Frequent Blood Glucose Measurements Research Articles

Comparison of Methods and Verification of Some Performance Characteristics of Accu-Chek® Instant Glucose Meter

Introduction: Frequent and accurate blood glucose measurements and control can delay the onset of diabetic complications. This is facilitated by the use of point-of-care glucose meters (POCGM). There is a need to verify some claims made by manufacturers of POCGM with regard to accuracy, precision and linearity. We compared blood glucose results obtained from Accu-Check Instant blood glucose meters with laboratory results as reference in order to verify some of these claims. Method: This prospective analytical study involved the verification of some characteristics of Accu-Chek Instant POCGM using different concentrations of glucose calibrators prepared in-house. Blood was obtained from volunteers who had no need for an overnight fast. It was tested using Accu-Chek Instant POCGM and routine laboratory glucose oxidase method as reference and compared using the Bland-Altman plot. Statistical significance was set at p<0.05 Results: There were188 blood samples tested using the two methods. The difference between the means of glucose values from the two methods was 10.3 mg/dL (12.8%) with Accu-Chek POCGM returning higher results than the routine laboratory method. The difference was not statistically significant using the Bland-Altman plot (p=0.60). The analytical range of the POCGM was determined to be between 20mg/dl to 300 mg/dL. Results indicating ‘Hi’ on the POCGM were below 600 mg/dL contrary to what was claimed by the manufacturer. Conclusions and Implications: There was some level of agreement between the two methods studied. Results obtained at high glycaemic states may be more precise but are lower than central laboratory values.

Burden of care and a sense of loneliness in caregivers of children with type 1 diabetes. a cross-sectional study

BackgroundTreatment of type 1 diabetes is a process involving not only sick children, but also their caregivers.AimTo assess the burden of care and sense of loneliness in caregivers of children with type 1 diabetes. Also, an analysis was conducted of the connection between sociodemographic factors characterizing caregivers and the clinical factors characterizing sick children and between the burden of care and the sense of loneliness.Materials and methodsThe study included 125 caregivers of children with type 1 diabetes. In order to collect the research data, the Caregiver Burden Scale and the Revised UCLA Loneliness Scale were used.ResultsIn the research group, the total result in the caregiving burden scale was 2.14, which remains within the average burden level. Caregivers showed the highest burden level in the General Strain Subscale. The analysis showed that mothers experience a greater burden of care than fathers in the General Strain Subscale and that caregivers of younger children are more burdened with care within the Isolation and Disappointment Subscales. Moderate high degree of loneliness was shown in 4.8% of caregivers. A higher burden of care for caregivers of children with type 1 diabetes is accompanied by a higher sense of loneliness.ConclusionsThe results of this study may help healthcare professionals plan a holistic, family-centered care program that will take into account factors that increase the burden of care: younger age of the affected child, motherhood, caregiver unemployment, feelings of loneliness, lower education, caregiver unemployment, blood glucose meter measurements, and frequent night-time blood glucose measurements.

The association between baseline patient characteristics and alpelisib-induced hyperglycaemia in patients with HR+, HER2-, PIK3CA-mutated metastatic breast cancer.

e13059 Background: Alpelisib (A) is a PI3Kα-selective inhibitor and degrader which, in combination with fulvestrant, has been approved for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), PIK3CA-mutated advanced breast cancer (ABC). Hyperglycemia is the most commonly observed adverse event of A. A pooled analysis of X2101 AND SOLAR-1 trials showed the association between five baseline patient characteristics (age, fasting plasma glucose (FPG), glycated haemoglobin, body mass index (BMI) and blood monocyte count (BMC)) and the development of A-induced hyperglycaemia (HG). We examined the association between baseline factors and the A-induced HG grade (G) ≥2 in a real-world setting. Methods: We performed the retrospective observational study and included patients (pts) with HR+, HER2-, PIK3CA-mutated metastatic breast cancer who received A + fulvestrant between Oct 18, 2019, and Oct 13, 2022, at the Institute of Oncology Ljubljana. Electronic records were reviewed. Baseline age, FPG, glycated haemoglobin, BMI and BMC before the start of A therapy and glucose levels during treatment with A were collected. Random plasma glucose values (RPG) were used for HG grading according to CTCAE V. The chi-square test was used to determine the association between the baseline characteristics and A-induced HG G ≥2. Results: Thirty-one female pts were included in the analysis. The median follow-up was 21 months, and the median duration of A treatment was 5.4 months. The baseline pts characteristics were as follows: median age 58 years (range 33–80), median FPG 5.6 mmol/L (range 3.10–8.6), median BMI 21.7 kg/m² (range 18.7–30.4), and median BMC was 10.3% (range 5.3–16.6). Baseline glycated haemoglobin values were only known for 58.1% of patients, so we did not further analyse them. The highest HG grades during treatment with A were as follows: G0 in 14 pts (45.2%), G1 in 5 pts (16.1%), G2 in 6 pts (19.4%), G3 in 6 pts (19.4 %). The calculated cut-off values associated with A-induced HG ≥2 were: age above 65 years, FPG above 5.9 mmol/L and BMC more than 11.5. None of the BMI cut-off values was associated with HG G≥2. Association between the baseline age, FPG and BMC and A-induced HG G≥2. Conclusions: Age over 65 years, FPG more than 5.9 mmol/L and BMC more than 11.5% have a statistically significant higher probability for A-induced HG G≥2. Therefore, these patients need more frequent blood glucose measurements, lifestyle adjustments and early treatment with metformin and/or other oral glucose-lowering agents. [Table: see text]

681-P: Evaluation of Data Processing Performance for Subcutaneous Glucose Monitoring with an Optical Investigational Device

Background and Aims: Lumee Glucose is a small soft glucose-sensitive hydrogel (5.0 x 0.75 x 0.65mm hydrated) currently in clinical development and intended for permanent subcutaneous placement by injection to continuously monitor glucose. The sensor is comprised of a hydrogel scaffold containing fluorescent molecules that produce near infrared light proportional to glucose concentration when interrogated by an optical skin reader placed over the hydrogel. The reader utilizes a set of LEDs to excite the fluorophores within the hydrogel and communicates wirelessly with a tablet. Machine learning and quality data processing algorithms are also being assessed to establish monitoring accuracy using MARD. Methods: Glucose monitoring including a carbohydrate-rich meal was conducted during 8-hour in-clinic visits in 28 subjects with insulin-treated diabetes (female, 48 yrs [20-82], BMI 26.2kg/m2 [19.7-40.3]) over a 3-month period. Frequent venous blood glucose measurements were obtained as reference (Super GL analyzer) . Sensor signals from a total of 188 monitoring traces and 3030 paired values were subjected to retrospective data processing with 3-point glucose reference calibration using machine learning and quality filters to remove potentially compromised optical signals. Results: The average MARD for all 3030 paired values during the 6 to 91-day monitoring period was 12.3%. The MARD was 11.8% when applying additional signal quality filters. Conclusions: Following injection, the hydrogel is suitable for long-term non-invasive glucose monitoring for a minimum period of three months. Projected performance parameters are within the range of currently available glucose monitoring devices. Quality signal processing algorithms revealed marginal performance improvements and should be further optimized with respect to compensating for signal perturbations resulting from motion, temperature, and ambient light changes. Disclosure J.K.Mader: Advisory Panel; Abbott Diabetes, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Speaker’s Bureau; Abbott Diabetes, Eli Lilly and Company, Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Servier Laboratories, Stock/Shareholder; decide Clinical Software GmbH. K.Rebrin: Stock/Shareholder; Profusa, Inc. R.Siegl: None. A.K.Reinhard: None. J.Kopanz: None. A.Simic: None. M.Hartmann: None. S.J.Gamsey: None. S.Banerjee: None. U.Kamecke: Consultant; Profusa, Inc.

Evaluation of the achievement of target glycemic levels in children and adolescents with type 1 diabetes mellitus with insulin pump therapy according to a modified training program

Background. Currently, there is no specialized structured program in the world for group training of patients with type1 diabetes mellitus receiving insulin pump therapy. The purpose of this work was to evaluate the effectiveness of a modified training program in achieving target glycemic levels in children and adolescents with type 1 diabetes mellitus on insulin pump therapy. Material and methods. The training was carried out at the “School of type 1 diabetes mellitus” at the Children’s Clinical Hospital No. 2 in Almaty on an outpatient basis for five days. During the training, a modified program was used, which included all training sections. The survey enrolled 125 children and adolescents with type 1 diabetes mellitus, 68 of them were included in the group of a modified educational program, who studied annually at the “School of type 1 diabetes mellitus”. The group without training (controls) consisted of 57 children and adolescents with type 1 diabetes mellitus, who were trained at the “School of type 1 diabetes mellitus” by the traditional method. All subjects were tested on the basis of a questionnaire, which included 30 key questions on self-control of insulin pump therapy and bread units before and after training. Results. Sixty-eight patients with a modified training program were divided into two subgroups depending on the method of assessing glycemia. The compensation was evaluated by determining the level of glycated hemoglobin (HbA1c). Target therapy levels were better in the modified learning groups than in the control group, which confirms the greater role of motivated parents in the control of type 1 diabetes mellitus, with frequent blood glucose measurements on FreeStyle Libre sensors. Conclusions. The creation of a modified structured training program for patients with type 1 diabetes mellitus, taking into account individual characteristics, as well as cultural and national traditions, is relevant and timely.

Variation of Mean Absolute Relative Differences of Continuous Glucose Monitoring Systems Throughout the Day.

There is an increasing use of continuous glucose monitoring (CGM) by people with diabetes. Measurement performance is often characterized by the mean absolute relative difference (MARD). However, MARD is influenced by a number of factors and little is known about whether MARD is stable throughout the day. A total of 24 participants with type 1 diabetes were enrolled in the study. The study was performed for seven in-patient days. Participants wore two CGM systems in parallel and performed additional frequent blood glucose (BG) measurements. On two days, glucose excursions were induced.MARD was calculated between pairs of CGM and BG values, with BG values serving as reference values. ARD values calculated from CGM-BG pairs were grouped by hour of the day. Results were analyzed separately for glucose excursion days and for regular days. Total MARDs for the complete study duration were 12.5% ± 3.6% and 13.2% ± 2.4% (n = 24). Throughout the day marked variability of MARD was observed (8.0% ± 1.3%-16.3% ± 2.9% (G5); 9.1% ± 1.4%-16.3% ± 5.3% (FL), up to n = 157 each). Low(est) MARD values were observed before breakfast and dinner, when subjects were in or near a fasting state. Especially after breakfast and lunch, MARD values were higher than average. Analytical performance of the two CGM systems, assessed by MARD, was found to vary markedly throughout the day. Activities of daily life likely triggered these variations. An increasing number of CGM users base therapeutic decisions on CGM values, and they should be aware of these variations of performance throughout the day.

Biomaterial Applications in Islet Encapsulation and Transplantation.

The worldwide prevalence of type 1 diabetes motivates the development of different treatment options for the disease. Current clinical treatments typically require patient involvement, often resulting in stress or inconvenience to the patient due to frequent blood glucose measurements and insulin injections or infusions. Islet transplantation, a potentially curative treatment, is limited by donor availability and the need for long-term administration of immunosuppressants. Cell encapsulation may prevent graft rejection without immunosuppression, however, foreign body responses, mass transfer limitations, scalability, and safety are all significant challenges. This Spotlight paper summarizes our recent efforts to address these challenges including developing biomaterials to mitigate foreign body responses and fibrosis, engineering scalable and retrievable encapsulation devices, as well as designing oxygen supplementation and vascularization strategies.

Insulin Therapy in Adults with Type 1 Diabetes Mellitus: a Narrative Review.

Here, we review insulin management options and strategies in nonpregnant adult patients with type 1 diabetes mellitus (T1DM). Most patients with T1DM should follow a regimen of multiple daily injections of basal/bolus insulin, but those not meeting individual glycemic targets or those with frequent or severe hypoglycemia or pronounced dawn phenomenon should consider continuous subcutaneous insulin infusion. The latter treatment modality could also be an alternative based on patient preferences and availability of reimbursement. Continuous glucose monitoring may improve glycemic control irrespective of treatment regimen. A glycemic target of glycated hemoglobin < 7% (53 mmol/mol) is appropriate for most nonpregnant adults. Basal insulin analogues with a reduced peak profile and an extended duration of action with lower intraindividual variability relative to neutral protamine Hagedorn insulin are preferred. The clinical advantages of basal analogues compared with older basal insulins include reduced injection burden, better efficacy, lower risk of hypoglycemic episodes (especially nocturnal), and reduced weight gain. For prandial glycemic control, any rapid-acting prandial analogue (aspart, glulisine, lispro) is preferred over regular human insulin. Faster-acting insulin aspart is a relatively new option with the advantage of better postprandial glucose coverage. Frequent blood glucose measurements along with patient education on insulin dosing based on carbohydrate counting, premeal blood glucose, and anticipated physical activity is paramount, as is education on the management of blood glucose under different circumstances.Plain Language Summary: Plain language summary is available for this article.

Challenges of pancreas transplantation in developing countries, exploring the Turkey example.

Pancreas transplantation significantly improves the quality of life for people with type 1 diabetes, primarily by eliminating the need for insulin and frequent blood glucose measurements. Despite the growing numbers of solid organ transplantations worldwide, number of pancreas transplantations in the developing countries` remain significantly low. This difference of pancreas transplantation practices was striking among the participating countries at the 1st International Transplant Network Meeting which was held in Turkey on 2018. In this meeting more than 40 countries were represented. Most of these counties were developing countries located in Africa, Middle East or Asia. The aim of this article is to identify the challenges and limiting factors for pancreas transplantations in these developing countries, by exploring the Turkish example. The challenges faced by the developing countries are broadly classified in four categories; wait-listing, donor pool, team work and follow up. Under these categorical titles, issues are further discussed in detail, giving examples from Turkish practice of pancreas transplantation. Additionally, several solutions to these challenges have been proposed- some of which have already been undertaken by the Turkish Ministry of Health. With the insight and methods presented in this article, pancreas transplantation should be made possible for the potential recipients in the developing countries.

Ratio of Blood Glucose Level Change Measurement for Flap Monitoring.

Background:In a setting of flap congestion, early detection and rapid reexploration are important. Some studies described the efficacy of blood glucose measurement for flap monitoring.1 However, the sensitivity and specificity of this method were not high enough to determine whether reexploration should be done or not. The purpose of this study was to evaluate and establish a method using the ratio of blood glucose level change (RBGC) measurement for detecting venous thrombosis and to propose an algorithm for flap salvage after congestion.Methods:Blood glucose level was measured in 36 free tissue transfers over time postoperatively and RBGC was calculated. When flap congestion was suspected, frequent blood glucose measurement and some countermeasures were performed complying with an algorithm. If the venous thrombus was suspected, the reexploration was performed. The RBGCs at the points in time when the venous thrombosis was detected were compared with those at the points in time when the flap demonstrated no venous thrombosis.Results:Of the 36 flaps, 30 flaps demonstrated no venous thrombosis and 6 flaps demonstrated venous thrombosis. Four flaps demonstrated signs of congestion but improved after the reexploration. The mean RBGCs at the points in time when the venous thrombosis was detected was −7.61 mg/dl h and those at times when the flap demonstrated no venous thrombosis was 0.10 mg/dl h, the former being significantly lower than the latter.Conclusion:Using the flap monitoring method using RBGC measurement, we could salvage some flaps from the congestion due to the venous thrombosis without unnecessary reexploration.

Performance of a Factory-Calibrated Real-Time Continuous Glucose Monitoring System Utilizing an Automated Sensor Applicator.

This study assessed the accuracy of a factory-calibrated 10-day real-time continuous glucose monitoring (CGM) system (G6), which includes an automated sensor applicator. Seventy-six participants with insulin-treated diabetes were enrolled at four U.S. sites as part of a larger study of G6 system performance. In-clinic visits for frequent comparative blood glucose measurements using a reference instrument (YSI) were conducted on days 1, 4-5, 7, and/or 10 of system use. Accuracy evaluation included the proportion of CGM values that were within ±20% of YSI reference value for glucose levels >100 mg/dL and ±20 mg/dL for YSI glucose levels ≤100 mg/dL (%20/20), the analogous %15/15 and %30/30, and the mean absolute relative difference (MARD) between temporally matched CGM and YSI values. Participants calibrated the systems once daily. Raw sensor data were reprocessed using assigned sensor codes and a factory-calibration algorithm. Reprocessed data from 62 participants (25 adults and 37 children and adolescents of ages 6-17 years; 3532 YSI-CGM pairs) were analyzed. The G6 system's overall %20/20 was 93.9% (adults, 92.5%; children and adolescents, 96.2%), its %15/15 was 83.3% (adults, 78.3%; children and adolescents, 91.1%), and its MARD was 9.0% (adults, 9.8%; children and adolescents, 7.7%). Overall day-1 %20/20 accuracy was 92.2%, %15/15 was 81.5%, and MARD was 9.3%. Accuracy was maintained across 10 days of use and various glucose concentration ranges in both adults and children and adolescents. The G6 system utilizing an automated sensor applicator provides accurate glucose readings in adults and children and adolescents throughout the 10-day sensor life.

Improving Strength, Power, Muscle Aerobic Capacity, and Glucose Tolerance through Short-term Progressive Strength Training Among Elderly People.

This protocol describes the simultaneous use of a broad span of methods to examine muscle aerobic capacity, glucose tolerance, strength, and power in elderly people performing short-term resistance training (RET). Supervised progressive resistance training for 1 h three times a week over 8 weeks was performed by RET participants (71±1 years, range 65-80). Compared to a control group without training, the RET showed improvements on the measures used to indicate strength, power, glucose tolerance, and several parameters of muscle aerobic capacity. Strength training was performed in a gym with only robust fitness equipment. An isokinetic dynamometer for knee extensor strength permitted the measurement of concentric, eccentric, and static strength, which increased for the RET group (8-12% post- versus pre-test). The power (rate of force development, RFD) at the initial 0-30 ms also showed an increase for the RET group (52%). A glucose tolerance test with frequent blood glucose measurements showed improvements only for the RET group in terms of blood glucose values after 2 h (14%) and the area under the curve (21%). The blood lipid profile also improved (8%). From muscle biopsy samples prepared using histochemistry, the amount of fiber type IIa increased, and a trend towards a decrease in IIx in the RET group reflected a change to a more oxidative profile in terms of fiber composition. Western blot (to determine the protein content related to the signaling for muscle protein synthesis) showed a rise of 69% in both Akt and mTOR in the RET group; this also showed an increase in mitochondrial proteins for OXPHOS complex II and citrate synthase (both ~30%) and for complex IV (90%), in only the RET group. We demonstrate that this type of progressive resistance training offers various improvements (e.g., strength, power, aerobic capacity, glucose tolerance, and plasma lipid profile).

Bedside Blood Glucose Monitoring in Critically Ill Patients: Comparison Between Arterial and Capillary Glucose

BackgroundCritically ill patients are at high risk of hypoglycemia and are particularly vulnerable to unrecognized hypoglycemia. Close blood glucose monitoring is therefore crucial. There are several options to conduct frequent blood glucose measurement and a number of conditions in intensive care unit patients may affect the accuracy of blood glucose measurement. The aim of the study was to compare the accuracy of capillary glucose by bedside glucometer with arterial samples by bedside glucometer and arterial samples by blood gas analyzer in critically ill patients through a prospective case-control study. Materials and MethodsArterial and capillary samples from 60 patients were taken simultaneously and were tested immediately at the bedside. Results of the paired measurements were compared and expressed as a correlation coefficient. ResultsCapillary glucose in the study group and control group were 9.73 ± 2.28mmol/L and 8.9 ± 1.86mmol/L, respectively; mean arterial glucose measured by glucometer in the study group and control group were 9.25 ± 2.05mmol/L and 8.4 ± 1.89mmol/L, respectively; and mean arterial glucose measured by blood gas analyzer in the study group and control group were 8.41 ± 1.9mmol/L and 8.24 ± 1.5mmol/L, respectively. Correlation between capillary values and arterial values measured by glucometer was less in the study group (r = 0.936, P < 0.001 and r = 0.973, P < 0.001). Correlation between capillary values measured by glucometer and arterial values measured by blood gas analyzer was also less in the study group (r = 0.897, P = 0.001 and r = 0.964, P < 0.001). ConclusionsCapillary blood glucose monitoring is reliable only in a selected group of critically ill patients.

Patients' attitudes to the use of modern technologies in the treatment of diabetes.

BackgroundThe incidence of diabetes is rising across the world. This global problem significantly affects the economic and social development in the 21st century. If the disease is diagnosed in time, the number of complications as well as the costs of therapy will be lower. Modern technologies permeate all spheres of medicine, and diabetes treatment is no exception. Therefore, the aim of this article is to analyze patients’ attitudes to the use of modern technologies in the treatment of diabetes (type 1 diabetes mellitus [T1DM] and type 2 diabetes mellitus [T2DM]).MethodsA total of 313 respondents from the Czech Republic in the period from June 24, 2015, to July 24, 2015, participated in a questionnaire survey. The target group was diabetics regardless of the type of illness. Collected data were analyzed using descriptive statistical methods, Z-test, and test of independence (Pearson’s chi-squared test).ResultsAlthough in other areas mobile applications are used to monitor patients’ health condition in ~30% of cases, in the case of diabetes they are used by only 4% of respondents. Approximately 8% of participants use an application, but they do not like it. The rest of the respondents have never used any mobile application. These low figures are due to a lack of knowledge about the availability and possibilities of mobile applications. A positive correlation was proven between technical skills and methods of entering data. Gender and age show only a weak dependency of the method of writing data on their own health condition. Furthermore, the monitored parameters show that patients with T1DM control and know more about their health condition than patients with T2DM, which is reflected, for example, by more frequent blood glucose measurements or larger track of their physical activity. Conversely, the relationship between the associated complications and self-care activities has not been demonstrated.ConclusionDespite the current fast development of modern technologies, these technologies are not frequently used in treating patients. The principal problem lies in patients’ low technological knowledge and their higher age, which makes learning new skills, including the use of modern technologies, more difficult.

Multicenter Observational Study of the First-Generation Intravenous Blood Glucose Monitoring System in Hospitalized Patients.

Current methods of blood glucose (BG) monitoring and insulin delivery are labor intensive and commonly fail to achieve the desired level of BG control. There is great clinical need in the hospital for a user-friendly bedside device that can automatically monitor the concentration of BG safely, accurately, frequently, and reliably. A 100-patient observation study was conducted at 6 US hospitals to evaluate the first generation of the Intravenous Blood Glucose (IVBG) System (Edwards Lifesciences LLC & Dexcom Inc). Device safety, accuracy, and reliability were assessed. A research nurse sampled blood from a vascular catheter every 4 hours for ≤ 72 hours and BG concentration was measured using the YSI 2300 STAT Plus Analyzer (YSI Life Sciences). The IVBG measurements were compared to YSI measurements to calculate point accuracy. The IVBG systems logged more than 5500 hours of operation in 100 critical care patients without causing infection or inflammation of a vein. A total of 44135 IVBG measurements were performed in 100 patients with 30231 measurements from the subset of 75 patients used for accuracy analysis. In all, 996 IVBG measurements were time-matched with reference YSI measurements. These pairs had a mean absolute difference (MAD) of 11.61 mg/dl, a mean absolute relative difference (MARD) of 8.23%, 93% met 15/20% accuracy defined by International Organization for Standardization 15197:2003 standard, and 93.2% were in zone A of the Clarke error grid. The IVBG sensors were exposed to more than 200 different medications with no observable effect on accuracy. The IVBG system is an automated and user-friendly glucose monitoring system that provides accurate and frequent BG measurements with great potential to improve the safety and efficacy of insulin therapy and BG control in the hospital, potentially leading to improved clinical outcomes.

Modification of severe insulin resistant diabetes in response to lifestyle changes in Alström syndrome

BackgroundAlström syndrome is a recessively inherited condition characterised by severe insulin resistance and metabolic syndrome with progression to type 2 diabetes, hepatic dysfunction and coronary artery disease. The metabolic responses to lifestyle changes in the syndrome have not been reported. Case reportsWe describe the effects on glycaemia of intense cycling in two insulin treated Alström patients with diabetes, and the effects of opposite lifestyle changes over one year in two others. MethodsAfter practise and clinical assessment two patients aged 21 and 39 years undertook a 380 km cycle ride over 4 days by tandem. The effects of planned reductions in insulin therapies and increased regular carbohydrate ingestion were monitored by frequent capillary blood glucose measurements. Two siblings aged 22 and 25 years underwent assessment of glycaemia, C-peptide/glucose ratio serum lipids, hepatic function and ultrasound, Enhanced Liver Fibrosis test and measures of insulin resistance. Measurements were repeated one year later after profound lifestyle changes. ResultsAerobic exercise strikingly improved blood glucose control despite reduction in insulin dose and increased carbohydrate intake. Increase in exercise and exclusion of fast foods improved all aspects of the metabolic syndrome and induced remission of diabetes in one sibling. Reduction in exercise and consumption of high energy foods in the other resulted in development of type 2 diabetes, severe metabolic syndrome and fatty liver in the other. ConclusionsDespite dual sensory loss and genetic basis for insulin resistance, Alström patients can successfully ameliorate the metabolic syndrome with lifestyle changes.

Feasibility of Factory Calibration for Subcutaneous Glucose Sensors in Subjects With Diabetes.

Continuous glucose monitoring using subcutaneously inserted sensors currently requires blood glucose tests for sensor calibration. Alternatively, sensors precalibrated during the manufacturing process may eliminate the need for fingerstick calibrations. In this study we evaluated the feasibility of sensor factory calibration in subjects with diabetes. A total of 33 subjects with diabetes were asked to wear 4 sensors in parallel, 2 on the arm and 2 on the abdomen. Sensors from a lot with low in vitro sensitivity coefficient of variation were used in the study. Based on frequent capillary blood glucose measurements, the average glucose sensitivity of each sensor was determined over a 5-day wear time. The in vivo sensitivities were analyzed for inter- and intrasubject variation. Mean absolute relative difference (MARD) calculation and consensus error grid analysis (EGA) were performed using a single calibration factor for all sensors, to simulate factory calibration and compared against conventional finger-stick calibration. The sensitivity coefficient of variation between sensors increased from 2.9% in vitro to 6.0% in vivo. No difference in sensor response between subjects (P = .069) as well as between insertion sites (arm and abdomen) was detected (P = .104). Applying one calibration factor to all sensors in the study resulted in an MARD of 13.4%, and 83.5% of the values fell in consensus EGA zone A. Multiple fingerstick calibration resulted in an MARD of 12.7% and 84.1% in zone A. Feasibility of factory calibration was demonstrated in subjects with diabetes using sensors based on "wired enzyme" technology, resulting in accuracy metrics similar to sensors calibrated with capillary blood glucose.

From In- to Out-patient Artificial Pancreas Studies: Results And New Developments

The Artificial Pancreas (AP) is a device for closed-loop modulation of insulin infusion, aiming to maintain patient glycemia in a nearly normal range. In the last decade AP prototypes using subcutaneous glucose sensing and subcutaneous insulin delivery have been extensively studied in clinical trials involving hospitalized patients. To ensure the highest level of patient safety, these studies usually employed very structured protocols and subcutaneous glucose measurements were accompanied by frequent and accurate blood glucose measurements via intravenous sampling. Therefore, in-patient studies were usually short and patients were often unable to move freely. The next step in the AP development is testing safety and efficacy of AP in a real-life scenario, outside the hospital environment and free of strict protocol prescriptions. This paper offers a review of some technological and algorithmic challenges posed by the in-to out-patient transition and reports the authors' experience in making this transition possible. Issues related to devices, telemedicine and control algorithms are discussed and outpatient clinical results are presented in support.

Clinical Evaluation of a Personalized Artificial Pancreas

OBJECTIVEAn artificial pancreas (AP) that automatically regulates blood glucose would greatly improve the lives of individuals with diabetes. Such a device would prevent hypo- and hyperglycemia along with associated long- and short-term complications as well as ease some of the day-to-day burden of frequent blood glucose measurements and insulin administration.RESEARCH DESIGN AND METHODSWe conducted a pilot clinical trial evaluating an individualized, fully automated AP using commercial devices. Two trials (n = 22, nsubjects = 17) were conducted using a multiparametric formulation of model predictive control and an insulin-on-board algorithm such that the control algorithm, or “brain,” can be embedded on a chip as part of a future mobile device. The protocol evaluated the control algorithm for three main challenges: 1) normalizing glycemia from various initial glucose levels, 2) maintaining euglycemia, and 3) overcoming an unannounced meal of 30 ± 5 g carbohydrates.RESULTSInitial glucose values ranged from 84–251 mg/dL. Blood glucose was kept in the near-normal range (80–180 mg/dL) for an average of 70% of the trial time. The low and high blood glucose indices were 0.34 and 5.1, respectively.CONCLUSIONSThese encouraging short-term results reveal the ability of a control algorithm tailored to an individual’s glucose characteristics to successfully regulate glycemia, even when faced with unannounced meals or initial hyperglycemia. To our knowledge, this represents the first truly fully automated multiparametric model predictive control algorithm with insulin-on-board that does not rely on user intervention to regulate blood glucose in individuals with type 1 diabetes.

Failure to Control Hyperglycemia in NonCritically Ill Diabetes Patients despite Standard Glycemic Management in a Hospital Setting

Successful control of hyperglycemia has been shown to improve outcomes for diabetes patients in a clinical setting. We assessed the quality of physician-based glycemic management in two general wards, considering the most recent recommendations for glycemic control for noncritically ill patients (<140 mg/dl for premeal glucose). Quality of glycemic management of 50 patients in two wards (endocrinology, cardiology) was assessed retrospectively by analyzing blood glucose (BG) levels, the glycemic management effort, and the online questionnaire. Glycemic control was clearly above the recommended target (mean BG levels: endocrinology: 175 ± 62 mg/dl; cardiology: 186 ± 68 mg/dl). When comparing the first half with the second half of the hospital stay, we found no difference in glycemic control (endocrinology: 168 ± 32 vs 164 ± 42 mg/dl, P = .67; cardiology: 174 ± 36 mg/dl vs 170 ± 42 mg/dl, P =.51) and in insulin dose (endocrinology: 15 ± 14 IU vs 15 ± 13 IU per day, P = .87; cardiology: 27 ± 17 IU vs 27 ± 18 IU per day, P = .92), despite frequent BG measurements (endocrinology: 2.7 per day; cardiology: 3.2 per day). A lack of clearly defined BG targets was indicated in the questionnaire. The recommended BG target range was not achieved in both wards. Analysis of routine glycemic management demonstrated considerable glycemic management effort, but also a lack of translation into adequate insulin therapy. Implementation of corrective measures, such as structured treatment protocols, is essential.