Excessive daytime sleepiness among rural residents in Saskatchewan

BACKGROUND:

Obstructive sleep apnea (OSA) is a common diagnosis in clinical practice. Excessive daytime sleepiness may be a warning for possible OSA.

OBJECTIVES:

To assess the prevalence of excessive daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS) in a rural community population; potential risk factors for OSA were also assessed.

METHODS:

In 2010, a baseline respiratory health questionnaire within the Saskatchewan Rural Health Study was mailed to 11,982 households in Saskatchewan. A total of 7597 adults within the 4624 (42%) respondent households completed the ESS questionnaire. Participants were categorized according to normal or high (>10) ESS scores. Data obtained included respiratory symptoms, doctor-diagnosed sleep apnea, snoring, hypertension, smoking and demographics. Body mass index was calculated. Multivariable logistic regression analysis examined associations between high ESS scores and possible risk factors. Generalized estimating equations accounted for the two-tiered sampling procedure of the study design.

RESULTS:

The mean age of respondents was 55.0 years and 49.2% were male. The prevalence of ESS>10 and ‘doctor diagnosed’ OSA were 15.9% and 6.0%, respectively. Approximately 23% of respondents reported loud snoring and 30% had a body mass index >30 kg/m². Of those with ‘doctor-diagnosed’ OSA, 37.7% reported ESS>10 (P<0.0001) and 47.7% reported loud snoring (P<0.0001). Risk of having an ESS>10 score increased with age, male sex, obesity, lower socioeconomic status, marriage, loud snoring and doctor-diagnosed sinus trouble.

CONCLUSIONS:

High levels of excessive daytime sleepiness in this particular rural population are common and men >55 years of age are at highest risk. Examination of reasons for residual sleepiness and snoring in persons with and without sleep apnea is warranted.     

Convergence of prevalence rates of diabetes and cardiometabolic risk factors in middle and low income groups in urban India: 10-year follow-up of the Chennai Urban Population Study

Aim

The aim of this study was to look for temporal changes in the prevalence of diabetes and cardiometabolic risk factors in two residential colonies in Chennai.

Methods

Chennai Urban Population Study (CUPS) was carried out between 1996–1998 in Chennai in two residential colonies representing the middle income group (MIG) and lower income group (LIG), respectively. The MIG had twice the prevalence rate of diabetes as the LIG and higher prevalence rates of hypertension, obesity, and dyslipidemia. They were motivated to increase their physical activity, which led to the building of a park. The LIG was given standard lifestyle advice. Follow-up surveys of both colonies were performed after a period of 10 years.

Results

In the MIG, the prevalence of diabetes increased from 12.4 to 15.4% (24% increase), while in the LIG, it increased from 6.5 to 15.3% (135% increase, p < .001). In the LIG, the prevalence rates of central obesity (baseline vs follow-up, male: 30.8 vs 50.9%, p < .001; female: 16.9 vs 49.8%, p < .001), hypertension (8.4 vs 20.1%, p < .001), hypercholesterolemia (14.2 vs. 20.4%, p < .05), and hypertriglyceridemia (8.0 vs 23.5%, p < .001) significantly increased and became similar to that seen in the MIG.

Conclusion

There is a rapid reversal of socioeconomic gradient for diabetes and cardiometabolic risk factors in urban India with a convergence of prevalence rates among people in the MIG and LIG. This could have a serious economic impact on poor people in developing countries such as India.     

Prevalence of high Epworth Sleepiness Scale scores in a rural population

BACKGROUND:

Increased daytime sleepiness is an important symptom of obstructive sleep apnea (OSA). OSA is frequently underdiagnosed, and the Epworth Sleepiness Scale (ESS) can be a useful tool in alerting physicians to a potential problem involving OSA.

OBJECTIVE:

To measure the prevalence and determinants of daytime sleepiness measured using the ESS in a rural community population.

METHODS:

A community survey was conducted to examine the risk factors associated with ESS in a rural population in 154 households comprising 283 adults. Questionnaire information was obtained regarding physical factors, social factors, general medical history, family medical history, ESS score, and self-reported height and weight. Multivariable binary logistic regression analysis based on the generalized estimating equations approach to account for clustering within households was used to predict the relationship between a binary ESS score outcome (normal or abnormal) and a set of explanatory variables.

RESULTS:

The population included 140 men (49.5%) and 143 women (50.5%) with an age range of 18 to 97 years (mean [± SD] 52.0±14.9 years). The data showed that 79.2% of the study participants had an ESS score in the normal range (0 to 10) and 20.8% had an ESS score >10, which is considered to be abnormal or high sleepiness. Multivariable regression analysis revealed that obesity was significantly associated with an abnormal or high sleepiness score on the ESS (OR 3.40 [95% CI 1.31 to 8.80).

CONCLUSION:

High levels of sleepiness in this population were common. Obesity was an important risk factor for high ESS score.     

Serum Total Adiponectin Is Associated with Impaired Glucose Tolerance in Asian Indian Females but Not in Males

Objective

Adiponectin may play a role in the development of type 2 diabetes and cardiovascular disease (CVD). However, little is known about the relationship between adiponectin and impaired glucose tolerance (IGT). We investigated the association between adiponectin and IGT and between adiponectin and cardiovascular risk factors among subjects with IGT.

Research Design and Methods

Subjects with normal glucose tolerance (NGT)(n = 571) and impaired glucose tolerance (n = 167) were recruited from the Chennai Urban Rural Epidemiology Study in south India. Serum total adiponectin levels were measured using a radioimmunoassay (Linco Research, St. Charles, MO). High sensitivity C-reactive protein (hsCRP) was estimated by nephelometry.

Results

In sex-stratified analyses, adiponectin was significantly associated with IGT in females [odds ratio (OR): 0.93, 95% confidence interval (CI): 0.872–0.991, p = 0.026] after controlling for age, waist circumference, blood pressure, alcohol consumption, smoking, lipid profile, and glycemic indices; in males there was no significant association (OR = 0.90, 95% CI: 0.798–1.012, p = 0.078). In prediabetic females, adiponectin was not associated with any CVD risk factors (age, waist circumference, blood pressure, cholesterol, triglyceride, high-density lipoprotein, low-density lipoprotein, fasting glucose, fasting insulin, and insulin resistance level), but was associated negatively with 2-hour postplasma glucose levels (r = –0.243, p < 0.05) and hsCRP (r = –0.219, p < 0.05) after adjusting for demographic and biomedical indices. No associations with CVD risk factors were observed in males with IGT.

Conclusion

Serum total adiponectin levels are associated with IGT, 2-hour postplasma glucose, and hsCRP in Asian Indian females but not in males.     

The use of an online pictorial Epworth Sleepiness Scale in the assessment of age and gender specific differences in excessive daytime sleepiness

Background

Excessive daytime sleepiness (EDS) is a non-specific but highly prevalent cardinal symptom of sleep disorders. We hypothesized that with modern media and an online pictorial Epworth Sleepiness Scale (ESS) age and gender specific differences of EDS could be identified on a large scale. This could be helpful in the screening of patients with sleep disorders.

Patients and methods

In 8,098 subjects, age and gender were recorded in addition to an online pictorial ESS (range 0-24 points). The cut-off for EDS (ESS >10 points) was chosen in line with the traditional ESS.

Results

The prevalence of EDS was slightly higher in male subjects (45% vs. 43%, P=0.033). When age was considered, female subjects tended to be sleepier in their 3^rd and 4^th lifetime decade (P=0.01 and P=0.003, respectively), whilst male subjects scored significantly higher in their 7^th decade (P<0.0001); there was a trend to more daytime symptoms with higher age (P for trend <0.001).

Conclusions

The online pictorial ESS identifies gender differences in EDS and reveals increased levels of sleepiness associated with higher age. The use of modern media facilitates reaching out to the general population to raise awareness of conditions associated with EDS such as sleep apnoea.     

Indian Diabetes Risk Score helps to distinguish type 2 from non-type 2 diabetes mellitus (GDRC-3)

Aim

The aim of this study was to investigate whether the Indian Diabetes Risk Score (IDRS) could assist in classifying type 2 diabetes mellitus (T2DM) and non-T2DM among patients attending clinics in India.

Methods

Patient records from 2006 through 2009 were taken from the clinical database of a tertiary care diabetes hospital in Chennai, Southern India. A total of 8747 patients with diabetes, diagnosed by a physician either as type 1 diabetes mellitus (T1DM), T2DM, or other types were included for analysis. The IDRS, based on age, abdominal obesity, family history of diabetes, and physical activity, was calculated for each patient at first visit to our clinic. Receiver operating characteristic (ROC) curves were generated to obtain optimal IDRS cut points for predicting T2DM and non-T2DM.

Results

Of the 8747 patient records analyzed, 204 (2.3%) were classified as non-T2DM and 8543 (97.7%) as T2DM. In ROC analysis, an IDRS ≥60 [area under the curve (AUC), 0.894; sensitivity, 83.8%; specificity, 81.0%] was predictive of T2DM, while an IDRS <60 (AUC, 0.882; sensitivity, 79.9%; specificity, 83.8%) was predictive of non-T2DM.

Conclusions

The IDRS, a simple, cost-effective risk score, can assist in classifying T2DM versus non-T2DM among clinic patients in India.     

Abdominal adiposity depots are correlates of adverse cardiometabolic risk factors in Caucasian and African-American adults

Objective:

Accumulation of adipose tissue is associated with cardiometabolic risks. Although visceral adipose tissue (VAT) has been strongly implicated in this relationship, there is still some debate regarding the contribution of abdominal subcutaneous adipose tissue (SAT). The purpose of this study was to determine the contribution of abdominal SAT to cardiometabolic risk factors, independent of total and visceral adiposity. These relationships were assessed in Caucasian and African Americans.

Design:

It is a cross-sectional analysis of the Pennington Center Longitudinal Study.

Subjects:

Data were extracted from 1246 participants. Total body fat mass (FM) was measured by dual-energy X-ray absorptiometry, whereas abdominal VAT and SAT areas (cm²) were measured with computed tomography. The cardiometabolic risk factors included resting blood pressure (BP), fasting blood glucose and triglyceride concentrations and high-density lipoprotein cholesterol (HDL-C).

Results:

Positive relationships across tertiles of VAT were seen for the participants with high glucose, high BP and low HDL-C (P<0.043). There was also a significant increase in the percentage of participants with two or more cardiometabolic risk factors across most tertiles of abdominal SAT (P<0.042). Logistic regression analysis showed that in univariate models, all adiposity measures were significantly associated with increased odds of having all risk factors in men and women. In multivariate models, VAT was significantly associated with most risk factors across gender. Abdominal SAT and FM (odds ratios (ORs) 1.3–2.1; all P<0.05) were associated with fewer risk factors after accounting for VAT. VAT (OR=5.9 and 5.3) and SAT (OR=2.0 and 1.8) were both associated with higher odds of the presence of two or more cardiometabolic risk factors in both males and females (P<0.001).

Conclusion:

The data suggest that abdominal SAT is not protective against unfavorable cardiometabolic risk profiles. These conclusions were consistent across ethnic groups.     

Combined Pioglitazone and Metformin Treatment Maintains the Beneficial Effect of Short-Term Insulin Infusion in Patients with Type 2 Diabetes: Results from a Pilot Study

Background

The aim of our study was to examine the efficacy of short-term intravenous insulin intervention followed by oral pioglitazone/metformin therapy to prevent patients from continuous insulin application.

Methods

This prospective, open-label, 4-month pilot study comprised of 14 diabetes patients (5 female, 9 male; age 60 ± 2 years; body mass index 29 ± 3.2 kg/m²; hemoglobin A1c [HbA1c] 7.6 ± 1.1%) with (1) insufficient glycemic control under a dose of metformin ≥1700 mg/day and/or metformin plus additional oral antidiabetes drugs (OADs) and (2) appropriate residual β-cell function. Initially, an inpatient 34 h continuous intravenous insulin infusion was performed, and metformin was given (2x 850 mg/day). Insulin was stopped, and pioglitazone 30 mg/day was added at the second inpatient day. Patients were followed for four months. Efficacy parameters [change of HbA1c, fasting blood glucose [FBG], intact proinsulin, adiponectin, and high-sensitivity C-reactive protein (hsCRP)] were assessed after initial normalization of blood glucose values by intravenous insulin and at the study end point.

Results

During the acute insulin intervention, FBG levels were stabilized in all study subjects. In the following OAD treatment period, five patients showed an improvement of HbA1c > 0.5% [35.7%; seven patients remained stable (50.0%), two patients were nonresponders (14.3%)].Fasting glucose values dropped after insulin infusion (-17.7%; p < .001). This effect was maintained during the consecutive OAD treatment period (glucose +0.3%, not significant (NS); HbA1c -6.0%; p < .05). The initial decrease in fasting intact proinsulin levels was also maintained during the study (end value -41%, p < .05).Improvements in hsCRP values (postinsulin value, -15%, NS; end value -37%; p < .05) and adiponectin values (postinsulin value +15%, NS; end value +128%; p < .001) were demonstrated at end point only after continued glitazone intake.

Conclusions

Our pilot study demonstrated that a beneficial effect of a short-term intravenous insulin application on glycemic control was effectively maintained by pioglitazone/metformin treatment for at least 4 months. In addition, the oral therapy significantly improved cardiovascular risk parameters.     

Impact of a physician-supervised exercise-nutrition program with testosterone substitution in partial androgen-deficient middle-aged obese men

Background Partial androgen deficiency syndrome in the aging male is associated with signs of aging such as a development of abdominal obesity, sexual dysfunction, increase body fat, weight gain and the development of cardiac disease. Objective We assessed the outcome of a commercially available physician supervised nutrition and exercise program with concomitant testosterone replacement therapy in middle age obese men with partial androgen deficiency in order to reduce cardiac risks factors. Methods Fifty-six self referred men without diabetes mellitus, hypertension, or cardiovascular disease (ages 52.3 ± 7.8 years) were randomly selected from a large cohort. Baseline weight, body fat composition, fasting glucose, hemoglobin A1c and fasting lipid levels, as well as free and total testosterone levels were assessed. All patients were assessed and followed 6–18 months after initiation of the program. The program consisted of a low glycemic load balanced nutrition diet, a recommended structured daily exercise program of 30–60 minutes, as well as once to twice weekly intramuscular testosterone injections (113.0 ± 27.8 mg). Results At follow up, weight was reduced from 233.9 ± 30.0 pounds (lbs) to 221.3 ± 25.1 lbs (P < 0.001), BMI was reduced from 33.2 ± 3.3 kg/m² to 31.3 ± 2.8 kg/m² (P < 0.0001). Total body fat was 27.1% ± 5.2% vs. 34.3% ± 5.7% at baseline (P < 0.0001). Fasting glucose was reduced from 95.3 ± 14.4 mg/dL to 87.5 ± 12.6 mg/dL (P < 0.0001). Total cholesterol was reduced from 195.4 ± 33.0 mg/dL to 172.7 ± 35.0 mg/dL (P < 0.005). No clinically significant adverse events were recorded. Conclusions Testosterone replacement therapy in middle aged obese men with partial androgen deficiency appeared safe and might have promoted the effects of a weight reduction diet and daily exercise program as long as an adequate physician supervision and follow up was granted. The combination therapy significantly reduced coronary risk factors such as glucose intolerance and hyperlipidemia.     

Nocturnal pulse rate and symptomatic response in patients with obstructive sleep apnoea treated with continuous positive airway pressure for one year

Background

Obstructive sleep apnoea (OSA) is the most common form of sleep-disordered breathing and a known risk factor for cardiovascular disease. We hypothesised that in patients with OSA the characteristics of nocturnal pulse rate (PR) are associated with changes in blood pressure and daytime sleepiness, following commencement of continuous positive airway pressure (CPAP) therapy.

Methods

Pulse oximetry data, demographics, daytime sleepiness and blood pressure were recorded at baseline and at one year follow up. Patients with OSA were grouped according to positive and negative changes in the PR (ΔPR) response during the first night of pulse oximetry before commencement of CPAP.

Results

A total of 115 patients (58 with OSA and 57 matched subjects without OSA) were identified and included in the analysis. The scale of improvement in daytime sleepiness could be predicted by a negative or positive ΔPR, as recorded in the initial screening pulse oximetry [ΔESS –5.8 (5.1) vs. –0.8 (7.2) points, P<0.05]. A negative correlation was observed between mean nocturnal PR and changes in systolic blood pressure (SBP) after one year of CPAP treatment (r=–0.42, P<0.05).

Conclusions

Mean nocturnal PR prior to CPAP initiation was associated with changes in SBP at one year follow up. A descending nocturnal PR in patients with OSA, prior to CPAP initiation, might help to identify a symptomatic response from long term CPAP treatment.     

Predictability of 1‐h postload plasma glucose concentration: A 10‐year retrospective cohort study

Aims/Introduction

Elevated 1-h postload plasma glucose concentration (1hPG) during oral glucose tolerance test has been linked to an increased risk of type 2 diabetes and a poorer cardiometabolic risk profile. The present study analyzed the predictability and cut-off point of 1hPG in predicting type 2 diabetes in normal glucose regulation (NGR) subjects, and evaluated the long-term prognosis of NGR subjects with elevated 1hPG in glucose metabolism, kidney function, metabolic states and atherosclerosis.

Materials and Methods

A total of 116 Han Chinese classified as NGR in 2002 at the First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China, were investigated. Follow-up was carried out in 2012 to evaluate the progression of glucose metabolism, kidney function, metabolic syndrome and carotid atherosclerosis.

Results

The areas under receiver operating characteristic curves were higher for 1hPG than FPG or 2hPG (0.858 vs 0.806 vs 0.746). The cut-off value of 1hPG with the maximal sum of sensitivity and specificity in predicting type 2 diabetes in NGR subjects was 8.85 mmol/L. The accumulative incidence of type 2 diabetes in subjects with 1hPG ≥8.85 mmol/L was higher than those <8.85 mmol/L (46.2% vs 3.3%, P = 0.000; relative risk 13.846, 95% confidence interval 4.223–45.400). On follow up, the prevalence of metabolic syndrome and abnormal carotid intima-media thickness in the subjects with 1hPG ≥8.85 mmol/L tended to be higher compared with those <8.85 mmol/L.

Conclusions

1hPG is a good predictor of type 2 diabetes in NGR subjects, and the best cut-off point is 8.85 mmol/L. Some tendency indicates that NGR subjects with 1hPG ≥8.85 mmol/L are more prone to metabolic syndrome and carotid atherosclerosis.     

Are late-night eating habits and sleep duration associated with glycemic control in adult type 1 diabetes patients treated with insulin pumps?

Aims/Introduction

Little is known about the impact of sleep duration and late-night snacking on glycemic control in patients with type 1 diabetes using insulin pumps. The aim of the present study was to examine whether late-night eating habits and short sleep duration are associated with glycemic control in continuous subcutaneous insulin infusion-treated type 1 diabetic patients.

Materials and Methods

We included 148 consecutive adult type 1 diabetic subjects using an insulin pump (100 women and 48 men). Participants completed a questionnaire regarding sleep duration (classified as short if ≤6 h) and late-night snacking. Other sources of information included medical records and data from blood glucose meters. Glycemic control was assessed by glycated hemoglobin (HbA1c) levels and mean self-monitoring of blood glucose (SMBG) readings.

Results

The mean age of patients was 26 years, mean type 1 diabetes duration was 13.4 years and mean HbA1c level was 7.2%. In a univariate regression analysis, sleep duration was a predictor of both HbA1c (β = 0.51, P = 0.01) and SMBG levels (β = 11.4, P = 0.02). Additionally, an association was found between frequent late-night snacking and higher SMBG readings (often snacking β = 18.1, P = 0.05), but not with increased HbA1c levels. In the multivariate linear regression, independent predictors for HbA1c and SMBG were sleep duration and patient age. In a univariate logistic regression, sleep duration and frequency of late-night snacking were not predictors of whether HbA1c target levels were achieved.

Conclusions

Short sleep duration, but not late-night snacking, seems to be associated with poorer glycemic control in type 1 diabetic patients treated with continuous subcutaneous insulin infusion.     

Determinants of the accuracy of continuous glucose monitoring in non-critically ill patients with heart failure or severe hyperglycemia

Background

The accuracy of continuous glucose monitoring (CGM) in non-critically ill hospitalized patients with heart failure or severe hyperglycemia (SH) is unknown.

Methods

Hospitalized patients with congestive heart failure (CHF) exacerbation (receiving IV or subcutaneous insulin) or SH requiring insulin infusion were compared to outpatients referred for retrospective CGM.

Results

Forty-three patients with CHF, 15 patients with SH, and 88 outpatients yielded 470, 164, and 2150 meter–sensor pairs, respectively. Admission glucose differed (188 versus 509 mg/dl in CHF and SH, p < .001) but not the first sensor glucose (p = .35). In continuous glucose error grid analysis, 67–78% of pairs during hypoglycemia were in zones A+B (p = .63), compared with 98–100% in euglycemia (p < .001) and 98%, 92%, and 99% (p = .001) during hyperglycemia for the CHF, SH, and outpatient groups, respectively. Mean absolute relative difference (MARD) was lower in the CHF versus the SH group in glucose strata above 100 mg/dl, but there was no difference between the CHF and outpatient groups. Linear regression models showed that CHF versus outpatient, SH versus CHF, and coefficient of variation were significant predictors of higher MARD. Among subjects with CHF, MARD was not associated with brain natriuretic peptide or change in plasma volume, but it was significantly higher in subjects randomized to IV insulin (p = .04).

Conclusions

The results suggest that SH and glycemic variability are more important determinants of CGM accuracy than known CHF status alone in hospitalized patients.     

Effects of a structured self-monitoring of blood glucose method on patient self-management behavior and metabolic outcomes in type 2 diabetes mellitus

Background

The purpose of this study was to evaluate the effect of structured self-monitoring of blood glucose (SMBG) on patient self-management behavior and metabolic outcomes in patients with type 2 diabetes mellitus (T2DM).

Methods

From January to June 2009, 30 patients with basic diabetes education were followed for a period of 90 days. To provide assessment of glycemic control and frequency of dysglycemia, patients, underwent 3 consecutive days of seven-point SMBG during each month for 3 consecutive months, using the ACCU-CHEK 360° View tool. Glucose profiles of the first and third month were used for comparison.

Results

Hemoglobin A1c (HbA1c) improved significantly during the 90-day period in all patients [confidence interval (CI) 95%, 0.32–1.64%, p < .05] and those with poor metabolic control (group B; CI 95%, 0.86–2.64%, p < .05). Mean blood glucose (MBG) values decreased significantly in group B (CI 95%, 0.56–24.78 mg/dl, p < .05) and all cases (CI 95%, 1.61–19.73 mg/dl, p < .05). Meanwhile, there was an average decrease of 15.7 mg/dl in fasting blood sugar (FBS) levels in the whole subjects. Mean postprandial blood glucose levels (MPP) decreased by 19.3 and 11.3 mg/dl in group B and in all cases, respectively. However, there were no significant changes in HbA1c, MBG, FBS, and MPP in people with good metabolic control.

Conclusion

A structured SMBG program improves HbA1c, FBS, MPP, and MBG in people with poorly controlled diabetes. This improvement shows the importance of patient self-management behavior on metabolic outcomes in T2DM.     

Average daily risk range as a measure of glycemic risk is associated with mortality in the intensive care unit: a retrospective study in a burn intensive care unit

Background

Although tight glycemic control has been associated with improved outcomes in the intensive care unit (ICU), glycemic variability may be the influential factor in mortality. The main goal of the study was to relate blood glucose (BG) variability of burn ICU patients to outcomes using a sensitive measure of glycemic variability, the average daily risk range (ADRR).

Method

Data from patients admitted to a burn ICU were used. Patients were matched by total body surface area (TBSA) and injury severity score (ISS) to test whether increased BG variability measured by ADRR was associated with higher mortality risk and whether we could identify ADRR-based classifications associated with the degree of risk.

Results

Four ADRR classifications were identified: low risk, medium-low, medium-high, and high. Mortality progressively increased from 25% in the low-risk group to over 60% in the high-risk group (p < .001). In a post hoc analysis, age also contributed to outcome. Younger (age < 43 years) survivors and nonsurvivors matched by TBSA and ISS had no significant difference in age, mean BG or standard deviation of BG; however, nonsurvivors had higher ADRR (p < .01).

Conclusions

Independent of injury severity, glycemic variability measured by the ADRR was significantly associated with mortality in the ICU. When age was considered, ADRR was the only measure of glycemia significantly associated with mortality in younger patients with burns.     

Postprandial glucose monitoring further improved glycemia, lipids, and weight in persons with type 2 diabetes mellitus who had already reached hemoglobin A1c goal

Background

Postprandial hyperglycemia contributes to poor glucose control and is associated with increased cardiovascular risk in type 2 diabetes mellitus (T2DM). The objective of the study was to determine the effect of postprandial self-monitoring of blood glucose (pp-SMBG) on glucose control, lipids, body weight, and cardiovascular events.

Method

Subjects with T2DM hemoglobin A1c (A1C) between 6.5 to 7.0% were randomized into the study group (at least two pp-SMBG a day and dietary modification based on glucose readings) and control group (dietary modification based on glucose readings but no mandatory pp-SMBG) for a 6-month, observational study. Oral antidiabetic drugs or insulin regimen was unchanged in either group if A1C remained less than 7.0% during the study. End points included A1C, lipids, body weight, and cardiovascular events.

Results

One hundred sixty-nine subjects, mean age 63 years, and body weight 88 kg were recruited. Hemoglobin A1c, weight, low-density lipoprotein (LDL), and triglycerides (TGs) were similar in the groups at baseline. By the end of 6 months, A1C (6.7 ± 0.1 to 6.4 ± 0.1%, p < .05), body weight (88.5 ± 7.3 to 85.2 ± 6.3 kg, p < .05), LDL (92.3 ± 2 8.4 to 81.1 ± 22.6 mg/dl, p < .05), and TGs (141 ± 21 to 96 ± 17 mg/dl, p < .05) decreased in the study group, but did not change in the control group. No cardiovascular events were observed in either group during the 6-month study period.

Conclusions

In T2DM subjects who had already reached their A1C goal, pp-SMBG at least twice a day was associated with further improvement in glycemia, lipids, and weight, as well as exercise and dietary habit. We assume that lifestyle modification promoted by postprandial hyperglycemia awareness may underlie these findings. These results substantiate the importance of implementing pp-SMBG into lifestyle modification, and emphasize that pp-SMBG is critical in the control of T2DM.     

Combined Insulin Pump Therapy with Real-Time Continuous Glucose Monitoring Significantly Improves Glycemic Control Compared to Multiple Daily Injection Therapy in Pump Na?ve Patients with Type 1 Diabetes; Single Center Pilot Study Experience

Objectives

This study assessed the safety and clinical effectiveness of the training protocol for initiating insulin pump therapy with real-time continuous glucose monitoring (MiniMed Paradigm REAL-Time System) in a stepwise approach on pump naive subjects with type 1 diabetes compared to a control group who remained on multiple daily injection (MDI) therapy.

Methods

This was a 15-week treat-to-target pilot study of 16 adult subjects (n = 50% male, age 45.9 ± 16 years) with type 1 diabetes (duration of diabetes 21.9 ± 11 years) on MDI therapy with hemoglobin A1c levels at or above 7.5% at baseline. Subjects were randomized to either the study arm (using a combined insulin pump and real-time continuous glucose monitoring system) or the control arm [which continued on MDI therapy with self-monitored blood glucose (SMBG) only]. All subjects dosed insulin according to results of SMBG by finger stick and uploaded data into the CareLink data management software.

Results

Significant improvements in glycemic control were observed from baseline in both study groups—study arm: pre-A1c 9.45 ± 0.55 and post-A1c 7.4 ± 0.66 (p = 0.00037); control arm: pre-A1c 8.58 ± 1.30 and post-A1c 7.5 ±1.01 (p = 0.04). Both arms had no incidence of severe hypoglycemia.

Conclusion

In this pilot study, the Paradigm REAL-Time System was initiated safely and effectively in type 1 diabetes patients who were pump naïve using a stepwise educational protocol.     

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.     

Concealed Maternal Blood Glucose Excursions Correlate with Birth Weight Centile

Background

The objective of this study was to test the hypothesis that maternal blood glucose excursions correlate with deviation from optimized birth weight.

Methods

Patients were recruited for 3-day continuous glucose monitoring (CGM) plus self-blood glucose monitoring followed by routine diabetes screening at 26-28 weeks gestation. Patients and caregivers were blinded to CGM results. The magnitude and duration of blood glucose (BG) excursions were measured as a “glycemia index.” A customized birth weight centile was calculated.

Results

Twenty-three patients consented, 21 completed the study: 5 diabetic and 16 nondiabetic individuals. The duration of CGM was 72 (±7.2) hours, and each patient performed self-BG monitoring ≥3 times per day. All diabetic and 10 nondiabetic patients had several measured BG excursions above 130 mg/dl. A positive correlation was observed between birth weight centile and glycemia index above 130 (p < 0.03); the trend persisted for nondiabetic patients alone (p < 0.05). No significant correlation was noted between birth weight centile and average 3-day CGM values, 3-day fasting BG, average 3-day self-BG monitoring values, or diabetes screening BG value.

Conclusions

The glycemia index has a better correlation with birth weight centile than BG measured by conventional methods in a mixed diabetic and nondiabetic population. Fetal exposure to maternal blood glucose excursions correlates positively with fetal growth, even in nondiabetic patients with apparently normal glucose tolerance.     

Mobile phone-based video messages for diabetes self-care support

Background

This study examined whether mobile phone-based, one-way video messages about diabetes self-care improve hemoglobin A1c (A1C) and self-monitoring of blood glucose (SMBG).

Methods

This was a 1-year prospective randomized trial with two groups. The active intervention lasted 6 months. The study enrolled 65 people with A1C >8.0% who were established (>6 months) patients in the endocrinology clinics of the Walter Reed Health Care System. Participants were randomized to receive “usual care” or self-care video messages from their diabetes nurse practitioner. Video messages were sent daily to cell phones of study participants. Hemoglobin A1c and SMBG data were collected at 0, 3, 6, 9, and 12 months.

Results

Participants who received the messages had a larger rate of decline in A1C than people who received usual care (0.2% difference over 12 months, adjusting for covariates; p = .002 and p = .004 for the interaction between time and group and for the quadratic effect of time by group, respectively). Hemoglobin A1c decline was greatest among participants who received video messages and viewed >10 a month (0.6% difference over 12 months, adjusting for covariates; p < .001 for the interaction between time and group and the quadratic effect). Self-monitoring of blood glucose metrics were not related to the intervention.

Conclusions

A one-way intervention using mobile phone-based video messages about diabetes self-care can improve A1C. Engagement with the technology is an important predictor of its success. This intervention is simple to implement and sustain.