Objectives: In diabetic nephropathy the decline of renal function causes modifications of the insulin and carbohydrate metabolism resulting in changed insulin requirements. The aim of the present study was to identify potential differences in the requirements of human insulin and various insulin analogues in patients with type 1 diabetes mellitus and renal dysfunction. Methods: The insulin requirements of 346 patients with type 1 diabetes mellitus under everyday life circumstances were assessed in an observational study. Simultaneously, laboratory parameters were measured and the estimated glomerular filtration rate (eGFR) was calculated using the formula by Cockcroft-Gault. Medical history and concomitant medication were recorded. The insulin requirements of long-and short-acting insulin were tested for a relationship with the eGFR and laboratory parameters. Results: The dosage of long-acting human insulin did not show any relation to eGFR. In contrast, a strong positive relation between dosage and renal function was found for insulin glargine and insulin detemir. After classification according to renal function, the insulin dosage at eGFR less than 60 ml/min was 29.7% lower in glargine-treated and 27.3% lower in detemir-treated patients compared with eGFR greater than 90 ml/min. Considering the whole range of eGFR, short-acting human insulin did not show a relation with renal function. Only after classification according to renal function was a dose reduction found for human insulin at eGFR less than 60 ml/min. In contrast, requirements of insulin lispro were significantly related to eGFR over the whole range of eGFR. At eGFR less than 60 ml/min the insulin dosage was 32.6% lower than at eGFR greater than 90 ml/min. The requirements of insulin aspart did not show any association with the eGFR. Conclusions: Patients with type 1 diabetes mellitus show different insulin requirements according to the renal function depending on the applied insulin. This finding is essential for the adjustment of insulin therapy in patients with diabetic nephropathy to achieve balanced glycemic control. To determine the underlying mechanisms, further studies on the pharmacokinetics and pharmacodynamics of the different insulins in patients with diabetic nephropathy are needed.
Glucose monitoring systems (GMS) are routinely used by patients with diabetes to monitor glycemic control and modify treatment as needed. In this respect, the analytical performance of GMS is of course of crucial importance. The accuracy of GMS is usually assessed according to the Guidelines of the International Organization for Standardization (ISO). A new standard has recently been published with more stringent criteria than in the previous edition.1,2 Minimum acceptable system accuracy requirements for GMS now specify that ≥95% of the glucose meter results may not differ more than ±15 mg/dl from the reference method at glucose concentrations < 100 mg/dl (previously < 75 mg/dl) and ±15% (previously ±20%) at glucose concentrations ≥ 100 mg/dl.1 Furthermore, concerning prevalence and range of outliers, it is now specified that >99% of measured glucose values must fall in zones A and B of the consensus error grid.During the consultation process of the new criteria it has been suggested that the analytical performance of GMS is highly dependent on its intended use.3-6 For example, insulin-dependent patients under intensified glycemic control require highly accurate devices for adequate insulin dosing, whereas patients with Type 2 diabetes who are treated with medication with no or little risk of hypoglycemia could use less accurate GMS. It has, therefore, been suggested that the analytical accuracy of GMS should be tested not only in relation to BG level ranges below and above 100 mg/dL but also in relation to different glycemic ranges, as already previously proposed for continuous glucose monitoring systems. The aim of the present study was to analyze test results from 27 GMS obtained in a clinical setting, with regard to (1) analytical accuracy according to the new ISO accuracy limits as well as after stratification into 5 different BG level ranges and (2) frequency and extent of outliers.
AbstractWe investigated the analytical accuracy of 27 glucose monitoring systems (GMS) in a clinical setting, using the new ISO accuracy limits. In addition to measuring accuracy at blood glucose (BG) levels < 100 mg/dl and > 100 mg/dl, we also analyzed devices performance with respect to these criteria at 5 specific BG level ranges, making it possible to further differentiate between devices with regard to overall performance. Carbohydrate meals and insulin injections were used to induce an increase or decrease in BG levels in 37 insulin-dependent patients. Capillary blood samples were collected at 10-minute intervals, and BG levels determined simultaneously using GMS and a laboratory-based method. Results obtained via both methods were analyzed according to the new ISO criteria. Only 12 of 27 devices tested met overall requirements of the new ISO accuracy limits. When accuracy was assessed at BG levels < 100 mg/dl and > 100 mg/dl, criteria were met by 14 and 13 devices, respectively. A more detailed analysis involving 5 different BG level ranges revealed that 13 (48.1%) devices met the required criteria at BG levels between...
he present study demonstrates good tolerability and measurement performance of the biosensor. The reasons for an increase in the lag time are still unknown; local reactions may be involved.
In clinical practice, age and renal function must be taken into consideration when interpreting 1,5-AG levels, even in the absence of advanced renal impairment.
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