Clinical performance of three bolus calculators in subjects with type 1 diabetes mellitus: a head-to-head-to-head comparison.
BACKGROUND
Insulin pump systems now provide automated bolus calculators (ABCs) that electronically calculate insulin boluses to address carbohydrate intake and out-of-range blood glucose (bG) levels. We compared the efficacy of three ABCs (Accu-Chek(®) Combo [Roche Insulin Delivery Systems (IDS), Inc., Fishers, IN, a member of the Roche Group], Animas(®) 2020 [Animas Corp., West Chester, PA, a Johnson and Johnson company], and MiniMed Paradigm Bolus Wizard(®) [Medtronic MiniMed, Northridge, CA]) to safely reduce postprandial hyperglycemia in type 1 diabetes mellitus (T1DM).


METHODS
T1DM subjects (n = 24) were recruited at a single center for a prospective, triple crossover study. ABCs with the programmed target range (80-140 mg/dL) were used in random order. Postprandial hyperglycemia was induced by reducing the calculated bolus by 25%. Two hours after test meals, the ABCs were allowed to determine whether a correction bolus was needed. Differences between 6-h bG values after test meals that achieved 2-h postprandial hyperglycemia and the mean of the target range (110 mg/dL) were determined.


RESULTS
The mean difference between 6-h bG levels following test meals and the 110 mg/dL bG target with the MiniMed device (47.4 ± 31.8 mg/dL) was significantly higher than the Animas (17.3 ± 30.9 mg/dL) and Roche IDS (18.8 ± 33.8 mg/dL) devices (P = 0.0022 and P = 0.0049, respectively). The number of meals with 2-h postprandial hyperglycemia and bG levels at 2 h was similar. Roche IDS and Animas devices recommended correction boluses significantly (P = 0.0001 and P = 0.0002, respectively) more frequently than the MiniMed device. ABC use was not associated with severe hypoglycemia. There was no significant difference in the rate of mild hypoglycemia (bG <60 mg/dL not requiring assistance) among the three groups (Roche IDS and Animas, n = 2; MiniMed, n = 0).


CONCLUSIONS
In this study, the Roche IDS and Animas devices were more efficacious in controlling postprandial hyperglycemia than the MiniMed device. This may be due, in part, to differences in ABC setup protocols and algorithms. Use of ABCs can assist in controlling postprandial glycemia without significant hypoglycemia.
Sansum Diabetes Research Institute, Santa Barbara, CA, USA.
Howard
H
Zisser
Robin
R
Wagner
Stefan
S
Pleus
Cornelia
C
Haug
Nina
N
Jendrike
Chris
C
Parkin
Matthias
M
Schweitzer
Guido
G
Freckmann
D000328:Adult; D000465:Algorithms; D001786:Blood Glucose / Q000378:metabolism; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D006943:Hyperglycemia / Q000097:blood / Q000188:drug therapy*; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D015918:Infusion Pumps, Implantable; D007328:Insulin / Q000008:administration & dosage*; D007332:Insulin Infusion Systems; D008875:Middle Aged; D011446:Prospective Studies; D018709:Statistics, Nonparametric
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin