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Home blood glucose monitoring as an aid in diabetes management.

Home blood glucose monitoring, using Dextrostix and an Eyetone meter, has been utilized in several subcategories of patients with insulin-dependent diabetes mellitus. These include pregnant patients, anephric patients, patients undergoing weight reduction, patients with altered renal threshold for glucose reabsorption, and patients in whom diabetic regulation is difficult. Patients monitored home blood glucose continually (on a daily basis), intermittently, or only for particular problems or symptoms. Such monitoring can be practically accomplished in a manner acceptable to patients. Motivation, compliance with protocol, and an understanding of the objectives of the program are essential on the part of the patient. Home blood glucose monitoring, however, can provide an insight diabetes regulation that cannot be attained in any other way and can greatly facilitate regulation of diabetes. Such home blood glucose monitoring may increase the likelihood of achievement of a degree of control approximating euglycemia.

Adolescent↗

Prandial glycaemia after a carbohydrate-rich meal in type I diabetic patients: using the rapid acting insulin analogue [Lys(B28), Pro(B29)] human insulin.

The time-action profile of the insulin analogue insulin lispro ([Lys(B28), Pro(B29)] human insulin) with its rapid onset and short duration of action might be more suitable to limit hyperglycaemic excursions after a meal rich in rapidly absorbable carbohydrates in comparison to regular human insulin. A randomized, double-blind study was performed in 10 Type I diabetic patients with good metabolic control (HbA1c 7.0 +/- 0.5%). After a baseline period of 3 h (blood glucose clamped at 6.7 mmol l-1, i.v. insulin infusion of 0.2 mU kg-1 min-1 throughout the study), the patients ate a pizza, drank a cola and had a carbohydrate-rich dessert (total carbohydrate content 140 g). Immediately before the meal 15.4 +/- 3.5 U of either insulin preparation were injected subcutaneously. Blood glucose concentrations were monitored continuously thereafter. Following the injection of insulin lispro the area under the blood glucose curve after the meal was 78% of that of regular insulin (1.76 +/- 0.34 vs 2.26 +/- 0.68 mol l-1 *240 min-1; p < 0.01). Maximal blood glucose excursions were higher and were reached later after regular insulin as compared to insulin lispro (11.9 +/- 2.8 vs 9.9 +/- 1.4 mmol l-1; p < 0.05; 66 +/- 37 vs 41 +/- 7 min; p < 0.05). Maximal individual differences in the blood glucose excursions (regular human insulin minus insulin lispro) were 4.8 +/- 2.2 mmol l-1 (p < 0.0001 against zero) after 110 +/- 37 min. In Type 1 diabetic patients prandial blood glucose excursions after a carbohydrate rich meal were reduced after preprandial injection of insulin lispro in comparison to human regular insulin.

Adult↗

Physiologic monitoring of blood glucose.

The technique of continuous chemical analysis in vivo gives promise of real value in medicine. Applied to physiologic monitoring of blood glucose, it provides an invaluable tool for the study of labile diabetes and metabolic problems. Its use during surgical procedures and in post-operative management of such patients and in teaching is to be encouraged.

Appointments and Schedules↗

Continuous blood glucose analysis in vitro and in vivo.

A practical method for continuous blood glucose analysis in vivo is described. Using an interference-free enzyme reagent in a modified Auto-Analyzer whole blood glucose concentration can be monitored continuously and interpreted in terms of the actual plasma glucose concentration. The method uses a novel technique for preheating the sample diluent without introducing additional time delays, consumes whole blood at a rate of 0.05 ml/min, and demonstrates a transport delay of 148 s. Other improvements include an average baseline drift of -0.11 mg/dl/h and a mean change in sensitivity of -0.4% after 8.5 h. In vitro glucose recovery studies comparing whole blood to the corresponding plasma samples show the method is precise (101.3 +/- 0.7%), linearly proportional (slope of 1.007 +/- 0.012) and highly correlated (greater than 0.998) over the range of 0 to 500 mg/dl, with reference to a Beckman glucose analyzer. In vivo applications are presented to show that this method is suitable for us in systems such as the 'artificial endocrine pancreas'.

Autoanalysis↗

Clinical performance of CGMS in type 1 diabetic patients treated by continuous subcutaneous insulin infusion using insulin analogs.

OBJECTIVE: Performance criteria have been established for in vitro blood glucose monitoring, particularly for the self-monitoring of blood glucose using glucose meters. Devices intended for use in the future, such as the continuous glucose monitoring system (CGMS), should satisfy similar criteria, particularly in diabetic patients under intensive therapy. RESEARCH DESIGN AND METHODS: The analysis was conducted on 18 type 1 diabetic patients (not controlled, HbA(1c) >7.5%) treated by external pump using insulin analogs. Each patient received a glucose sensor for 3 days during his/her hospitalization and was instructed in its operation. Medtronic criteria were used to determine the accuracy of the CGMS. In addition, the data were analyzed according to American Diabetes Association (ADA) criteria, Clarke Error Grid analysis, and method of residuals, with the glucose oxidase method using a Beckman analyzer used as the reference method. Specificity and sensitivity were evaluated from the viewpoint of accuracy in the detection of hypoglycemia. For nine patients, two glucose sensors were simultaneously inserted into an abdominal site to determine the reproducibility of the system. RESULTS-Among the 33 glucose sensors inserted, 6 (18%) were nonfunctional. The mean duration of CGMS recording was 63 +/- 12 h. From all of the 692 sets of data that paired glucose readings and CGMS, the coefficients of correlation ranged from 0.87 to 0.92 and the mean absolute error ranged from 12.8 to 15.7%. The time experienced in hypoglycemia (<55 mg/dl) was reported at 86 +/- 62 min/day. Only 39% of the CGMS values satisfied the ADA precision criteria to within +/-10%, and 19% of these values satisfied the future ADA precision criteria of accuracy to within +/-5%. The means of difference method showed that the CGMS slightly underestimated the plasma glucose values (mean = -12 mg/dl). Error grid analysis showed only 77% of the glucose sensor values were in zone A, and 98.9% were in zones A and B. Two values fell in zone C and a single value fell in zone D. The sensitivity and specificity of the CGMS to detect hypoglycemia were 33 and 96%, respectively. A total of 6666 paired sensor values were recorded with a coefficient of correlation of 0.84 with a coefficient of variation of 8.25%. CONCLUSIONS: CGMS could be useful in routine clinical practice to provide much more information on the glucose profile than intermittent self-monitoring of blood glucose (SMBG). However, CGMS cannot be used as a replacement for glucose meters because it does not satisfy the conventional performance goals set down for in vitro glucose measurements and could therefore lead to clinically incorrect treatment decisions.

Adult↗

In vivo calibration of the subcutaneous amperometric glucose sensors using a non-enzyme electrode.

A new two-point calibration method for the subcutaneous amperometric continuous glucose sensor is reported. The proposed method is based on direct measurement of the background current (I(o)) using a non-enzyme electrode. For in vivo test, three electrodes were implanted in rabbits. Two of the three were identical needle-type enzyme electrodes with perfluorinated polymer outer layers (Pt/enzyme layer/Kel-F/PTFE/Kel-F/Nafion) that were placed in subcutaneous tissue and in a vessel (ear artery), respectively. And one non-enzyme electrode with exactly the same membrane composition as those of other two was in the subcutaneous layer to measure the background current. Implantation in the subcutaneous layer generated many crevices on the protecting layers of the electrodes. The signals from enzyme electrodes were effectively corrected by the measured background current from the non-enzyme electrode. In addition, a telemetric monitoring system was developed and evaluated for in vivo continuous glucose monitoring in order to alleviate the problems of motion artifact.

Algorithms↗

Effect of dietary fibre on blood glucose, plasma immunoreactive insulin, C-peptide and GIP responses in non insulin dependent (type 2) diabetics and controls.

A high fibre and a low fibre breakfast meal were given to eight non insulin dependent diabetics ( NIDD ), and eight controls. Blood glucose response was monitored continuously for three hours and characterized using a straight line model. After the high fibre meal the rates of increase and decrease in blood glucose concentration were slower both in diabetics and controls than after the low fibre meal. The delay time, however, i.e. the time from meal intake to the start of glucose increase, hypothetically corresponding to gastric emptying time, was the same after both test meals. The postprandial glucose increment calculated as the area under the 0-120 min curve was lower after the high fibre meal in the NIDD , but not in the controls. The two-hour C-peptide and gastric inhibitory polypeptide values were lower for the diabetics after the high fibre breakfast. The results indicate a prolonged carbohydrate digestion and/or absorption after high fibre breakfast.

Adult↗

Metabolic effects of pulsatile insulin infusion in the elderly.

The present study investigated the metabolic effects of pulsatile insulin delivery at a pulse rate of 2 + 11 and 2 + 18 min in 7 healthy, elderly subjects (71.4 +/- 2.1 years), submitted to 260 min controlled iv glucose infusion via the Biostator. The endogenous secretion of pancreatic hormones was inhibited by somatostain (3 micrograms/min) and glucagon was replaced (67 ng/min) to basal levels. The same total insulin dose was delivered on both occasions. Insulin infusion rate was 1.3 and 2.0 mIU. kg-1. min-1 during switching on/off of 2 + 11 and 2 + 18 min, respectively. Blood glucose levels and glucose infusion rate were monitored continuously by the Biostator; [D-3-3H]glucose infusion allowed determination of glucose turnover. During the last 60 min of the experiment, pulsatile insulin at a pulse rate of 2 + 11 vs 2 + 18 min produced a stronger inhibition of endogenous glucose production, whereas glucose disappearance rate and glucose metabolic clearance rate were similarly affected. Plasma triglycerides, apolipoprotein B, and free fatty acids levels were also more suppressed during insulin delivery at pulse rate of 2 + 11 than at 2 + 18 min.

Aged↗

Transcutaneous blood glucose monitoring system based on an ISFET glucose sensor and studies on diabetic patients.

A transcutaneous blood glucose monitoring system consists of an ion-sensitive field-effect transistor (ISFET) glucose sensor unit and a suction effusion fluid (SEF) collecting unit. The SEF is directly collected by a weak suction (400 mmHg absolute pressure) through the skin from which the corneum layer of the epidermis has been previously removed. An ISFET glucose sensor unit is able to measure glucose concentrations in a microliter order sampling volume. The system was applied to three diabetic patients during a 75 g oral glucose tolerance test for monitoring blood glucose levels. During the experiments, glucose changes in the SEF followed actual blood glucose levels with 10 min delays. Results suggest the feasibility of utilizing quasi-continuous, transcutaneous blood glucose monitoring for individual patients with various diabetic histories or diabetic complications.

Aged↗

Reduced glycemic response to beet-fibre meal in non-insulin-dependent diabetics and its relation to plasma levels of pancreatic and gastrointestinal hormones.

Standardized breakfasts with or without beet-fibre were given, in random order, to non-insulin-dependent diabetics. The blood glucose levels were monitored continuously and hormonal responses were determined at regular intervals for 3 hr. After the beet-fibre breakfast including 10.8 g dietary fibre from the sugar beet, the glucose plateau level and the area below the curve were lower than after the control meal. The rate of glucose decrease was also slower after the beet-fibre meal. There were no notable differences with regard to the plasma levels of insulin, C-peptide or glucagon. The gastric inhibitory polypeptide response was greater during the first part of the curve, while the somatostatin response after the beet-fibre meal displayed a significantly larger total area below the curve. The results suggest that the diminished glycemic response after the beet-fibre meal is associated with an increased response of somatostatin, giving a reduced glucose absorption and a delayed gastrointestinal transit time.

Aged↗

The use of two continuous glucose sensors during and after surgery.

BACKGROUND: Maintaining plasma glucose between 80 and 120 mg/dL is beneficial for patients admitted to a surgical intensive care unit, but requires frequent glucose monitoring to ensure adequacy of treatment and detection of hypoglycemia. We examined whether continuous glucose sensing is feasible and reliable during and after major surgical procedures using two commercially available sensors. METHODS: Eight patients undergoing abdominal surgery were studied. A CGMS device (Medtronic MiniMed, Northridge, CA) and a GlucoDay device (A. Menarini Diagnostics, Florence, Italy) were placed in the shoulder region, and a second GlucoDay device was placed in the upper leg. Blood glucose was measured every 15 min for a total duration of 12 h. RESULTS: Technical failure of the CGMS was observed peroperatively more frequently than postoperatively (66% of all time points vs. 18%, P < 0.001). Technical failure of the GlucoDay device occurred most frequently in the GlucoDay placed in the upper leg (64% vs. 17%, P < 0.001). Accuracy of all three sensors was comparable peroperatively (74%, 76%, and 63% of values in Zone A of the Clarke error grid for the CGMS, GlucoDay shoulder, and GlucoDay upper leg, respectively, P = 0.2). Postoperatively, better accuracy was observed in both sensors placed in the shoulder compared with the GlucoDay placed in the upper leg (73%, 69%, and 51% of values in Zone A for the CGMS, GlucoDay shoulder, and GlucoDay upper leg, respectively, P < 0.001). CONCLUSIONS: Technical performance and accuracy of continuous glucose sensors need improvement before continuous glucose sensors can be used to monitor strict glycemic control during and after surgery.

Adult↗

Improving diabetic control in adverse social conditions. A home blood glucose monitoring study in Soweto, South Africa.

In order to explore the feasibility of home blood glucose monitoring (HBGM) in Type 1 diabetics in developing countries, we introduced the technique to Type 1 patients below the age of 30 yr attending the Diabetic Clinic serving Soweto in South Africa. Despite initial problems, HBGM with visually-read strips was applied to 45 of the 64 young Type 1 diabetics identified ("HBGM group"). The remaining 19 were continued on urine glucose monitoring only ("HUGM group"), usually because of attendance and compliance problems. After 4 months' follow-up, glycosylated haemoglobin (HbA1) fell from 10.5 +/- 2.6% (mean +/- SD) to 9.0 +/- 1.7 (p less than 0.001) in the HBGM group, but was unchanged (10.1 +/- 2.1 vs 9.9 +/- 1.9, pn.s.) in HUGM patients. HBGM can thus be introduced in adverse social conditions, and may be associated with improved diabetic control. Costs, in terms of finance and medical time, were not excessive. Unfortunately, a significant minority were excluded by attendance and other problems, and analysis of diabetic complication rates (before the programme began) showed that these patients had significantly more complications than those deemed suitable for HBGM (42.1% vs 15.5%, p less than 0.05).

Adult↗

New noninvasive transcutaneous approach to blood glucose monitoring: successful glucose monitoring on human 75 g OGTT with novel sampling chamber.

A novel noninvasive and quasi-continuous method of transcutaneous blood glucose monitoring for use with the human 75 g oral glucose tolerance test (OGTT) has been developed. The effused fluid was obtained by applying suction on the skin surface and labeled suction effusion fluid (SEF). The system consists of two main parts: a suction apparatus and the glucose sensor system. The suction apparatus applies vacuum to the patient's skin at 400 mmHg absolute pressure to collect the SEF. The miniature ion sensitive field effect transistor (ISFET) based glucose sensor can measure glucose in small SEF quantities. The monitoring system is based on the association between the glucose concentration in the SEF and in the serum. During the 75 g OGTT, the glucose change in the SEF was measured every 10 min. Although a response delay of up to 20 min was observed in the SEF glucose change, it was possible to perform the 75 g OGTT by this noninvasive monitoring method.

Animals↗

Pulsatile hyperglucagonemia fails to increase hepatic glucose production in normal man.

To study the metabolic effects of pulsatile glucagon administration, six male volunteers were submitted to a 260-min glucose-controlled glucose intravenous infusion using the Biostator. The endogenous secretion of the pancreatic hormones was inhibited by somatostatin (100 micrograms X h-1), basal insulin secretion was replaced by a continuous insulin infusion (0.2 mU X kg-1 X min-1), and glucagon was infused intravenously in two conditions at random: either continuously (125 ng X min-1) or intermittently (812.5 ng X min-1, with a switching on/off length of 2/11 min). Blood glucose levels and glucose infusion rate were monitored continuously by the Biostator, and classical methodology using a D-[3-3H]glucose infusion allowed us to study glucose turnover. While basal plasma glucagon levels were similar in both conditions (122 +/- 31 vs. 115 +/- 18 pg X ml-1), they plateaued at 189 +/- 38 pg X ml-1 during continuous infusion and varied between 95 and 501 pg X ml-1 during pulsatile infusion. When compared with continuous administration, pulsatile glucagon infusion initially induced a similar increase in endogenous (hepatic) glucose production and blood glucose, did not prevent the so-called "evanescent" effect of glucagon on blood glucose, and after 3 h tended to reduce rather than increase hepatic glucose production. In conclusion, in vivo pulsatile hyperglucagonemia in normal man fails to increase hepatic glucose production.

Adult↗

Computer based quality assessment of hospital capillary blood glucose monitoring.

A quality control (QC) programme to continually monitor the reliability of hospital ward capillary blood glucose levels has been developed based on a memory blood glucose meter interfaced to a portable microcomputer. Over a 38-week period some 12,500 ward QC tests were performed by approximately 200 accredited operators. Although the mean weekly coefficients of variation were all less than 15%, there was a marked variation between wards, with the frequency of testing of patients the major factor influencing reliability. However an external laboratory-based QC programme suggested a high degree of proficiency which was not achieved by any ward on internal QC assessment.

Blood Glucose↗

New strategies for the treatment of gestational diabetes.

The approach to gestational diabetes mellitus has altered markedly in the last decade; it is guided by universal screening and an impetus to establish 24-h euglycemia in these women, through serial measurements of blood glucose by home monitoring and glycated hemoglobin. The best screening and diagnostic procedures for documentation of gestational diabetes remain the subject of considerable debate. Improved outcome has been associated with improved levels of glycemia. While continuous monitoring of blood glucose is not practical, four blood glucose checks per day (fasting and 1 h after the start of each meal) had proven feasible and allowed the development of treatment strategies designed to maintain fasting blood glucose less than 80 mg/dl and post-prandial glucose less than 140 mg/dl. Diet prescriptions that help achieve these goals include a caloric intake sufficient to avoid the ketonuric threshold (30 kcal/kg in women 80-120% ideal body weight) and less than or equal to 40% carbohydrate. Seventy-five percent of women with gestational diabetes respond to diet therapy alone. Cardiovascular conditioning exercise for 20 min three times per week has been shown to be useful in lowering both fasting and post-prandial glucose levels. If diet and exercise do not achieve the requisite glucose levels, insulin therapy based on body weight and gestational age is instituted.

Diabetes, Gestational↗

Pulsatile insulin delivery has greater metabolic effects than continuous hormone administration in man: importance of pulse frequency.

The aim of this study was to see if the greater effect of insulin on hepatic glucose output when insulin is given using 13-min pulses in man remains when the same amount of insulin is delivered using 26-min pulses. The study was performed on nine male healthy volunteers submitted to a 325 min glucose-controlled glucose iv infusion using the Biostator. The endogenous secretion of pancreatic hormones was inhibited by somatostatin. Three experiments were performed in each subject on different days and in random order. In all cases glucagon was replaced (58 ng min-1). The amounts of insulin infused were identical in all instances and were 0.2 mU kg-1 min-1 (continuous), 1.3 mU kg-1 min-1, 2 min on and 11 min off (13-min pulses) or 2.6 mU kg-1 min-1, 2 min on and 24 min off (26-min pulses). Blood glucose levels and glucose infusion rate were monitored continuously by the Biostator, and classic methodology using D-[3-3H] glucose infusion allowed to study glucose turnover. When compared with continuous insulin, 13-min insulin pulses induced a significantly greater inhibition of endogenous glucose production. This effect disappeared when insulin was delivered in 26-min pulses. We conclude that, in man, an adequate pulse frequency is required to allow the appearance of the greater inhibition of pulsatile insulin on endogenous glucose production.

Adult↗