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Publications (7)14.31 Total impact

  • Lutz Heinemann · Lars Krinelke ·
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    ABSTRACT: Continuous subcutaneous insulin infusion from an insulin pump depends on reliable transfer of the pumped insulin to the subcutaneous insulin depot by means of an insulin infusion set (IIS). Despite their widespread use, the published knowledge about IISs and related issues regarding the impact of placement and wear time on insulin absorption/insulin action is relatively small. We also have to acknowledge that our knowledge is limited with regard to how often patients encounter issues with IISs. Reading pump wearer blogs, for instance, suggests that these are a frequent source of trouble. There are no prospective clinical studies available on current IIS and insulin formulations that provide representative data on the type and frequency of issues with infusion sets. The introduction of new IISs and patch pumps may foster a reassessment of available products and of patient problems related to their use. The aim of this review is to summarize the current knowledge and recommendations about IISs and to highlight potential directions of IIS development in order to make insulin absorption safer and more efficient.
    Journal of diabetes science and technology 07/2012; 6(4):954-64. DOI:10.1177/193229681200600429
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    ABSTRACT: Fast-acting insulin analogs have been available since 1996. The absorption rate of these insulins is still too slow to mimic the physiological insulin action in healthy subjects. This study investigates the clinical performance of InsuPatch™, a local skin-heating device, on postprandial glucose excursion. Twenty-four type 1 diabetes mellitus subjects on continuous subcutaneous insulin infusion were included in this crossover study [10 male, 14 female, age: 43.5 ± 11.3 years, diabetes duration: 18.3 ± 10.5 years, glycosylated hemoglobin: 7.4 ± 0.8%, body mass index: 25.0 ± 3.0 kg/m(2) (mean ± standard deviation)]. The impact of local skin heating was measured by dividing the two-hour area under the curve by integration time (AUC/t(120)) for blood glucose (BG) above baseline after two standardized breakfast and dinner meal pairs (with and without heating) per subject. For the first breakfast pair, venous insulin concentration was also measured. A significant reduction was found for the AUC/t(120) after breakfast and after dinner meals (42 breakfast meal pairs, AUC/t(120) not heated 66.4 ± 32.8 mg/dl vs heated 56.8 ± 34.0 mg/dl, p = .017; 38 dinner meal pairs, AUC/t(120) not heated 30.8 ± 31.0 mg/dl vs heated 18.4 ± 23.9 mg/dl, p = .0028). The maximum venous insulin concentration with heating was 27% higher than without heating (n = 23). The number of hypoglycemic events on days with heating (n = 9) was similar to the number of days without heating (n = 13). Local heating of the skin around the infusion site significantly reduced postprandial BG by enhancing insulin absorption. The heating device was well tolerated, and it could facilitate development of closed-loop systems.
    Journal of diabetes science and technology 03/2012; 6(2):320-7. DOI:10.1177/193229681200600215
  • E Zschornack · A Westhoff · S Pleus · C Haug · LG Krinelke · G Freckmann ·

    Diabetologie und Stoffwechsel; 05/2011
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    ABSTRACT: OBJECTIVE Evaluation of the time required until a change in the basal insulin infusion rate with an insulin pump induces subsequent changes in the metabolic effect. RESEARCH DESIGN AND METHODS In this euglycemic glucose clamp study, 10 male subjects with type 1 diabetes received three different subcutaneous insulin infusion rates (0.5, 1.0, and 2.0 units/h; for 4 h each) of insulin lispro (IL) with insulin pumps. RESULTS An increase in insulinemia occurred within 15-30 min after changing the infusion rate. While the serum IL levels reached a steady state at the end of the infusion period, the glucose infusion rates did not always reach steady-state levels with the higher infusion rates. However, an increase in the glucose consumption occurred within 30-60 min after switching the infusion rate. CONCLUSIONS Several hours are required until a new steady state in the metabolic effect is achieved after a significant change in basal insulin infusion.
    Diabetes care 07/2009; 32(8):1437-9. DOI:10.2337/dc09-0595 · 8.42 Impact Factor
  • L Heinemann · L Nosek · C Kapitza · MA Schweitzer · P Stephan · S Grunder · L Krinelke ·

    Diabetologie und Stoffwechsel 04/2009; 4(S 01). DOI:10.1055/s-0029-1222026 · 0.33 Impact Factor
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    ABSTRACT: The goal of the study was to determine whether continuous subcutaneous insulin infusion (CSII) differs from a multiple daily injection (MDI) regimen based on neutral protamine hagedorn (NPH) as basal insulin with respect to glycaemic control and quality of life in people with Type 1 diabetes. The 5-Nations trial was a randomized, controlled, crossover trial conducted in 11 European centres. Two hundred and seventy-two patients were treated with CSII or MDI during a 2-month run-in period followed by a 6-month treatment period, respectively. The quality of glycaemic control was assessed by HbA(1c), blood glucose values, and the frequency of hypoglycaemic events. For the evaluation of the quality of life, three different self-report questionnaires have been assessed. CSII treatment resulted in lower HbA(1c) (7.45 vs. 7.67%, P < 0.001), mean blood glucose level (8.6 vs. 9.4 mmol/l, P < 0.001) and less fluctuation in blood glucose levels than MDI (+/- 3.9 vs. +/- 4.3 mmol/l, P < 0.001). There was a marked reduction in the frequency of hypoglycaemic events using CSII compared with MDI, with an incidence ratio of 1.12 [95% confidence interval (CI): 1.08-1.17] and 2.61 (95% CI: 1.59-4.29) for mild and severe hypoglycaemia, respectively. The overall score of the diabetes quality of life questionnaire was higher for CSII (P < 0.001), and an improvement in pump users' perception of mental health was detected when using the SF-12 questionnaire (P < 0.05). CSII usage offers significant benefits over NPH-based MDI for individuals with Type 1 diabetes, with improvement in all significant metabolic parameters as well as in patients' quality of life. Additional studies are needed to compare CSII with glargine- and detemir-based MDI.
    Diabetic Medicine 02/2006; 23(2):141-7. DOI:10.1111/j.1464-5491.2005.01738.x · 3.12 Impact Factor
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    ABSTRACT: A viscometric affinity sensor has been developed to measure the interstitial glucose concentration continuously. In a pilot clinical study its performance was assessed under conditions close to everyday life. Additionally, different insertion sites were tested for their suitability to apply subcutaneous glucose sensors. Twelve subjects, 10 of whom with type 1 diabetes, were examined for 8 h. Sensors were applied subcutaneously at the forearm and the abdomen of each subject. Capillary blood glucose references were obtained from the finger tip every 30 min. Retrospective calibration was carried out individually with Deming regression. After retrospective calibration the 95% limits of agreement in the plot of the differences between sensor signals and references versus their means were +/-60 mg/dL. The sensitivity of the sensors remained stable over the entire measuring period, without any significant differences between the sensors at forearm and abdomen. Correcting for the observed time delay of 15 min between references and sensor values the limits of agreements were reduced to +/-38 mg/dL. Furthermore, error grid analysis showed 89.3% of the paired values in zone A and 9.6% in zone B. Only 1.1% were clinically unacceptable (zone D). The performance of the viscometric affinity sensor shows the potential of the measuring principle under in vivo conditions. Forearm and abdomen seem to be similarly well suited for the application of subcutaneous sensors. The signal stability over time and the absence of enzymatic, chemical, or electrode reactions are advantages of the viscometric affinity principle.
    Diabetes Technology &amp Therapeutics 01/2005; 6(6):790-9. DOI:10.1089/dia.2004.6.790 · 2.11 Impact Factor