Threshold-Based Insulin-Pump Interruption for Reduction of Hypoglycemia

Bergenstal, Richard M.; Klonoff, David C.; Garg, Satish K.; Bode, Bruce W.; Meredith, Melissa; Slover, Robert H.; Ahmann, Andrew J.; Welsh, John; Lee, Scott W.; Kaufman, Francine

doi:10.1056/nejmoa1303576

Cited by 610 publications

(430 citation statements)

References 19 publications

Supporting

Mentioning

388

Contrasting

Unclassified

Order By: Relevance

“…Trends towards reductions in the occurrence of mild and severe hypoglycaemic events when using such combinations have been reported [35,36] but also challenged [37]. These represent an intermediate step towards automated insulin delivery (AID) systems [38].…”

Section: Combination Of Cgm With Insulin Pumps: Automated Insulin Delmentioning

confidence: 99%

Improving the clinical value and utility of CGM systems: issues and recommendations

et al. 2017

Self Cite

View full text Add to dashboard Cite

The first systems for continuous glucose monitoring (CGM) became available over 15 years ago. Many then believed CGM would revolutionise the use of intensive insulin therapy in diabetes; however, progress towards that vision has been gradual. Although increasing, the proportion of individuals using CGM rather than conventional systems for self-monitoring of blood glucose on a daily basis is still low in most parts of the world. Barriers to uptake include cost, measurement reliability (particularly with earlier-generation systems), human factors issues, lack of a standardised format for displaying results and uncertainty on how best to use CGM data to make therapeutic decisions. This scientific statement makes recommendations for systemic improvements in clinical use and regulatory (pre-and postmarketing) handling of CGM devices. The aim is to improve safety and efficacy in order to support the advancement of the technology in achieving its potential to improve quality of life and health outcomes for more people with diabetes.

show abstract

Section: Combination Of Cgm With Insulin Pumps: Automated Insulin Delmentioning

confidence: 99%

Improving the clinical value and utility of CGM systems: issues and recommendations

et al. 2017

Self Cite

View full text Add to dashboard Cite

show abstract

“…The evidence from multicenter randomized controlled [20,23], (Table 1, and nonrandomized studies [45] including children and adolescents in real-life settings is that automated insulin suspension is safe and reduces the frequency and duration of overall and nocturnal hypoglycemic episodes compared to insulin pump therapy [23] or sensor augmented pump therapy [20,45]. The threshold-based suspend feature was shown to reduce the percentage of time spent with blood glucose levels in the hypoglycemic range overnight [20,23], and to reduce the overall risk of severe and moderate hypoglycemia in those with highest risk, including those with impaired hypoglycemia awareness and the highest frequency of severe hypoglycemia [23].…”

Section: Glucose Responsive Suspension Of Insulin Deliverymentioning

confidence: 99%

“…The threshold-based suspend feature was shown to reduce the percentage of time spent with blood glucose levels in the hypoglycemic range overnight [20,23], and to reduce the overall risk of severe and moderate hypoglycemia in those with highest risk, including those with impaired hypoglycemia awareness and the highest frequency of severe hypoglycemia [23]. …”

Section: Glucose Responsive Suspension Of Insulin Deliverymentioning

confidence: 99%

“…Periodic insulin suspension over up to 2 h did not result in elevated glucose concentration as indicated by similar average glucose levels and HbA1c levels over a period of 3-6 months compared to insulin pump therapy and sensor augmented pump therapy [20,23]. …”

Section: Glucose Responsive Suspension Of Insulin Deliverymentioning

confidence: 99%

“…Threshold-based suspend and predictive low glucose management insulin pump therapy are the first commercial predecessors of closed-loop technology [20,21] followed by the first hybrid closed-loop system approved for the non-pediatric population [22]. …”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Insulin delivery and nocturnal glucose control in children and adolescents with type 1 diabetes

Tauschmann

Hovorka

2017

Expert Opinion on Drug Delivery

View full text Add to dashboard Cite

Introduction: Nocturnal glucose control remains challenging in children and adolescents with type 1 diabetes due to highly variable overnight insulin requirements. The issue may be addressed by glucose responsive insulin delivery based on real-time continuous glucose measurements.Areas covered: This review outlines recent developments of glucose responsive insulin delivery systems from a paediatric perspective. We cover threshold-based suspend application, predictive low glucose suspend, and more advanced single hormone and dual-hormone closed-loop systems. Approaches are evaluated in relation to nocturnal glucose control particularly during outpatient randomised controlled trials.Expert opinion: Significant progress translating research from controlled clinical centre settings to free-living unsupervised home studies have been achieved over the past decade. Nocturnal glycaemic control can be improved whilst reducing the risk of hypoglycaemia with closed-loop systems. Following the US regulatory approval of the first hybrid closed-loop system in non-paediatric population, large multinational closed-loop clinical trials and pivotal studies including paediatric populations are underway or in preparation to facilitate the use of closed-loop systems in clinical practice.

show abstract

Effect of Sensor-Augmented Insulin Pump Therapy and Automated Insulin Suspension vs Standard Insulin Pump Therapy on Hypoglycemia in Patients With Type 1 Diabetes

Nicholas

Retterath

et al. 2013

JAMA

395

290

View full text Add to dashboard Cite

IMPORTANCE 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.OBJECTIVE To determine the incidence of severe and moderate hypoglycemia with sensor-augmented pump with low-glucose suspension compared with standard insulin pump therapy. DESIGN, SETTING, AND PARTICIPANTSA randomized clinical trial involving 95 patients with type 1 diabetes, recruited from December 2009 to January 2012 in Australia.INTERVENTIONS Patients were randomized to insulin pump only or automated insulin suspension for 6 months. MAIN OUTCOMES AND MEASURESThe 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. RESULTSOf 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.CONCLUSIONS AND RELEVANCE Sensor-augmented pump therapy with automated insulin suspension reduced the combined rate of severe and moderate hypoglycemia in patients with type 1 diabetes.

show abstract

Threshold-Based Insulin-Pump Interruption for Reduction of Hypoglycemia

Abstract: This study showed that over a 3-month period the use of sensor-augmented insulin-pump therapy with the threshold-suspend feature reduced nocturnal hypoglycemia, without increasing glycated hemoglobin values. (Funded by Medtronic MiniMed; ASPIRE ClinicalTrials.gov number, NCT01497938.).

Cited by 610 publications

References 19 publications

Improving the clinical value and utility of CGM systems: issues and recommendations

Improving the clinical value and utility of CGM systems: issues and recommendations

Insulin delivery and nocturnal glucose control in children and adolescents with type 1 diabetes

Effect of Sensor-Augmented Insulin Pump Therapy and Automated Insulin Suspension vs Standard Insulin Pump Therapy on Hypoglycemia in Patients With Type 1 Diabetes

Contact Info

Product

Resources

About