Effectiveness of Sensor-Augmented Insulin-Pump Therapy in Type 1 Diabetes

Bergenstal, Richard M.; Tamborlane, William V.; Ahmann, Andrew J.; Buse, John B.; Dailey, George; Davis, Stephen N.; Joyce, Carol; Peoples, Tim; Perkins, Bruce A.; Welsh, John; Willi, Steven M.; Wood, Mark

doi:10.1056/nejmoa1002853

Cited by 819 publications

(647 citation statements)

References 11 publications

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“…A recent meta-analysis confirms these results [27] and a Cochrane review appeared a short while ago [28]. The improvement is observed at 3 months [23] and maintained at 6 months [24], 12 months [26,29,30] and 18 months [24], the maximum follow-up of the studies to date. The improvement is observed whatever the initial level of HbA 1c is, whether the patient uses a pump or multiple daily injections [21] and however long a pump has previously been used by a particular patient.…”

Section: Description Of the Technologymentioning

confidence: 75%

“…The information provided by CGM is constantly accessible and permits the patient to adjust daily insulin dosing, avoid unnoticed high or low glucose levels and thus improve his glucose control. In the studies, CGM significantly reduces HbA 1c by about 0.5% as compared to intermittent SMBG, provided that the patient uses CGM at least 40% of the prescribed time [19,[23][24][25][26]. The results of these studies are detailed in Table 2.…”

Section: Description Of the Technologymentioning

confidence: 99%

“…To date, no study has had as its principal objective the reduction of severe hypoglycaemias. Severe repeated hypoglycaemia [26] or hypoglycaemia unawareness [19] has even been among the exclusion criteria in certain studies. A study having as its principal objective the reduction of mild hypoglycaemias [35] demonstrates that the use of a CGM device for six months by patients with well-controlled type 1 diabetes (HbA 1c < 7.5%) treated by pump (the majority) or multiple injections makes possible a reduction by half of the time spent in hypoglycaemia (P = 0.03) and a supplementary improvement of HbA 1c (-0.27%, P = 0.0008) [35].…”

Section: Hypoglycaemia and Glucose Variabilitymentioning

confidence: 99%

“…The success of CGM depends not only on the selection of patients capable of using it at least 40% of the time [19,[23][24][25][26] and of applying the data but equally on the development of a specific educational program administered by an experienced team [19].…”

Section: Continuous Glucosemonitoring: Good Clinical Practice Recommementioning

confidence: 99%

See 3 more Smart Citations

Real-time continuous glucose monitoring (CGM) integrated into the treatment of type 1 diabetes: Consensus of experts from SFD, EVADIAC and SFE

Benhamou

Catargi

Delenne³

et al. 2012

Diabetes & Metabolism

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Section: Description Of the Technologymentioning

confidence: 75%

Section: Description Of the Technologymentioning

confidence: 99%

Section: Hypoglycaemia and Glucose Variabilitymentioning

confidence: 99%

Section: Continuous Glucosemonitoring: Good Clinical Practice Recommementioning

confidence: 99%

See 2 more Smart Citations

Real-time continuous glucose monitoring (CGM) integrated into the treatment of type 1 diabetes: Consensus of experts from SFD, EVADIAC and SFE

Benhamou

Catargi

Delenne³

et al. 2012

Diabetes & Metabolism

View full text Add to dashboard Cite

“…A recent meta-analysis done of 15 randomized trials of CSII versus multiple daily injections found no significant difference in severe or nocturnal hypoglycemia between the two therapies [21]. In a newly published multicenter randomized controlled trial of glucose sensoraugmented CSII therapy versus a regimen of multiple daily insulin injections, CSII produced a significantly lower glycated hemoglobin level at 1 year, with no significant difference in the rate of severe hypoglycemia between the two groups [22]. The Food and Drug Administration has studied medical device adverse event reports for insulin pumps in adolescents over a 10-year period, revealing 13 deaths.…”

Section: What Are the Advantages And Risks Of Insulin Pump Therapy?mentioning

confidence: 99%

Case Files of the Harvard Medical Toxicology Fellowship at Children’s Hospital Boston: An Insulin Overdose

Skolnik

Ewald

2010

J. Med. Toxicol.

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A 16-year-old boy with a history of type I diabetes mellitus being managed with an insulin pump presented to the emergency department in cardiac arrest. Per report from the patient's mother, the patient had noticed that his insulin cartridge, containing insulin lispro, was empty the night prior to admission so he had replaced it at approximately 7:00 PM. He had used his glucometer through the night with recorded values of 225-389 mg/dL and had administered a total of 14.5 units of insulin via his pump. At around 6:30 AM, the morning of admission, his mother attempted to wake him for school and found him cyanotic and motionless. She attempted to obtain a fingerstick glucose measurement but was unable to do so and administered glucagon, as well as activating Emergency Medical Services (EMS). When EMS arrived, the patient was pulseless. Cardiopulmonary resuscitation was initiated, and the patient was endotracheally intubated. Point-of-care glucose determination was 81 mg/dL. He received epinephrine, atropine, naloxone, and an ampule of 50% dextrose (25 g) during his prehospital care. He was defibrillated twice at 200 J for ventricular fibrillation. He was transferred to the emergency department with cardiopulmonary resuscitation in progress. EMS reported that an empty insulin syringe had been seen underneath the patient's bed. After approximately 1 h of resuscitative efforts, during which the patient received additional epinephrine, sodium bicarbonate, and hydrocortisone, he had return of spontaneous circulation. His initial arterial blood gas revealed a pH of 6.8, PaCO 2 of 70 mmHg, and PaO 2 of 335 mmHg. His serum glucose at that time was 377 mg/dL, and the anion gap was 39 mEq/L with urine negative for ketones. He underwent computed tomography scan of the head, chest, abdomen, and pelvis that demonstrated left upper lobe consolidation and gastric distention but was otherwise normal. He was transferred to a tertiary-care children's hospital where his serum glucose on arrival was 50 mg/dL. He received 25 g of intravenous dextrose, and an infusion of 10% dextrose in normal saline was started. A toxicology consult was obtained.

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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

400

290

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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.

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Effectiveness of Sensor-Augmented Insulin-Pump Therapy in Type 1 Diabetes

Cited by 819 publications

References 11 publications

Real-time continuous glucose monitoring (CGM) integrated into the treatment of type 1 diabetes: Consensus of experts from SFD, EVADIAC and SFE

Real-time continuous glucose monitoring (CGM) integrated into the treatment of type 1 diabetes: Consensus of experts from SFD, EVADIAC and SFE

Case Files of the Harvard Medical Toxicology Fellowship at Children’s Hospital Boston: An Insulin Overdose

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

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