Effect of Sensor-Augmented Insulin Pump Therapy and Automated Insulin Suspension vs Standard Insulin Pump Therapy on Hypoglycemia in Patients With Type 1 Diabetes
- 25 September 2013
- journal article
- research article
- Published by American Medical Association (AMA)
- Vol. 310 (12), 1240-7
- https://doi.org/10.1001/jama.2013.277818
Abstract
Hypoglycemia is a critical obstacle to the care of patients with type 1 diabetes. Sensor-augmented insulin pump with automated low-glucose insulin suspension has the potential to reduce the incidence of major hypoglycemic events. To determine the incidence of severe and moderate hypoglycemia with sensor-augmented pump with low-glucose suspension compared with standard insulin pump therapy. A randomized clinical trial involving 95 patients with type 1 diabetes, recruited from December 2009 to January 2012 in Australia. Patients were randomized to insulin pump only or automated insulin suspension for 6 months. The primary outcome was the combined incidence of severe (hypoglycemic seizure or coma) and moderate hypoglycemia (an event requiring assistance for treatment). In a subgroup, counterregulatory hormone responses to hypoglycemia were assessed using the hypoglycemic clamp technique. Of the 95 patients randomized, 49 were assigned to the standard-pump (pump-only) therapy and 46 to the low-glucose suspension group. The mean (SD) age was 18.6 (11.8) years; duration of diabetes, 11.0 (8.9) years; and duration of pump therapy, 4.1 (3.4) years. The baseline rate of severe and moderate hypoglycemic events in the pump-only group was 20.7 vs 129.6 events per 100 patient months in the low-glucose suspension group. After 6 months of treatment, the event rates decreased from 28 to 16 in the pump-only group vs 175 to 35 in the low-glucose suspension group. The adjusted incidence rate per 100 patient-months was 34.2 (95% CI, 22.0-53.3) for the pump-only group vs 9.5 (95% CI, 5.2-17.4) for the low-glucose suspension group. The incidence rate ratio was 3.6 (95% CI, 1.7-7.5; P <.001). There was no change in glycated hemoglobin in either group: mean, 7.4 (95% CI, 7.2-7.6) to 7.4 (95% CI, 7.2-7.7) in the pump-only group vs mean, 7.6 (95%, CI, 7.4-7.9) to 7.5 (95% CI, 7.3-7.7) in the low-glucose suspension group. Counterregulatory hormone responses to hypoglycemia were not changed. There were no episodes of diabetic ketoacidosis or hyperglycemia with ketosis. Sensor-augmented pump therapy with automated insulin suspension reduced the combined rate of severe and moderate hypoglycemia in patients with type 1 diabetes. anzctr.org.au Identifier: ACTRN12610000024044.Keywords
This publication has 18 references indexed in Scilit:
- Threshold-Based Insulin-Pump Interruption for Reduction of HypoglycemiaNew England Journal of Medicine, 2013
- Analysis of Glucose Responses to Automated Insulin Suspension With Sensor-Augmented Pump TherapyDiabetes Care, 2012
- Reduction in Duration of Hypoglycemia by Automatic Suspension of Insulin Delivery: The In-Clinic ASPIRE StudyDiabetes Technology & Therapeutics, 2012
- Prevention of Hypoglycemia by Using Low Glucose Suspend Function in Sensor-Augmented Pump TherapyDiabetes Technology & Therapeutics, 2011
- Usage and Effectiveness of the Low Glucose Suspend Feature of the Medtronic Paradigm Veo Insulin PumpJournal of Diabetes Science and Technology, 2011
- Impaired Awareness of Hypoglycemia in a Population-Based Sample of Children and Adolescents With Type 1 DiabetesDiabetes Care, 2009
- Prevalence of impaired awareness of hypoglycaemia in adults with Type 1 diabetesDiabetic Medicine, 2008
- Clinical characteristics of type 1 diabetic patients with and without severe hypoglycemia.Diabetes Care, 2000
- Prospective assessment of severe hypoglycaemia in diabetic children and adolescents with impaired and normal awareness of hypoglycaemiaDiabetologia, 1998
- Reduced Awareness of Hypoglycemia in Adults With IDDM: A prospective study of hypoglycemic frequency and associated symptomsDiabetes Care, 1995