Correlation between plantar foot temperature and diabetic neuropathy: a case study by using an infrared thermal imaging technique

Background

Diabetic neuropathy consists of multiple clinical manifestations of which loss of sensation is most prominent. High temperatures under the foot coupled with reduced or complete loss of sensation can predispose the patient to foot ulceration. The aim of this study was to look at the correlation between plantar foot temperature and diabetic neuropathy using a noninvasive infrared thermal imaging technique.

Methods

Infrared thermal imaging, a remote and noncontact experimental tool, was used to study the plantar foot temperatures of 112 subjects with type 2 diabetes selected from a tertiary diabetes centre in South India.

Results

Patients with diabetic neuropathy (defined as vibration perception threshold (VPT) values on biothesiometry greater than 20 V) had a higher foot temperature (32–35 °C) compared to patients without neuropathy (27–30 °C). Diabetic subjects with neuropathy also had higher mean foot temperature (MFT) (p = .001) compared to non-neuropathic subjects. MFT also showed a positive correlation with right great toe (r = 0.301, p = .001) and left great toe VPT values (r = 0.292, p = .002). However, there was no correlation between glycated hemoglobin and MFT.

Conclusion

Infrared thermal imaging may be used as an additional tool for evaluation of high risk diabetic feet.     

Diabetic Foot Disease: Emerging Technologies: Repeatability of Infrared Plantar Thermography in Diabetes Patients: A Pilot Study

Objective

Infrared (IR) thermography has been used as a complementary diagnostic method in several pathologies, including distal diabetic neuropathy, by tests that induce thermoregulatory responses, but nothing is known about the repeatability of these tests. This study aimed to assess the repeatability of the rewarming index in subjects with type 2 diabetes mellitus (T2DM) and nondiabetic control subjects.

Methods

Using an IR camera, plantar IR images were collected at baseline (pre-) and 10 min after (post-) cold stress testing on two different days with 7 days interval. Plantar absolute average temperatures pre- and post-cold stress testing, the difference between them (ΔT), and the rewarming index were obtained and compared between days. Repeatability of the rewarming index after the cold stress test was assessed by Bland–Altman plot limits of agreement.

Results

Ten T2DM subjects and ten nondiabetic subjects had both feet analyzed. Mean age did not differ between groups (p = .080). Absolute average temperatures of plantar region pre- (p = .033) and post-cold stress test (p = .019) differed between days in nondiabetic subjects, whereas they did not differ in T2DM subjects (pretest, p = .329; post-test, p = .540). ΔT and rewarming index did not differ between days for both groups, and the rewarming index presented a 100% agreement of day-to-day measurements from T2DM subjects and 95% with nondiabetic subjects.

Conclusions

The rewarming index after cold stress testing presented good repeatability between two days a week in both groups. Despite T2DM subjects presenting no differences on absolute temperature values between days, ΔT or rewarming index after cold stress testing remain recommended beside absolute temperature values for clinical use.     

Diabetic Foot Disease: Emerging Technologies: Validation of Plantar Pressure Measurements for a Novel In-Shoe Plantar Sensory Replacement Unit

Background

Research concerning prevention of diabetic foot complications is critical. A novel in-shoe plantar sensory replacement unit (PSRU) has been developed that provides alert-based feedback derived from analyzing plantar pressure threshold measurements in real time. The purpose of this study was to compare the PSRU device to a gold standard pressure-sensing device (GS-PSD) to determine the correlation between concurrent measures of plantar pressure during walking.

Methods

The PSRU had an array of eight sensors with a range of 10–75 mm Hg and collected data at 4 Hz, whereas the GS-PSD had 99 sensors with a range of 1–112 mm Hg and collected data at 100 Hz. Based on an a priori power analysis, data were collected from 10 participants (3 female, 7 male) while walking over ground in both devices. The primary variable of interest was the number of data points recorded that were greater than 32 mm Hg (capillary arterial pressure—the minimum pressure reported to cause pressure ulcers) for each of the eight PSRU sensors and corresponding average recordings from the GS-PSD sensor clusters. Intraclass correlation coefficient (2,1) was used to compare data between the two devices.

Results

Compared with the GS-PSD, we found good-to-very-good correlations (r-value range 0.67–0.86; p-value range 0.01–0.05) for six of the PSRU’s eight sensors and poor correlation for only two sensors (r = 0.41, p = .15; r = 0.38, p = .18) when measuring the number of data points recorded that were greater than 32 mm Hg.

Conclusions

Based on the results of the present study, we conclude the PSRU provides analogous data when compared with a GS-PSD.     

Diabetic Foot Disease: Emerging Technologies: Morphological Pattern Classification System for Plantar Thermography of Patients with Diabetes

Background

A plantar temperature distribution can be obtained by thermography; however, the advantage has not been effectively utilized in the past. We previously proposed a classification method based on the angiosome concept, but the method was insufficient because it was too subjective and complicated for clinicians. In this study, we propose a new classification system of plantar forepart thermographic patterns using an image segmentation technique.

Methods

A cross-sectional observational study was conducted including 32 healthy volunteers and 129 patients with diabetes mellitus (DM). Individual thermographic variations and trends were evaluated. A comparison was conducted between the patterns obtained by our previous angiosome-based research and the patterns found by the new classification system.

Results

The system objectively found wider variations of the plantar forepart thermographic patterns in the patients with DM compared with those in the control subjects. In patients with DM, the system showed that the whole-high pattern was most frequent (46%), followed by the butterfly pattern (12%). In the control group, the butterfly pattern was most frequent (44%), followed by the whole-high pattern (19%). Both ankle and toe brachial indices were higher in feet with high temperature area in the inner side of the plantar.

Conclusions

Thermographic patterns found by the new computer-based system were similar to those obtained in our previous subjective work. The classification system found forefoot-low pattern and tiptoe-low pattern objectively. The system based on infrared thermography will be a screening tool to assess circulatory status in daily foot care of patients with DM.     

A Single-Center, Open, Comparative Study of the Effect of Using Self-Monitoring of Blood Glucose to Guide Therapy on Preclinical Atherosclerotic Markers in Type 2 Diabetic Subjects

Background

The aim of our study was to determine the effect of treatment based on preprandial and postprandial self-monitoring of blood glucose (SMBG) on the progression of carotid intima-medial thickness (CIMT) in noninsulin-treated type 2 diabetes mellitus (T2DM) subjects.

Methods

In this 18-month prospective trial, we recruited subjects 18–70 years of age, treated with metformin and sulfonylurea, with a standardized hemoglobin A1c (HbA1c) level ≤9.0%. Subjects were randomized to use of fasting/preprandial (FP) SMBG results to adjust evening medication or use of postprandial (PP) SMBG results to adjust morning medication. The primary end point was change in CIMT; change in HbA1c was a secondary end point.

Results

Of the 300 subjects randomized, 280 (140 in each group) completed all biochemical tests and CIMT analysis. Carotid intima-medial thickness was reduced significantly in PP subjects from 0.78 (±0.15) mm to 0.73 (±0.14) mm (p < 0.005), but no significant CIMT reduction was seen in FP subjects. A significant reduction in HbA1c was also seen in the PP group (p < 0.005) but not in the FP group 1 (p = 0.165). Significant improvements in body mass index (p = 0.038), waist circumference (p < 0.001), systolic blood pressure (p = 0.008), and serum cholesterol (p = 0.02) were also seen in PP subjects but not in FP subjects.

Conclusion

Use of postprandial SMBG data to adjust therapy was associated with a significant regression of carotid intima-medial thickening and a reduction in HbA1c in T2DM, whereas no significant improvement in these parameters was seen in subjects who used fasting/preprandial SMBG data for therapy adjustment.     

In type 2 diabetes patients, insulin glargine is associated with lower postprandial release of intact proinsulin compared with sulfonylurea treatment

Objective

Our objective was to investigate how postprandial processing of intact proinsulin is influenced by different pharmacological strategies in type 2 diabetes mellitus (T2DM).

Materials/Methods

This exploratory, nonrandomized, cross-sectional study recruited T2DM patients and healthy subjects. Upon recruitment, eligible T2DM patients had been treated for ≥6 months with insulin glargine (GLA) plus metformin (MET), sulfonylureas (SU) plus MET, or dipeptidyl-peptidase-4 inhibitors (DPP-4-I) plus MET. Blood samples were drawn from study participants after an 8 h fast and at regular intervals for up to 5 h after consumption of a standardized meal. Study endpoints included postprandial intact proinsulin and insulin levels and the insulin/proinsulin ratio.

Results

As expected, postprandial secretion of proinsulin was greater in all T2DM treatment groups than in healthy subjects (p < .01 for all comparisons). Postprandial release of proinsulin was significantly greater in T2DM patients treated with SU plus MET than in those treated with GLA plus MET (p = .003). Treatment with DPP-4-I plus MET was associated with reduced proinsulin secretion versus SU plus MET and an increased insulin/proinsulin ratio versus the other T2DM groups.

Conclusions

Treatment of T2DM with GLA plus MET or DPP-4-I plus MET was associated with a more physiological postprandial secretion pattern of the β cell compared with those treated with SU plus MET.     

Foot Technology, Part 1 of 2: Association between Foot Temperature and Sudomotor Dysfunction in Type 2 Diabetes

Background and Aims

Increased foot skin temperature has been described as a feature of diabetic neuropathy. The aim of this present study was to investigate the association between foot temperature and sudomotor dysfunction in type 2 diabetes mellitus.

Patients and Methods

This study included 51 patients (group A: 25 men, mean age 61.14 ± 6.11 years) without sudomotor dysfunction and 52 patients (group B: 25 men, mean age 59.54 ± 6.18 years) with sudomotor dysfunction. Sudomotor dysfunction was defined as time until complete Neuropad^® color change from blue to pink exceeding 600 s in at least one foot. Time until complete color change of the test was also recorded. Foot skin temperature was measured with a handheld infrared thermometer on the plantar aspect of the foot at the level of the first metatarsal head.

Results

On both feet, temperature was significantly higher in group B than in group A (right foot, group A versus group B, 30.62 ± 1.13 °C versus 32.12 ± 1.06 °C, p < .001; left foot, group A versus group B, 30.65 ± 1.06 °C versus 32.19 ± 1.10 °C, p < .001). There was a significant positive correlation between time to complete Neuropad color change and foot skin temperature (right foot, r = 0.742, p < .001; left foot, r = 0.758, p < .001), which was confirmed in both groups.

Conclusions

Patients with sudomotor dysfunction have significantly higher foot temperature than those without sudomotor dysfunction. Foot temperature is positively correlated with severity of sudomotor dysfunction, as evaluated by the time to complete Neuropad color change.     

Plantar fascia thickness is longitudinally associated with retinopathy and renal dysfunction: a prospective study from adolescence to adulthood

Aim

The aim was to study the longitudinal relationship between plantar fascia thickness (PFT) as a measure of tissue glycation and microvascular (MV) complications in young persons with type 1 diabetes (T1DM).

Methods

We conducted a prospective longitudinal cohort study of 152 (69 male) adolescents with T1DM who underwent repeated MV complications assessments and ultrasound measurements of PFT from baseline (1997–2002) until 2008. Retinopathy was assessed by 7-field stereoscopic fundal photography and nephropathy by albumin excretion rate (AER) from three timed overnight urine specimens. Longitudinal analysis was performed using generalized estimating equations (GEE).

Results

Median (interquartile range) age at baseline was 15.1 (13.4–16.8) years, and median follow-up was 8.3 (7.0–9.5) years, with 4 (3–6) visits per patient. Glycemic control improved from baseline to final visit [glycated hemoglobin (HbA1c) 8.5% to 8.0%, respectively; p = .004]. Prevalence of retinopathy increased from 20% to 51% (p < .001) and early elevation of AER (>7.5 µg/min) increased from 26% to 29% (p = .2). A greater increase in PFT (mm/year) was associated with retinopathy at the final assessment (ΔPFT 1st vs. 2nd–4th quartiles, χ² = 9.87, p = .02). In multivariate GEE, greater PFT was longitudinally associated with retinopathy [odds ratio (OR) 4.6, 95% confidence interval (CI) 2.0–10.3] and early renal dysfunction (OR 3.2, CI 1.3–8.0) after adjusting for gender, blood pressure standard deviation scores, HbA1c, and total cholesterol.

Conclusions

In young people with T1DM, PFT was longitudinally associated with retinopathy and early renal dysfunction, highlighting the importance of early glycemic control and supporting the role of metabolic memory in MV complications. Measurement of PFT by ultrasound offers a noninvasive estimate of glycemic burden and tissue glycation.     

Gastric Electrical Stimulation with the TANTALUS? System in Obese Type 2 Diabetes Patients: Effect on Weight and Glycemic Control

Background

The TANTALUS^® System is an investigational device that consists of an implantable pulse generator connected to gastric electrodes. The system is designed to automatically detect when eating starts and only then deliver sessions of gastric electrical stimulation (GES) with electrical pulses that are synchronized to the intrinsic antral slow waves. We report the effect of this type of GES on weight loss and glucose control in overweight/obese subjects with type 2 diabetes mellitus (T2DM). This study was conducted under a Food and Drug Administration/Institutional Review Board-approved investigational device exemption.

Method

Fourteen obese T2DM subjects on oral antidiabetes medication were enrolled and implanted laparoscopically with the TANTALUS System (body mass index 39 ± 1 kg/m², hemoglobin A1c [HbA1c] 8.5 ± 0.2%).Gastric electrical stimulation was initiated four weeks after implantation. Weight, HbA1c, fasting blood glucose, blood pressure, and lipid levels were assessed during the study period.

Results

Eleven subjects reached the 6-month treatment period endpoint. Gastric electrical stimulation was well tolerated by all subjects. In those patients completing 6 months of therapy, HbA1c was reduced significantly from 8.5 ± 0.7% to 7.6 ± 1%, p < .01. Weight was also significantly reduced from 107.7 ± 21.1 to 102.4 ± 20.5 kg, p < .01. The improvement in glucose control did not correlate with weight loss (R² = 0.05, p = .44). A significant improvement was noted in blood pressure, triglycerides, and cholesterol (low-density lipoprotein only).

Conclusions

Short-term therapy with the TANTALUS System improves glucose control, induces weight loss, and improves blood pressure and lipids in obese T2DM subjects on oral antidiabetes therapy.     

Increased Arterial Augmentation and Augmentation Index as Surrogate Parameters for Arteriosclerosis in Subjects with Diabetes Mellitus and Nondiabetic Subjects with Cardiovascular Disease

Background

Arterial augmentation (AP) and the augmentation index (Aix) are surrogate parameters of arterial stiffness and are commonly used as predictors for cardiovascular risk. The aim of this study is to compare these parameters in diabetic subjects and nondiabetic cardiovascular risk subjects with healthy control subjects.

Methods

One hundred sixty-six nonsmoking subjects aged between 35 and 70 years were included in the study, which included 100 subjects with cardiovascular disease but not diabetes (mean age 62.73±8.75 years), 33 subjects with type 2 diabetes (66.58±2.69 years), and 33 healthy controls (51.89±8.91 years). In these subjects, arterial stiffness was measured by the difference between the second and the first systolic peak of the central pressure waveform, and the Aix was calculated as the percentage of Aix from pulse pressure.

Results

Arterial augmentation was increased in subjects with diabetes (DM) with 10.21±6.97 mm Hg and in subjects with cardiovascular disease but not diabetes (CV) with 10.74±5.29 mm Hg in comparison to healthy controls (C) with 6.59±3.97 mm Hg (p < 0.0005 DM vs C; p < 0.00005 CV vs C). Moreover, Aix was increased with 26.00±9.91% in CV subjects compared to healthy controls with 19.84±9.37% (p < 0.02 CV vs C). The augmentation index was increased with 21.12±11.21% in subjects with type 2 diabetes mellitus compared to controls, but failed to be statistically significant. There was no statistical significance in arterial augmentation or the augmentation index between CV and diabetic subjects.

Conclusion

The results of our study revealed a comparable increased augmentation index as a surrogate measure of arterial stiffness and arteriosclerosis in subjects with diabetes mellitus and in nondiabetic subjects with cardiovascular disease.     

The Benefits of Continuous Glucose Monitoring and a Glucose Monitoring Schedule in Individuals with Type 1 Diabetes during Recreational Diving

Background

Our objective is to evaluate the Medtronic CGMS^® continuous glucose monitoring system and plasma glucose (PG) measurement performed in a monitoring schedule as tools to identify individuals with type 1 diabetes at risk when diving.

Methods

We studied 24 adults, 12 type 1 diabetes subjects and 12 controls, during 5 recreational scuba dives performed on 3 consecutive days. The CGMS was used by all participants on all the days and all the dives. Comparisons were made between PG performed in a monitoring schedule during the days of diving, self-monitored blood glucose (SMBG) performed 2 weeks prior to diving, and the CGMS during the study.

Results

One hundred seventeen dives were performed. Hypoglycemia (<70 mg/dl) was found in six individuals and on nine occasions. However, no symptoms of hypoglycemia were present during or immediately postdiving. In one case, repetitive hypoglycemia prediving gave rise to a decision not to dive. None of the dives were aborted. The number of hypoglycemic episodes, 10 min prediving or immediately postdiving, were related to the duration of diabetes, r = 0.83 and p =0.01, and the percentage of SMBG values below target (<72 mg/dl), r = 0.65 and p =0.02. Moreover, the number of hypoglycemic episodes was also related to the total duration below low limit (<70 mg/dl), measured by the CGMS, r =0.74 and p =0.006.

Conclusion

Safe dives are possible to achieve by well-informed, well-controlled individuals with type 1 diabetes. Using downloaded SMBG, CGMS, and repetitive PG in a monitoring schedule, it is possible to identify those subjects who are suitable for diving.     

Pancreatic polypeptide administration enhances insulin sensitivity and reduces the insulin requirement of patients on insulin pump therapy

Introduction

The effects of pancreatic polypeptide (PP) infusion were examined in patients on insulin pump therapy to determine whether PP administration can reduce insulin requirements in patients with type 1 diabetes mellitus (T1DM) or type 3c diabetes mellitus (T3cDM; pancreatogenic).

Methods

Ten subjects with long-standing T1DM (n = 7) or T3cDM (n = 3) on insulin pump treatment received a 72 h subcutaneous infusion of 2 pmol/kg/min bovine PP or saline by portable infusion pump in a single-blinded, randomized, crossover design.

Results

Pancreatic polypeptide infusion raised plasma PP levels to 450–700 pmol/liter. Daily insulin infusion requirements (I) fell from 48 ± 6.9 to 40 ± 7.5 U on day 2 (p < .05) and from 46 ± 7.7 to 37 ± 6.6 U on day 3 (p < .05) of PP infusion compared with saline. Corrected for average blood glucose concentration (G), I/G fell in 10/10 subjects during the second 24 h period and in 7/10 subjects during the third 24 h period; sensitivity to insulin, calculated as 1/(I/G), increased 45% ± 12% on day 2 (p < .01) and 34% ± 14% on day 3 (p < .05) of PP infusion. Pancreatic polypeptide responses to a test meal were compared with the change in insulin infusion requirements in 5 subjects; the reduction in insulin requirements seen during PP infusion correlated with the degree of baseline PP deficiency (p < .002).

Conclusions

A concurrent subcutaneous infusion of PP enhances insulin sensitivity and reduces insulin requirements in patients with long-standing T1DM and T3cDM on insulin pump therapy. The benefit of PP infusion correlated with the degree of PP deficiency.     

Study of the intima-media thickening in carotid arteries of healthy elderly with high blood pressure and elderly with high blood pressure and dyslipidemia

Objective

The objective of this study was to assess the mean intima-media thickening of carotid arteries of elderly subjects, and its relationship with age, anthropometric measurements, high systolic blood pressure and dyslipidemia.

Methods

In this investigation, 129 subjects were enrolled between 1995 and 1998, age ranging from 29 to 94 years. They were assigned to one of 4 groups, including 2 control groups (group I, of healthy younger subjects; group II of healthy elderly subjects). Groups III and IV included those who presented with isolated systolic hypertension (ISH), and ISH and dyslipidemia, respectively. All subjects were submitted to a medical interview, lab tests with measurement of cholesterol levels, electrocardiogram, and carotid ultrasound. The ultrasound included measurement of the intima-media thickening (IMT) of the carotid arteries, the right carotid artery (RCA) and left carotid artery (LCA), and assessment of the presence of plaques. Blood fat and glucose were measured by a standard method. The results were compared among the groups through statistical tests. The tests employed were: Chi-Square, Pearson’s and Likelihood Ratio, Student’s t, Mann-Whitney; ANOVA followed by Tukey’s test, Kruskal-Wallis nonparametric test, and test for multiple comparisons and Odds Ratio determination (OR).

Results

In this investigation, a positive association was observed between aging and IMT. In relation to systolic hypertension, a significant association was observed with IMT (IMT-RCA p = 0.0034; IMT-LCA p = 0.0196; IMT-RLCA p = 0.0299), and with the presence of plaques (PlaqueR p = 0.0110; PlaqueL p = 0.0294; PlaqueRL p = 0.0040).

Conclusion

This investigation evidenced the important role of aging in IMT, and of systolic hypertension in the IMT and presence of plaque. However, further studies are needed for a better understanding of the actual role of risk factors in aging.     

The effect of real-time continuous glucose monitoring on glycemic control in patients with type 2 diabetes mellitus

Background:

Real-time continuous glucose monitoring (RT-CGM) improves hemoglobin A1c (A1C) and hypoglycemia in people with type 1 diabetes mellitus and those with type 2 diabetes mellitus (T2DM) on prandial insulin; however, it has not been tested in people with T2DM not taking prandial insulin. We evaluated the utility of RT-CGM in people with T2DM on a variety of treatment modalities except prandial insulin.

Methods:

We conducted a prospective, 52-week, two-arm, randomized trial comparing RT-CGM (n = 50) versus self-monitoring of blood glucose (SMBG) (n = 50) in people with T2DM not taking prandial insulin. Real-time continuous glucose monitoring was used for four 2-week cycles (2 weeks on/1 week off). All patients were managed by their usual provider. This article reports on changes in A1C 0–12 weeks.

Results:

Mean (±standard deviation) decline in A1C at 12 weeks was 1.0% (±1.1%) in the RT-CGM group and 0.5% (±0.8%) in the SMBG group (p = .006). There were no group differences in the net change in number or dosage of hypoglycemic medications. Those who used the RT-CGM for ≥48 days (per protocol) reduced their A1C by 1.2% (±1.1%) versus 0.6% (±1.1%) in those who used it <48 days (p = .003). Multiple regression analyses statistically adjusting for baseline A1C, an indicator for usage, and known confounders confirmed the observed differences between treatment groups were robust (p = .009). There was no improvement in weight or blood pressure.

Conclusions:

Real-time continuous glucose monitoring significantly improves A1C compared with SMBG in patients with T2DM not taking prandial insulin. This technology might benefit a wider population of people with diabetes than previously thought.     

Use of a large diabetes electronic medical record system in India: clinical and research applications

Background:

The diabetes electronic medical record (DEMR) has emerged as an effective information management tool with the potential to improve diabetes care and research. This study reports on the usefulness of the DEMR system at Dr. Mohan''s Diabetes Specialities Centre (DMDSC), Chennai, India, for clinical and research purposes.

Methods:

The DEMR, set up in 1996 at DMDSC, connects data of nine centers/clinics in different geographical areas in Southern India. The present data analysis is based on a total of 226,228 patients registered in the DEMR system at DMDSC between the years 1991 and 2010.

Results:

The DEMR included data of 139,906 male and 86,322 female patients, of whom 92.6% had type 2 diabetes mellitus (T2DM), 1.4% had type 1 diabetes mellitus (T1DM), and the rest had other types. Patients with T2DM had higher prevalence rates of neuropathy (33.1% vs 13.0%, p < .001), microalbuminuria (25.5% vs 20.0%, p < .001), coronary artery disease (17.5% vs 9.2%, p < .001) and peripheral vascular disease (3.9% vs 2.8%, p = .017) compared with T1DM patients, while prevalence of diabetic retinopathy was similar (37.9% vs 35.7%, p = .06). Prevalence of microvascular and macrovascular complications of diabetes increased with increasing glycated hemoglobin levels (p for trend < .001) and increasing diabetes duration (p for trend < .001).

Conclusions:

The DEMR helps track diabetes care and is a valuable tool for research.     

Individuals Achieve More Accurate Results with Meters That Are Codeless and Employ Dynamic Electrochemistry

Background

Studies have shown that controlling blood glucose can reduce the onset and progression of the long-term microvascular and neuropathic complications associated with the chronic course of diabetes mellitus. Improved glycemic control can be achieved by frequent testing combined with changes in medication, exercise, and diet. Technological advancements have enabled improvements in analytical accuracy of meters, and this paper explores two such parameters to which that accuracy can be attributed.

Methods

Four blood glucose monitoring systems (with or without dynamic electrochemistry algorithms, codeless or requiring coding prior to testing) were evaluated and compared with respect to their accuracy.

Results

Altogether, 108 blood glucose values were obtained for each system from 54 study participants and compared with the reference values. The analysis depicted in the International Organization for Standardization table format indicates that the devices with dynamic electrochemistry and the codeless feature had the highest proportion of acceptable results overall (System A, 101/103). Results were significant when compared at the 10% bias level with meters that were codeless and utilized static electrochemistry (p = .017) or systems that had static electrochemistry but needed coding (p = .008).

Conclusions

Analytical performance of these blood glucose meters differed significantly depending on their technologic features. Meters that utilized dynamic electrochemistry and did not require coding were more accurate than meters that used static electrochemistry or required coding.     

Methodology for Quantifying Fasting Glucose Homeostasis in Type 2 Diabetes: Observed Variability and Lability

Background:

Increased glycemic variability is associated with an increase risk of adverse clinical outcomes in diabetes. Central to the understanding of diabetes is glucose homeostasis. “Good” homeostasis is equated to low glycemic variability, and “poor” homeostasis is linked to greater glycemic variability. We have, therefore, developed a method with the aim to objectively quantify the domain of glucose–insulin homeostasis. We have termed this method as Observed Variability And Lability (OVAL).

Method:

Blood samples for the measurement of glucose and insulin concentrations were acquired every 2 min for 120 min from 12 patients with type 2 diabetes mellitus [T2DM; median (range) age 35 (25–47) years and duration of diabetes 7 (2–9) years receiving oral hypoglycemic treatment] and 27 controls [aged 38(30–53) years] with an equal split of genders and equal distribution of body mass indexes. The insulin–glucose time variant data form the boundaries of OVAL, defined as the ellipse enclosing the 95% confidence intervals of the insulin and glucose concentrations plotted on an x−y scatter graph and normalized to ensure equal weighting of insulin and glucose.

Results:

Less precise OVAL homeostasis was observed in subjects with T2DM, by a factor of 4, in comparison with controls [OVAL, T2DM 7.8(3.8) versus controls 1.9(1.0); p =.0003]. The assessment remained statistically robust (p <.001) with increased sampling intervals up to 8 min.

Conclusion:

The OVAL model is a robust method for measuring glucose–insulin homeostasis in controls and T2DM subjects (available online at http://www.oval-calc.co.uk). Deranged glucose–insulin homeostasis is the hallmark of diabetes and OVAL has the capacity to quantify in the fasting state.     

Nurse-Led Behavioral Management of Diabetes and Hypertension in Community Practices: A Randomized Trial

Background

Several trials have demonstrated the efficacy of nurse telephone case management for diabetes (DM) and hypertension (HTN) in academic or vertically integrated systems. Little is known about the real-world potency of these interventions.

Objective

To assess the effectiveness of nurse behavioral management of DM and HTN in community practices among patients with both diseases.

Design

The study was designed as a patient-level randomized controlled trial.

Participants

Participants included adult patients with both type 2 DM and HTN who were receiving care at one of nine community fee-for-service practices. Subjects were required to have inadequately controlled DM (hemoglobin A1c [A1c] ≥ 7.5 %) but could have well-controlled HTN.

Interventions

All patients received a call from a nurse experienced in DM and HTN management once every two months over a period of two years, for a total of 12 calls. Intervention patients received tailored DM- and HTN- focused behavioral content; control patients received non-tailored, non-interactive information regarding health issues unrelated to DM and HTN (e.g., skin cancer prevention).

Main Outcomes and Measures

Systolic blood pressure (SBP) and A1c were co-primary outcomes, measured at 6, 12, and 24 months; 24 months was the primary time point.

Results

Three hundred seventy-seven subjects were enrolled; 193 were randomized to intervention, 184 to control. Subjects were 55 % female and 50 % white; the mean baseline A1c was 9.1 % (SD = 1 %) and mean SBP was 142 mmHg (SD = 20). Eighty-two percent of scheduled interviews were conducted; 69 % of intervention patients and 70 % of control patients reached the 24-month time point. Expressing model estimated differences as (intervention – control), at 24 months, intervention patients had similar A1c [diff = 0.1 %, 95 % CI (−0.3, 0.5), p = 0.51] and SBP [diff = −0.9 mmH g, 95% CI (−5.4, 3.5), p = 0.68] values compared to control patients. Likewise, DBP (diff = 0.4 mmHg, p = 0.76), weight (diff = 0.3 kg, p = 0.80), and physical activity levels (diff = 153 MET-min/week, p = 0.41) were similar between control and intervention patients. Results were also similar at the 6- and 12-month time points.

Conclusions

In nine community fee-for-service practices, telephonic nurse case management did not lead to improvement in A1c or SBP. Gains seen in telephonic behavioral self-management interventions in optimal settings may not translate to the wider range of primary care settings.KEY WORDS: Diabetes, Hypertension, Implementation     

Vascular and metabolic effects of adrenaline in adipose tissue in type 2 diabetes

Objective:

The aim was to investigate adipose tissue vascular and metabolic effects of an adrenaline infusion in vivo in subjects with and without type 2 diabetes mellitus (T2DM).

Design:

Clinical intervention study with 1-h intravenous adrenaline infusion.

Subjects:

Eight male overweight T2DM subjects and eight male weight-matched, non-T2DM subjects were studied before, during and after an 1-h intravenous adrenaline infusion. Adipose tissue blood flow (ATBF) was determined by ¹³³Xenon wash-out technique, and microvascular volume in the adipose tissue was studied by contrast-enhanced ultrasound imaging. Adipose tissue fluxes of glycerol, non-esterified fatty acids (NEFA), triacylglycerol and glucose were measured by Fick''s principle after catherisation of a radial artery and a vein draining the abdominal, subcutaneous adipose tissue.

Results:

ATBF increased similarly in both groups during the adrenaline infusion. One hour post adrenaline, ATBF was still increased in overweight T2DM subjects. Adrenaline increased microvascular volume in non-T2DM subjects while this response was impaired in overweight T2DM subjects. Adrenaline-induced increase in lipolysis was similar in both groups, but NEFA output from adipose tissue was delayed in overweight T2DM subjects. Glucose uptake in adipose tissue increased in non-T2DM subjects during adrenaline infusion but was unchanged in overweight T2DM subjects. This results in a delayed excess release of NEFA from the adipose tissue in overweight T2DM subjects after cessation of the adrenaline infusion.

Conclusion:

Capillaries in the adipose tissue are recruited by adrenaline in non-T2DM subjects; however, this response is impaired in overweight T2DM subjects. NEFA, released in adipose tissue during adrenaline stimulation, is insufficiently re-esterified in situ in overweight T2DM subjects, probably owing to increased ATBF after adrenaline infusion and inability to increase adipose tissue glucose uptake.