Early Detection of Insulin Deprivation in Continuous Subcutaneous Insulin Infusion-Treated Patients with Type 1 Diabetes

Orsini-Federici, M.; Akwi, J Akwe; Canonico, Valentina; Celleno, Roberta; Ferollà, Piero; Pippi, Roberto; Tassi, C; Timi, Alessandra; Benedetti, M. Massi

doi:10.1089/dia.2006.8.67

Cited by 32 publications

(20 citation statements)

References 13 publications

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“…It would also be unlikely using the current protocol that the duration of hypoglycemia would be long enough to result in a severe hypoglycemic episode. Previous studies have shown that suspension of insulin delivery for up to 2 h has not resulted in significant ketosis (10,21–25). In our studies, there was mild ketosis on four occasions when the pump was suspended for 90–180 min, and in each instance serum ketone levels returned to normal with the reinstitution of basal insulin therapy.…”

Section: Discussionmentioning

confidence: 98%

Prevention of Nocturnal Hypoglycemia Using Predictive Alarm Algorithms and Insulin Pump Suspension

et al. 2010

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OBJECTIVEThe aim of this study was to develop a partial closed-loop system to safely prevent nocturnal hypoglycemia by suspending insulin delivery when hypoglycemia is predicted in type 1 diabetes.RESEARCH DESIGN AND METHODSForty subjects with type 1 diabetes (age range 12–39 years) were studied overnight in the hospital. For the first 14 subjects, hypoglycemia (<60 mg/dl) was induced by gradually increasing the basal insulin infusion rate (without the use of pump shutoff algorithms). During the subsequent 26 patient studies, pump shutoff occurred when either three of five (n = 10) or two of five (n = 16) algorithms predicted hypoglycemia based on the glucose levels measured with the FreeStyle Navigator (Abbott Diabetes Care).RESULTSThe standardized protocol induced hypoglycemia on 13 (93%) of the 14 nights. With use of a voting scheme that required three algorithms to trigger insulin pump suspension, nocturnal hypoglycemia was prevented during 6 (60%) of 10 nights. When the voting scheme was changed to require only two algorithms to predict hypoglycemia to trigger pump suspension, hypoglycemia was prevented during 12 (75%) of 16 nights. In the latter study, there were 25 predictions of hypoglycemia because some subjects had multiple hypoglycemic events during a night, and hypoglycemia was prevented for 84% of these events.CONCLUSIONSUsing algorithms to shut off the insulin pump when hypoglycemia is predicted, it is possible to prevent hypoglycemia on 75% of nights (84% of events) when it would otherwise be predicted to occur.

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Section: Discussionmentioning

confidence: 98%

Prevention of Nocturnal Hypoglycemia Using Predictive Alarm Algorithms and Insulin Pump Suspension

et al. 2010

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“…Our finding of infrequent ketonemia following pump suspension is consistent with prior studies that have shown that pump insulin delivery can be suspended for up to 5 h without producing significant ketonemia. [7][8][9] In studies of sensor-augmented pumps with a low glucose suspend feature (Paradigm VeoÔ; Medtronic Diabetes), no significant ketosis or ketoacidosis has been reported in thousands of 2-h nocturnal pump suspensions. [10][11][12][13] On intervention nights (algorithm operational), glucose levels tended to be lower on nights with pump suspension compared with nights without pump suspension, reflecting that there were lower glucose levels on nights triggering a suspension.…”

Section: Discussionmentioning

confidence: 99%

Outpatient Safety Assessment of an In-Home Predictive Low-Glucose Suspend System with Type 1 Diabetes Subjects at Elevated Risk of Nocturnal Hypoglycemia

Buckingham

Cameron

Calhoun

et al. 2013

Diabetes Technology & Therapeutics

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Objective: Nocturnal hypoglycemia is a common problem with type 1 diabetes. In the home setting, we conducted a pilot study to evaluate the safety of a system consisting of an insulin pump and continuous glucose monitor communicating wirelessly with a bedside computer running an algorithm that temporarily suspends insulin delivery when hypoglycemia is predicted. Research Design and Methods: After the run-in phase, a 21-night randomized trial was conducted in which each night was randomly assigned 2:1 to have either the predictive low-glucose suspend (PLGS) system active (intervention night) or inactive (control night). Three predictive algorithm versions were studied sequentially during the study for a total of 252 intervention and 123 control nights. The trial included 19 participants 18-56 years old with type 1 diabetes (hemoglobin A1c level of 6.0-7.7%) who were current users of the MiniMed Paradigm Ò REAL-Time RevelÔ System and Sof-sensor Ò glucose sensor (Medtronic Diabetes, Northridge, CA). Results: With the final algorithm, pump suspension occurred on 53% of 77 intervention nights. Mean morning glucose level was 144 -48 mg/dL on the 77 intervention nights versus 133 -57 mg/dL on the 37 control nights, with morning blood ketones >0.6 mmol/L following one intervention night. Overnight hypoglycemia was lower on intervention than control nights, with at least one value £70 mg/dL occurring on 16% versus 30% of nights, respectively, with the final algorithm. Conclusions: This study demonstrated that the PLGS system in the home setting is safe and feasible. The preliminary efficacy data appear promising with the final algorithm reducing nocturnal hypoglycemia by almost 50%.

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“…They investigated the validity of laboratory ketone measurement as a diagnostic tool in DKA. As already described, handheld ketone meters have been shown to be accurate when compared with laboratory methods between 0 and 3 mmol/l 4 13 16. The cut-off used for diagnosis of DKA was a β-HB ≥3 mmol/l, as this correlated well with a bicarbonate level ≤18 mEq/l, which features alongside cut-offs for pH, anion gap and glucose concentration in the DKA diagnostic consensus criteria in adults 17.…”

Section: Indications and Limitationsmentioning

confidence: 73%

“…In one study,16 eight adult type 1 diabetic patients underwent interruption of continuous subcutaneous insulin infusion (CSII) therapy. Mean capillary β-HB levels rose more rapidly than plasma glucose levels on CSII interruption (p<0.05), and fell more rapidly on reinstating CSII (p=0.03).…”

Section: Indications and Limitationsmentioning

confidence: 99%

How to use near-patient capillary ketone meters

Bashford

Acerini

2012

Arch Dis Child Educ Pract Ed

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Early Detection of Insulin Deprivation in Continuous Subcutaneous Insulin Infusion-Treated Patients with Type 1 Diabetes

Cited by 32 publications

References 13 publications

Prevention of Nocturnal Hypoglycemia Using Predictive Alarm Algorithms and Insulin Pump Suspension

Prevention of Nocturnal Hypoglycemia Using Predictive Alarm Algorithms and Insulin Pump Suspension

Outpatient Safety Assessment of an In-Home Predictive Low-Glucose Suspend System with Type 1 Diabetes Subjects at Elevated Risk of Nocturnal Hypoglycemia

How to use near-patient capillary ketone meters

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