Journal of diabetes science and technology, Jan 17, 2015
Hemoglobin A1c (HbA1c) measurement has come to be a cornerstone in modern diabetes therapy. Howev... more Hemoglobin A1c (HbA1c) measurement has come to be a cornerstone in modern diabetes therapy. However, the methodological aspects of this type of measurement have been given little attention lately due to its position as an established method of choice. Nevertheless, quite a number of issues face practical application, such as clinically relevant differences between different measurement methods-both lab-based and point-of-care (POCT) systems will show better or worse diabetes management results after switching methods; and there are a number of possible reasons that need to be known and observed in practice. The aim of this review is to draw attention to these problems from a German point of view and provide suggestions for appropriate measures to improve the situation.
For self-monitoring of blood glucose by people with diabetes, the reliability of the measured blo... more For self-monitoring of blood glucose by people with diabetes, the reliability of the measured blood glucose values is a prerequisite in order to ensure correct therapeutic decisions. Requirements for system accuracy are defined by the International Organization for Standardization (ISO) in the standard EN ISO 15197:2003. However, even a system with high analytical quality is not a guarantee for accurate and reliable measurement results. Under routine life conditions, blood glucose measurement results are affected by several factors. First, the act of performing measurements as well as the handling of the system may entail numerous possible error sources, such as traces of glucose-containing products on the fingertips, the use of deteriorated test strips, or the incorrect storage of test strips. Second, ambient and sampling conditions such as high altitude, partial pressure of oxygen, ambient temperature, and the use of alternate test sites can have an influence on measurement result...
Neben der technischen Genauigkeit der Insulinpumpen spielt auch die Genauigkeit anderer Faktoren,... more Neben der technischen Genauigkeit der Insulinpumpen spielt auch die Genauigkeit anderer Faktoren, z. B. der Kohlenhydratschätzung, eine wichtige Rolle.
Worldwide the quality of care of patients with type 2 diabetes has been investigated only by anal... more Worldwide the quality of care of patients with type 2 diabetes has been investigated only by analysing within cross-sectional studies. But the quality of care in relation to statutory or private health plans in not known. It was the aim of this study to ascertain retrospectively, how in the course of time from first diagnosis the quality of medical care of patients with type 2 diabetes differed depending on the type of health insurance of the individual patient. As part of the ROSSO study (a German retrospective epidemiological cohort study), data on all patients diagnosed with type 2 diabetes between 1.1.1995 and 31.12.1999 had been recorded. They had been collected from 192 randomly selected general practitioner or internal medicine specialist practices. The data of 3268 patients diagnosed with type 2 diabetes were recorded. The mean observation period was 6.5 years. The mean age of this patients at the time of diagnosis of diabetes was 62.4 +/- 9.6 years, 49 % being male. The por...
Journal of diabetes science and technology, Jan 17, 2015
Diabetes technology is a cornerstone of diabetes management in the 21st century, with advances in... more Diabetes technology is a cornerstone of diabetes management in the 21st century, with advances in available devices over recent years playing a central role in the way that health care has progressed. Psychosocial interventions have been shown to have a positive impact on glycemic control, reduce psychological distress and reduce costs of health care. Addressing and improving psychosocial outcomes that complement biomedical improvements and looking to the future are crucial to enhance patient acceptance of artificial pancreas (AP) systems. To achieve closer collaboration and comparability across different AP research trials, a working group was established. Existing measures fail to adequately capture the extent to which human and psychological factors play a role in the uptake and efficient use of AP systems. Understanding these factors will ultimately lead to the most benefit for users. Reliable measures of the psychosocial impact of AP systems for users is crucial to ensure that ...
Journal of diabetes science and technology, Jan 14, 2015
In the European Union (EU), the ISO (International Organization for Standardization) 15197 standa... more In the European Union (EU), the ISO (International Organization for Standardization) 15197 standard is applicable for the evaluation of systems for self-monitoring of blood glucose (SMBG) before the market approval. In 2013, a revised version of this standard was published. Relevant revisions in the analytical performance requirements are the inclusion of the evaluation of influence quantities, for example, hematocrit, and some changes in the testing procedures for measurement precision and system accuracy evaluation, for example, number of test strip lots. Regarding system accuracy evaluation, the most important change is the inclusion of more stringent accuracy criteria. In 2014, the Food and Drug Administration (FDA) in the United States published their own guidance document for the premarket evaluation of SMBG systems with even more stringent system accuracy criteria than stipulated by ISO 15197:2013. The establishment of strict accuracy criteria applicable for the premarket eva...
Journal of diabetes science and technology, Jan 7, 2015
There are no widely accepted parameters to assess the quality of glucose clamps. Thus, we selecte... more There are no widely accepted parameters to assess the quality of glucose clamps. Thus, we selected different parameters describing clamp quality. These parameters were then evaluated in glucose clamps carried out with ClampArt, a novel CE-marked, state-of-the-art fully automated glucose clamp device employing continuous blood glucose (BG) measurements and minute-by-minute adaptations of glucose infusion rate (GIR). Thirty-nine glucose clamps were performed in 10 healthy and 29 subjects with type 1 diabetes (T1DM) (total duration 583 h). ClampArt-based BG measurements were compared with those obtained with a laboratory reference method. Clamp quality was assessed by 5 parameters: (1) difference (mg/dl) of all paired BG measurements of ClampArt versus reference method ("trueness"), (2) coefficient of variation (CV, %) of ClampArt's BG measurements at target clamp level ("precision"), (3) mean absolute relative difference (MARD, %) at target clamp level ("a...
Worldwide the quality of care of patients with type 2 diabetes has been investigated only by anal... more Worldwide the quality of care of patients with type 2 diabetes has been investigated only by analysing within cross-sectional studies. But the quality of care in relation to statutory or private health plans in not known. It was the aim of this study to ascertain retrospectively, how in the course of time from first diagnosis the quality of medical care of patients with type 2 diabetes differed depending on the type of health insurance of the individual patient. As part of the ROSSO study (a German retrospective epidemiological cohort study), data on all patients diagnosed with type 2 diabetes between 1.1.1995 and 31.12.1999 had been recorded. They had been collected from 192 randomly selected general practitioner or internal medicine specialist practices. The data of 3268 patients diagnosed with type 2 diabetes were recorded. The mean observation period was 6.5 years. The mean age of this patients at the time of diagnosis of diabetes was 62.4 +/- 9.6 years, 49 % being male. The por...
In patients with diabetic nephropathy, near-normalization of blood pressure (BP) and blood sugar ... more In patients with diabetic nephropathy, near-normalization of blood pressure (BP) and blood sugar may have a beneficial impact on changes in kidney function, but visually impaired patients may face difficulties when striving for optimal control of hypertension and hyperglycemia. In a prospective feasibility study, we followed a group of nine blind Type I (insulin-dependent) diabetic patients (mean age 30 +/- 4 years) with overt diabetic nephropathy and uncontrolled hypertension. All patients received intensified insulin therapy after a structured diabetes treatment and teaching program, and adapted their antihypertensive drug treatment to self-monitored BP values. At recruitment, HbA1c values were 5.8 +/- 0.6%, and remained stable at 6.3 +/- 1.7% after a mean observation period of 27 months. BP pressure decreased from 150 +/- 14/99 +/- 14 mmHg to 130 +/- 17/86 +/- 10 mmHg after 1 year, and to 140 +/- 14/92 +/- 9 mmHg at the last examination, (p less than 0.05). Serum creatinine and c...
To evaluate the feasibility of day and night closed-loop insulin delivery in adults with type 1 d... more To evaluate the feasibility of day and night closed-loop insulin delivery in adults with type 1 diabetes under free-living conditions. Seventeen adults with type 1 diabetes on insulin pump therapy (means ± SD age 34 ± 9 years, HbA1c 7.6 ± 0.8%, and duration of diabetes 19 ± 9 years) participated in an open-label multinational three-center crossover study. In a random order, participants underwent two 8-day periods (first day at the clinical research facility followed by 7 days at home) of sensor-augmented insulin pump therapy (SAP) or automated closed-loop insulin delivery. The primary end point was the time when sensor glucose was in target range between 3.9 and 10.0 mmol/L during the 7-day home phase. During the home phase, the percentage of time when glucose was in target range was significantly higher during closed-loop compared with SAP (median 75% [interquartile range 61-79] vs. 62% [53-70], P = 0.005). Mean glucose (8.1 vs. 8.8 mmol/L, P = 0.027) and time spent above target (...
Despite therapeutic advances, many people with type 1 diabetes are still unable to achieve optima... more Despite therapeutic advances, many people with type 1 diabetes are still unable to achieve optimal glycaemic control, limited by the occurrence of hypoglycaemia. The objective of the present study is to determine the effectiveness of day and night home closed-loop over the medium term compared with sensor-augmented pump therapy in adults with type 1 diabetes and suboptimal glycaemic control. The study will adopt an open label, three-centre, multinational, randomised, two-period crossover study design comparing automated closed-loop glucose control with sensor augmented insulin pump therapy. The study will aim for 30 completed participants. Eligible participants will be adults (≥18 years) with type 1 diabetes treated with insulin pump therapy and suboptimal glycaemic control (glycated haemoglobin (HbA1c)≥7.5% (58 mmol/mmol) and ≤10% (86 mmol/mmol)). Following a 4-week optimisation period, participants will undergo a 3-month use of automated closed-loop insulin delivery and sensor-aug...
Journal of diabetes science and technology, Jan 17, 2015
Hemoglobin A1c (HbA1c) measurement has come to be a cornerstone in modern diabetes therapy. Howev... more Hemoglobin A1c (HbA1c) measurement has come to be a cornerstone in modern diabetes therapy. However, the methodological aspects of this type of measurement have been given little attention lately due to its position as an established method of choice. Nevertheless, quite a number of issues face practical application, such as clinically relevant differences between different measurement methods-both lab-based and point-of-care (POCT) systems will show better or worse diabetes management results after switching methods; and there are a number of possible reasons that need to be known and observed in practice. The aim of this review is to draw attention to these problems from a German point of view and provide suggestions for appropriate measures to improve the situation.
For self-monitoring of blood glucose by people with diabetes, the reliability of the measured blo... more For self-monitoring of blood glucose by people with diabetes, the reliability of the measured blood glucose values is a prerequisite in order to ensure correct therapeutic decisions. Requirements for system accuracy are defined by the International Organization for Standardization (ISO) in the standard EN ISO 15197:2003. However, even a system with high analytical quality is not a guarantee for accurate and reliable measurement results. Under routine life conditions, blood glucose measurement results are affected by several factors. First, the act of performing measurements as well as the handling of the system may entail numerous possible error sources, such as traces of glucose-containing products on the fingertips, the use of deteriorated test strips, or the incorrect storage of test strips. Second, ambient and sampling conditions such as high altitude, partial pressure of oxygen, ambient temperature, and the use of alternate test sites can have an influence on measurement result...
Neben der technischen Genauigkeit der Insulinpumpen spielt auch die Genauigkeit anderer Faktoren,... more Neben der technischen Genauigkeit der Insulinpumpen spielt auch die Genauigkeit anderer Faktoren, z. B. der Kohlenhydratschätzung, eine wichtige Rolle.
Worldwide the quality of care of patients with type 2 diabetes has been investigated only by anal... more Worldwide the quality of care of patients with type 2 diabetes has been investigated only by analysing within cross-sectional studies. But the quality of care in relation to statutory or private health plans in not known. It was the aim of this study to ascertain retrospectively, how in the course of time from first diagnosis the quality of medical care of patients with type 2 diabetes differed depending on the type of health insurance of the individual patient. As part of the ROSSO study (a German retrospective epidemiological cohort study), data on all patients diagnosed with type 2 diabetes between 1.1.1995 and 31.12.1999 had been recorded. They had been collected from 192 randomly selected general practitioner or internal medicine specialist practices. The data of 3268 patients diagnosed with type 2 diabetes were recorded. The mean observation period was 6.5 years. The mean age of this patients at the time of diagnosis of diabetes was 62.4 +/- 9.6 years, 49 % being male. The por...
Journal of diabetes science and technology, Jan 17, 2015
Diabetes technology is a cornerstone of diabetes management in the 21st century, with advances in... more Diabetes technology is a cornerstone of diabetes management in the 21st century, with advances in available devices over recent years playing a central role in the way that health care has progressed. Psychosocial interventions have been shown to have a positive impact on glycemic control, reduce psychological distress and reduce costs of health care. Addressing and improving psychosocial outcomes that complement biomedical improvements and looking to the future are crucial to enhance patient acceptance of artificial pancreas (AP) systems. To achieve closer collaboration and comparability across different AP research trials, a working group was established. Existing measures fail to adequately capture the extent to which human and psychological factors play a role in the uptake and efficient use of AP systems. Understanding these factors will ultimately lead to the most benefit for users. Reliable measures of the psychosocial impact of AP systems for users is crucial to ensure that ...
Journal of diabetes science and technology, Jan 14, 2015
In the European Union (EU), the ISO (International Organization for Standardization) 15197 standa... more In the European Union (EU), the ISO (International Organization for Standardization) 15197 standard is applicable for the evaluation of systems for self-monitoring of blood glucose (SMBG) before the market approval. In 2013, a revised version of this standard was published. Relevant revisions in the analytical performance requirements are the inclusion of the evaluation of influence quantities, for example, hematocrit, and some changes in the testing procedures for measurement precision and system accuracy evaluation, for example, number of test strip lots. Regarding system accuracy evaluation, the most important change is the inclusion of more stringent accuracy criteria. In 2014, the Food and Drug Administration (FDA) in the United States published their own guidance document for the premarket evaluation of SMBG systems with even more stringent system accuracy criteria than stipulated by ISO 15197:2013. The establishment of strict accuracy criteria applicable for the premarket eva...
Journal of diabetes science and technology, Jan 7, 2015
There are no widely accepted parameters to assess the quality of glucose clamps. Thus, we selecte... more There are no widely accepted parameters to assess the quality of glucose clamps. Thus, we selected different parameters describing clamp quality. These parameters were then evaluated in glucose clamps carried out with ClampArt, a novel CE-marked, state-of-the-art fully automated glucose clamp device employing continuous blood glucose (BG) measurements and minute-by-minute adaptations of glucose infusion rate (GIR). Thirty-nine glucose clamps were performed in 10 healthy and 29 subjects with type 1 diabetes (T1DM) (total duration 583 h). ClampArt-based BG measurements were compared with those obtained with a laboratory reference method. Clamp quality was assessed by 5 parameters: (1) difference (mg/dl) of all paired BG measurements of ClampArt versus reference method ("trueness"), (2) coefficient of variation (CV, %) of ClampArt's BG measurements at target clamp level ("precision"), (3) mean absolute relative difference (MARD, %) at target clamp level ("a...
Worldwide the quality of care of patients with type 2 diabetes has been investigated only by anal... more Worldwide the quality of care of patients with type 2 diabetes has been investigated only by analysing within cross-sectional studies. But the quality of care in relation to statutory or private health plans in not known. It was the aim of this study to ascertain retrospectively, how in the course of time from first diagnosis the quality of medical care of patients with type 2 diabetes differed depending on the type of health insurance of the individual patient. As part of the ROSSO study (a German retrospective epidemiological cohort study), data on all patients diagnosed with type 2 diabetes between 1.1.1995 and 31.12.1999 had been recorded. They had been collected from 192 randomly selected general practitioner or internal medicine specialist practices. The data of 3268 patients diagnosed with type 2 diabetes were recorded. The mean observation period was 6.5 years. The mean age of this patients at the time of diagnosis of diabetes was 62.4 +/- 9.6 years, 49 % being male. The por...
In patients with diabetic nephropathy, near-normalization of blood pressure (BP) and blood sugar ... more In patients with diabetic nephropathy, near-normalization of blood pressure (BP) and blood sugar may have a beneficial impact on changes in kidney function, but visually impaired patients may face difficulties when striving for optimal control of hypertension and hyperglycemia. In a prospective feasibility study, we followed a group of nine blind Type I (insulin-dependent) diabetic patients (mean age 30 +/- 4 years) with overt diabetic nephropathy and uncontrolled hypertension. All patients received intensified insulin therapy after a structured diabetes treatment and teaching program, and adapted their antihypertensive drug treatment to self-monitored BP values. At recruitment, HbA1c values were 5.8 +/- 0.6%, and remained stable at 6.3 +/- 1.7% after a mean observation period of 27 months. BP pressure decreased from 150 +/- 14/99 +/- 14 mmHg to 130 +/- 17/86 +/- 10 mmHg after 1 year, and to 140 +/- 14/92 +/- 9 mmHg at the last examination, (p less than 0.05). Serum creatinine and c...
To evaluate the feasibility of day and night closed-loop insulin delivery in adults with type 1 d... more To evaluate the feasibility of day and night closed-loop insulin delivery in adults with type 1 diabetes under free-living conditions. Seventeen adults with type 1 diabetes on insulin pump therapy (means ± SD age 34 ± 9 years, HbA1c 7.6 ± 0.8%, and duration of diabetes 19 ± 9 years) participated in an open-label multinational three-center crossover study. In a random order, participants underwent two 8-day periods (first day at the clinical research facility followed by 7 days at home) of sensor-augmented insulin pump therapy (SAP) or automated closed-loop insulin delivery. The primary end point was the time when sensor glucose was in target range between 3.9 and 10.0 mmol/L during the 7-day home phase. During the home phase, the percentage of time when glucose was in target range was significantly higher during closed-loop compared with SAP (median 75% [interquartile range 61-79] vs. 62% [53-70], P = 0.005). Mean glucose (8.1 vs. 8.8 mmol/L, P = 0.027) and time spent above target (...
Despite therapeutic advances, many people with type 1 diabetes are still unable to achieve optima... more Despite therapeutic advances, many people with type 1 diabetes are still unable to achieve optimal glycaemic control, limited by the occurrence of hypoglycaemia. The objective of the present study is to determine the effectiveness of day and night home closed-loop over the medium term compared with sensor-augmented pump therapy in adults with type 1 diabetes and suboptimal glycaemic control. The study will adopt an open label, three-centre, multinational, randomised, two-period crossover study design comparing automated closed-loop glucose control with sensor augmented insulin pump therapy. The study will aim for 30 completed participants. Eligible participants will be adults (≥18 years) with type 1 diabetes treated with insulin pump therapy and suboptimal glycaemic control (glycated haemoglobin (HbA1c)≥7.5% (58 mmol/mmol) and ≤10% (86 mmol/mmol)). Following a 4-week optimisation period, participants will undergo a 3-month use of automated closed-loop insulin delivery and sensor-aug...
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