Avogaro; D Bruttomesso; A Maran; M Schiavon; S Del Favero; R Visentin; R Scotton; A Filippi; L Magni; C Toffanin; G De Nicolao; S Mancini; DM Raimondo; B Buckingham; DM Wilson; K Benassi; P Clinton; BP Harris; S Shanmugham; K Caswell; H Chase; DM Maahs; R Slover; S Sullivan; L Messer; V Gage; J Realsen; E Westfall; H Goettle; FJ Doyle; RW Beck; J Lum; C Kollman; P Calhoun; J Sibayan; NM Njeru; W Sauer; JC Pickup; I Hirsch; H Wolpert

ClinicalTrials.gov NCT01271023

0 (Blood Glucose)
0 (Dietary Carbohydrates)
0 (Hypoglycemic Agents)

Date Created: 20140905 Date Completed: 20150715 Latest Revision: 20211021

20240628

PMC4183919

10.1089/dia.2014.0050

25188375