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

Buckingham, Bruce A.; Chase, H. Peter; Dassau, Eyal; Cobry, Erin; Clinton, Paula; Gage, Victoria; Caswell, Kimberly; Wilkinson, John; Cameron, Fraser; Lee, Hyunjin; Bequette, B. Wayne; Doyle, Francis J.

doi:10.2337/dc09-2303

Cited by 151 publications

(121 citation statements)

References 27 publications

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“…The hypoglycemia prediction algorithm and automatic pump suspension (predictive low-glucose suspend [PLGS]) reduced the incidence of nocturnal hypoglycemia by about 75% on nights when hypoglycemia otherwise would have occurred. 5 The current study was designed to assess the safety of using PLGS and to provide preliminary efficacy data on reducing nocturnal hypoglycemia in an outpatient setting. An additional goal of these studies was to gain experience with changing some of the tunable parameters in the algorithm to determine the relative impact of these changes on measures of both hyperglycemia and hypoglycemia and to modify the hypoglycemia prediction horizon if necessary.…”

Section: Introductionmentioning

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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Section: Introductionmentioning

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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“…Newer pumps have built-in hypoglycemia alarm that alerts the patient if their blood glucose is going low, although the phenomenon of "alarm fatigue" have been reported, causing patients to unintentionally ignore their alarm warnings if occur too often (Buckingham et al, 2010). Regular blood glucose measurements are therefore still very important, in order to inform the patient of impending hypo-or hyperglycemia, thereby allowing them to take the necessary precaution or action.…”

Section: Disadvantages Of Csiimentioning

confidence: 99%

Insulin Pump Therapy in Type 1 Diabetes-Merging Technology with Diabetes Care

Thabit¹

2012

American Medical Journal

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Abstract:The use of insulin pump therapy has been increasing over the past number of years in many countries. The Diabetes Control and Complications Trial (DCCT) have proven that better glycaemic control with fewer hypoglycemic events is achievable with insulin pump therapy. The delivery of subcutaneous insulin through an insulin pump mimics physiological insulin delivery better than Multiple Daily Injection of insulin (MDI). Insulin pump therapy is an attractive therapeutic option for many patients with T1DM with the potential to improve glycaemic control and quality of life. Technological developments over the past few years have enhanced the functional capabilities and appearance of modern insulin pumps. Careful patient selection for insulin pump therapy by health care professionals is still important, to optimize its benefit and to lessen the associated risk. In this review article, the clinical evidence for insulin pumps, its advantages and disadvantages, as well as patient selection criteria for insulin pumps are outlined. Examples of insulin pump devices that are currently available, including the advent of newer devices and technology in this field are also reviewed.

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“…40 Predictive LGS systems can suspend insulin delivery when hypoglycemia is predicted, thus having the potential to reduce up to ~80% of hypoglycemic events. 54 Taking the automation of insulin delivery a step further, a number of "closed-loop" systems are currently undergoing clinical trials. These use control algorithms to control insulin delivery in response to sensor glucose.…”

Section: Automated Insulin Deliverymentioning

confidence: 99%

Technology to Reduce Hypoglycemia

Yeoh

Choudhary

2015

J Diabetes Sci Technol

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Hypoglycemia remains a major limiting factor toward the intensification of treatment for diabetes mellitus 1 and is a major cost to patients and to health care systems. 2 Hypoglycemia is often divided into mild or nonsevere hypoglycemia episodes (NSHE), where the person is able to selftreat, and severe hypoglycemia (SH), where external assistance is required. It is difficult to set a biochemical threshold for hypoglycemia, as the glucose threshold at which symptoms of hypoglycemia can be detected vary between individuals and even from day to day within the same person.3 The ADA workgroup on hypoglycemia offers some consensus guidelines, defining an alert value of ≤70 mg/dl, measured through self-monitored blood glucose (SMBG) or subcutaneous continuous glucose monitoring (CGM), as indicative of the potential for developing hypoglycemia. 4 All those treated with insulin secretagogues (sulphonylureas, glinides) and insulin therapy are at risk of hypoglycemia, and this risk is increased in the presence of endogenous insulin deficiency, longer duration of diabetes and longer duration of insulin therapy.5 Epidemiological data suggest that people with type 1 diabetes (T1D) with optimal glycemic control experience up to 2 mild episodes/week, with 20-30% experiencing episodes severe enough to require external help in any given year.6 A small proportion of these people, usually with impaired awareness of hypoglycemia, contribute to more than half of the incidence of SH, having recurrent disabling and sometimes life threatening events. 7CGM studies designed to study normative data suggest that while hypoglycemia is common in all insulin-treated people with diabetes, compared to subjects with type 2 diabetes (T2D), T1D subjects had twice as many hypoglycemic episodes per day, with more hours per day in the hypoglycemic range.8 However, although the incidence per patient of NSHE and SH is lower in T2D, due to the greater prevalence of T2D, the majority of episodes of SH occur in people with T2D. 9 In the US, rates of admissions for hypoglycemia have increased in recent years to 105 admissions per 100 000 person-years. 10 Antecedent hypoglycemia has been shown to blunt symptom and counter-regulatory hormonal responses to subsequent hypoglycemia.11 Over time, recurrent hypoglycemia eventually leads to a reduction in the ability to detect hypoglycemia and mount a hormonal response to it, known as impaired awareness of hypoglycemia (IAH) which can increase the risk of SH 6-fold. 12 In the T1D Exchange clinic registry, ≥ 1 SH events occurred in ~6% of over 9000 participants within 12 months, and was not associated with baseline glycated hemoglobin (HbA1c) levels. 13 Undoubtedly, SH has substantial clinical consequences on morbidity (both physical and psychological) and mortality. The more subtle effects of SH and hypoglycemia unawareness are often AbstractHypoglycemia is a major barrier toward achieving glycemic targets and is associated with significant morbidity (both psychological and physical) and mortality. This article re...

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

Cited by 151 publications

References 27 publications

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

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

Insulin Pump Therapy in Type 1 Diabetes-Merging Technology with Diabetes Care

Technology to Reduce Hypoglycemia

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