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Danne T.,Bult Diabetes Center for Children and Adolescents | Forst T.,IKFE Institute for Clinical Research and Development | Deinhard J.,Accovion GmbH | Rose L.,Diabetologische Schwerpunktpraxis | And 2 more authors.
Journal of Diabetes Science and Technology | Year: 2012

Background: Injection compliance is a major problem in patients with type 1 diabetes. Increased compliance with mealtime insulin injections significantly improves metabolic control. Using an insulin pen with memory function might facilitate corrective dosing to avoid postprandial blood glucose peaks and therefore might improve overall glycemic control. Methods: This randomized, open-label, 24-week multicenter study evaluated if patients with inadequately controlled type 1 diabetes [hemoglobin A1c (HbA1c) ≥ 8%] who were randomized to use the HumaPen® Memoir™, an insulin pen device with memory function, for their mealtime insulin injections achieved superior glycemic control (HbA1c change from baseline) than patients who used the conventional device HumaPen Luxura™. Hemoglobin A1c, hypoglycemia, and pen acceptance were assessed at baseline and after 12 and 24 weeks. Results: Of 263 patients randomized, 257 were eligible for analysis: HumaPen Memoir 129, HumaPen Luxura 128; mean [standard deviation (SD)] baseline HbA1c 9.09% (0.99%); mean (SD) age 39.8 (16.5) years; 87.9% ≥18 years old; and mean (SD) diabetes duration 16.0 (11.2) years. Least square mean (95% confidence interval) changes of HbA1c up to week 24 were not significantly different between the HumaPen Memoir [0.43% (-0.59%,-0.28%)] and the HumaPen Luxura group [0.48% (0.64%, 0.32%); p = . 669]. The overall incidence of hypoglycemic episodes did not differ significantly between groups (p = . 982). Average satisfaction with insulin delivery was high in both groups. Conclusions: In this patient sample, usage of a memory function pen was not associated with superior glycemic control, suggesting that adherence to mealtime injection schedules was not improved in a relevant manner. The memory function might be helpful for specific patient populations only, e.g., children or forgetful patients. © Diabetes Technology Society. Source


Kordonouri O.,Bult Diabetes Center for Children and Adolescents | Pankowska E.,Medical University of Warsaw | Rami B.,Medical University of Vienna | Kapellen T.,Universitatsklinik Und Poliklinik For Kinder Und Jugendliche | And 6 more authors.
Diabetologia | Year: 2010

Aims/hypothesis: The value of managing children with type 1 diabetes using a combination of insulin pump and continuous glucose monitoring starting from diagnosis for improving subsequent glycaemic control and preserving residual beta cell function was determined. Methods: A total of 160 children (aged 1-16 years, mean ± SD: 8.7 ± 4.4 years; 47.5% girls) were randomised to receive insulin pump treatment with continuous glucose monitoring or conventional self-monitoring blood glucose measurements. The primary outcome was the level of HbA1c after 12 months. Other analyses included fasting C-peptide, glycaemic variability, sensor usage, adverse events, children's health-related quality of life and parent's wellbeing. Results: HbA1c was not significantly different between the two groups, but patients with regular sensor use had lower values (mean 7.1%, 95% CI 6.8-7.4%) compared with the combined group with no or low sensor usage (mean 7.6%, 95% CI 7.3-7.9%; p = 0.032). At 12 months, glycaemic variability was lower in the sensor group (mean amplitude of glycaemic excursions 80.2 ± 26.2 vs 92.0 ± 33.7; p = 0.037). Higher C-peptide concentrations were seen in sensor-treated 12- to 16-year-old patients (0.25 ± 0.12 nmol/l) compared with those treated with insulin pump alone (0.19 ± 0.07 nmol/l; p = 0.033). Severe hypoglycaemia was reported only in the group without sensors (four episodes). Conclusion/interpretation: Sensor-augmented pump therapy starting from the diagnosis of type 1 diabetes can be associated with less decline in fasting C-peptide particularly in older children, although regular sensor use is a prerequisite for improved glycaemic control. Trial registration: ISRCTN.org ISRCTN05450731 Funding: Medtronic International Trading Sàrl, Tolochenaz, Switzerland © 2010 Springer-Verlag. Source


Kordonouri O.,Bult Diabetes Center for Children and Adolescents | Hartmann R.,Bult Diabetes Center for Children and Adolescents | Danne T.,Bult Diabetes Center for Children and Adolescents
Diabetes Research and Clinical Practice | Year: 2011

In the last decades, we are experiencing an increasing use of insulin pumps for the treatment of type 1 diabetes in children and adolescents. The most frequent reasons for switching from insulin injection schemes to pump therapy are frequent and/or severe hypogly-caemia, dawn phenomenon, poor glycaemic control, wish for more flexibility in daily life, and needle phobia. In toddlers and preschoolers, pumps are frequently introduced from the onset of type 1 diabetes. Pumps offer the possibility of adjustingbasal insulin rates individually on an age-depended manner as well as of optimizing meal-related insulin requirements according to the meal composition by using three different kinds of boluses. Structured and intensive education of patients and their families on basics and specific requirements of insulin pump therapy is essential in order to get them familiar with the devices and their features. There is increasing evidence both from multicentre cross-sectional studies as well as from meta-analyses of randomized clinical trials in paediatric populations showing that patients with pump therapy can achieve a more favourable metabolic control accompanied with less hypoglycaemic events than those with multiple daily injections. © 2011 Elsevier Ireland Ltd. Source

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