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Editorial comment by Sarah Cvach: Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial
Continuous Glucose Monitoring (CGM) has reached a certain level of use in the diabetes population. People with diabetes frequently use fingerstick capillary measurements to guide their dosing decisions. CGM systems provide glucose data in real time and detect hyper- and hypoglycaemic events and allow receiving trend information, which would not be known with ...
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Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial
Kropff J, Choudhary P, Neupane S, Barnard K, Bain SC, Kapitza C, Forst T, Link M, Dehennis A, DeVries JHDiabetes Care 2017 Jan; 40(1): 63-68
Editorial comment by Sarah Cvach
Continuous Glucose Monitoring (CGM) has reached a certain level of use in the diabetes population. People with diabetes frequently use fingerstick capillary measurements to guide their dosing decisions. CGM systems provide glucose data in real time and detect hyper- and hypoglycaemic events and allow receiving trend information, which would not be known with fingerstick measurements alone. People with diabetes get temporal information from some systems which are able to alarm for hypo- or hyperglycaemic events. CGM systems on the one hand reduce the need for fingerstick testing and effectively lower mean glucose, but on the other hand the wear time of current transcutaneous CGM is low in some populations. Implantable CGM systems may provide additional ease of use over transcutaneous CGM.
The current study used Eversense, an implantable CGM sensor in 71 participants with type 1 and 2 diabetes in a 180-day multinational, multicentre, pivotal trial. CGM accuracy was assessed with the mean absolute relative difference (MARD) for venous reference glucose values >4.2mmol/L (75mg/dL) as the primary endpoint. Secondary endpoints included alarm performance and Clark Error Grid Analysis. The primary safety outcome was device-related serious adverse events.
The primary efficacy outcome over the study duration showed a MARD for reference samples >4.2mmol/L (75mg/dL) of 11.1%. Eighty-one percent of hypoglycaemic events were detected by the CGM system within 30 minutes. No device-related serious adverse events occurred during the study. Clarke Error Grid Analysis showed 99.2% of samples in the clinically acceptable error zones A and B.
A quality of life questionnaire indicated a high device acceptance: “Using the system helped minimize the burden of diabetes in my life” got a 90% rating of 5 or higher on the scoring range from 1–7.
Sensor survival at day 90 was estimated to be 82%. Median sensor lifetime is 149 days.
The results seem to indicate the safety and accuracy of this new type of implantable CGM system and support it as an alternative for current transcutaneous CGM.
Efficacy and Safety of Mini-dose Glucagon for Treatment of Non-severe Hypoglycemia in Adults with Type 1 Diabetes
Haymond MW, DuBose SN, Rickels MR, Wolpert H, et al.J Clin Endocrinol Metab. 2017 Jun 7. doi: 10.1210/jc.2017-00591
The Risk of Severe Hypoglycemia in Type 1 Diabetes Over 30 Years of Follow-up in the DCCT/EDIC Study
Gubitosi-Klug RA, Braffett BH, White NH, Sherwin RS, et al.Diabetes Care. 2017 May 26. pii: dc162723. doi: 10.2337/dc16-2723
Review of basal-plus insulin regimen options for simpler insulin intensification in people with Type 2 diabetes mellitus
Raccah D, Huet D, Dib A, Joseph F, et al.Diabet Med. 2017 Jun 2. doi: 10.1111/dme.13390
Sustained efficacy of insulin pump therapy compared with multiple daily injections in type 2 diabetes: 12-month data from the OpT2mise randomized trial
Aronson R, Reznik Y, Conget I, Castañeda JA, Runzis S, Lee SW, Cohen O; OpT2mise Study GroupDiabetes Obes Metab. 2016 May;18(5):500-7
Editorial comment by Sarah Cvach
Since the DCCT trial it has been proven that sustained glycaemic control could be achieved with the use of CSII in Type 1 diabetes even better than with MDI. Diabetes complications are delayed or prevented using intensified therapy regimen. The Switch Study proofed the superiority of CSII versus MDI with significant reduction of HbA1c for adults and children. On the other hand it was unclear if the use of CSII in Type 2 diabetes would show better results than with MDI especially with overweight patients. Often they have a poor insulin sensitivity and do not reach their glycaemic goals. The OpT2mise study - published in several articles - has tried CSII regimen in patients with BMI >33, defined Insulin resistance and not reaching their goals with intensified injection therapy compared with MDI. The study proofed in a cross over design the superiority of CSII versus MDI. The results showed a reduction in HbA1c by 1.1 % in the CSII group and 0.4 % in the MDI group after 6 months which was significant. Insulin dose was 20.4 % lower with pump therapy than with MDI, no difference in weight gain was seen in both groups, no event of Ketoacidosis and no difference in severe hypoglycaemia. The HbA1c reduction of the pump group was maintained over 12 months and therefore showed a sustained and durable effect of insulin pump therapy in overweight Type 2 diabetes patients with defined insulin resistance not achieving their targets. It could be concluded that CSII was a good alternative in Type 2 diabetes especially for patients with high BMI, showing signs of insulin resistance, because CSII regimen leads to a 20.4 % reduction of the daily insulin dose and might therefore not enhance the body weight significantly.