Aerobic Fitness and Glycemic Variability in Adolescents with Type 1 Diabetes

ObjectiveThis study examines the association of fitness on glycemic variability (GV) in adolescents with type 1 diabetes mellitus (T1DM). GV has been associated with high frequency of hyper-and hypoglycemia.MethodsNineteen adolescents with T1DM, ages 14 to 19 years, underwent aerobic fitness testing to determine their maximal aerobic capacity (VO₂ max). A continuous glucose monitoring (CGM) device was placed on each subject and worn for 3 to 5 days until a return visit when the subjects underwent a 1-hour treadmill exercise session. Mean amplitude of glycemic excursion (MAGE) was calculated from the CGM data collected between the 2 study visits. Metabolic equivalent (MET), a measure of accumulated metabolic workload during the exercise session, was also calculated.ResultsMean VO₂ max was 46.6 ± 6.8 mL/kg/min, with a range of 34.8 to 57.0 mL/kg/min. Mean MET during the exercise session was 577.2 ± 102.4 and ranged from 354.3 to 716.2 METs. There was an inverse association between VO₂ max and MAGE (r = − 0.46; 95% confidence interval [CI], − 0.01 to − 0.76; P = .048). MET load and MAGE also had an inverse relationship (r = − 0.48; 95% CI, − 0.03 to − 0.77; P = .037).ConclusionGV is inversely associated with fitness and MET load. Aerobic fitness should be promoted in adolescents with T1DM not only because of its multiple beneficial effects but also due to a possible association with GV, leading to fewer extremes in hypo-and hyperglycemia. (Endocr Pract. 2014;20:566-570)     

Relationship of Serum γ‐Glutamyltransferase to Atherogenic Dyslipidemia and Glycemic Control in Type 2 Diabetes

We evaluated possible interactions between BMI and serum γ‐glutamyltransferase (GGT) concentration and their effects on the prevalence of poor glycemic control and common comorbidities of diabetes. We assessed whether the association of BMI with poor glycemic control, hypertension, atherogenic dyslipidemia (i.e., high triglycerides and/or low high‐density lipoprotein (HDL) cholesterol), hypercholesterolemia, and hyperuricemia differed according to serum GGT concentration in a cohort of 3,633 type 2 diabetic individuals. The associations of BMI with different outcome measures were significant, but the associations varied remarkably by GGT concentration. As GGT concentration increased, the association of BMI with atherogenic dyslipidemia and glycemic control strengthened (P = 0.01 and 0.004 for interactions, respectively); in contrast, the association of BMI with hypertension, hypercholesterolemia, and hyperuricemia did not change substantially across GGT quartiles. For example, within the lowest GGT quartile, BMI was not associated with atherogenic dyslipidemia or poor glycemic control, whereas in the highest GGT quartile, the prevalence rates ranged from 62.3 to 74.7% for dyslipidemia and from 75.3 to 83% for poor glycemic control. The results remained unchanged after adjustment for sex, age, alcohol consumption, diabetes duration, and diabetes treatment. In conclusion, our findings show that BMI was associated with atherogenic dyslipidemia and poor glycemic control only when serum GGT activity was in its high‐normal range. These findings suggest that obesity itself may not be a sufficient risk factor for atherogenic dyslipidemia or poor glycemic control in people with type 2 diabetes.     

Quality of Clinical Practice Guidelines for Glycemic Control in Type 2 Diabetes Mellitus

Background

Several studies have reported that clinical practice guidelines (CPGs) in a variety of clinical areas are of modest or variable quality. The objective of this study was to evaluate the quality of an international cohort of CPGs that provide recommendations on pharmaceutical management of glycemic control in patients with type 2 diabetes mellitus (DM2).

Methods and Findings

We searched the National Guideline Clearinghouse (NGC) on February 15th and June 4th, 2012 for CPGs meeting inclusion criteria. Two independent assessors rated the quality of each CPG using the Appraisal of Guidelines for Research & Evaluation II (AGREE II) instrument. Twenty-four guidelines were evaluated, and most had high scores for clarity and presentation. However, scope and purpose, stakeholder involvement, rigor of development, and applicability domains varied considerably. The majority of guidelines scored low on editorial independence, and only seven CPGs were based on an underlying systematic review of the evidence.

Conclusions

The overall quality of CPGs for glycemic control in DM2 is moderate, but there is substantial variability among quality domains within and across guidelines. Guideline users need to be aware of this variability and carefully appraise and select the guidelines that they apply to patient care.     

Supported Telemonitoring and Glycemic Control in People with Type 2 Diabetes: The Telescot Diabetes Pragmatic Multicenter Randomized Controlled Trial

BackgroundSelf-monitoring of blood glucose among people with type 2 diabetes not treated with insulin does not appear to be effective in improving glycemic control. We investigated whether health professional review of telemetrically transmitted self-monitored glucose results in improved glycemic control in people with poorly controlled type 2 diabetes.ConclusionsSupported telemonitoring resulted in clinically important improvements in control of glycaemia in patients with type 2 diabetes in family practice. Current Controlled Trials, registration number ISRCTN71674628.

Trial Registration

Current Controlled Trials ISRCTN 71674628     

Association between Responsible Pet Ownership and Glycemic Control in Youths with Type 1 Diabetes

Type 1 diabetes mellitus (T1DM) a chronic characterized by an absolute insulin deficiency requires conscientious patient self-management to maintain glucose control within a normal range. Family cohesion and adaptability, positive coping strategies, social support and adequate self-regulatory behavior are found to favorably influence glycemic control. Our hypothesis was that the responsible care of a companion animal is associated with these positive attributes and correlated with the successful management of a chronic illness such as type 1 diabetes. We recruited 223 youths between 9 and 19 years of age from the Pediatric Diabetes clinic at the University of Massachusetts Medical School, reviewed the status of their glycemic control (using three consecutive A1c values) and asked them questions about the presence of a pet at home, and their level of involvement with its care. Multivariate analyses show that children who care actively for one or more pets at home are 2.5 times more likely to have control over their glycemic levels than children who do not care for a pet, adjusting for duration of disease, socio-economic status, age and self-management [1.1 to 5.8], p_Wald = 0.032. A separate model involving the care of a petdog only yielded comparable results (OR_a = 2.6 [1.1 to 5.9], p_Wald = 0.023).     

The Relationship Between Breakfast Skipping,Chronotype, and Glycemic Control in Type 2 Diabetes

Breakfast skipping is associated with obesity and an increased risk of type 2 diabetes. Later chronotypes, individuals who have a preference for later bed and wake times, often skip breakfast. The aim of the study was to explore the relationships among breakfast skipping, chronotype, and glycemic control in type 2 diabetes patients. We collected sleep timing and 24-h dietary recall from 194 non-shift-working type 2 diabetes patients who were being followed in outpatient clinics. Mid-sleep time on free days (MSF) was used as an indicator of chronotype. Hemoglobin A1C (HbA_1C) values were obtained from medical records. Hierarchical linear regression analyses controlling for demographic, sleep, and dietary variables were computed to determine whether breakfast skipping was associated with HbA_1C. Additional regression analyses were performed to test if this association was mediated by chronotype. There were 22 participants (11.3%) who self-reported missing breakfast. Breakfast skippers had significantly higher HbA_1C levels, higher body mass indices (BMI), and later MSF than breakfast eaters. Breakfast skipping was significantly associated with higher HbA_1C values (B?=?0.108, p?=?0.01), even after adjusting for age, sex, race, BMI, number of diabetes complications, insulin use, depressive symptoms, perceived sleep debt, and percentage of daily caloric intake at dinner. The relationship between breakfast skipping and HbA_1C was partially mediated by chronotype. In summary, breakfast skipping is associated with a later chronotype. Later chronotype and breakfast skipping both contribute to poorer glycemic control, as indicated by higher HbA_1C levels. Future studies are needed to confirm these findings and determine whether behavioral interventions targeting breakfast eating or sleep timing may improve glycemic control in patients with type 2 diabetes.     

一项住院2型糖尿病患者血糖控制、自我管理行为及心理评估的调查

目的:目前针对中国糖尿病教育管理现状的高质量调查仍然不是很多,因此我们对一家糖尿病专科医院的住院2型糖尿患者进行了问卷调查,收集其自我管理行为、血糖控制及抑郁与心理状况,以探讨糖尿病教育管理工作的重点。方法:对2014年9月至12月间在太原糖尿病专科医院住院治疗的2型糖尿病患者,进行面对面的问卷调查。调查问卷包括一般资料问卷、Toobert行为量表简化版及WHO-5幸福感指数量表(WHO-5Well-Being Index)和中文版简化糖尿病问题量表(short-form Chinese-version PAID[SFPAID-C]scale)。结果:共调查患者330例,经双份录入和数据澄清之后剩余有效问卷315份(95.5%),男性150(47.6%)例,女性165(52.4%)例。患者年龄(60.5±9.2)岁,病程(10.0±7.1)年,BMI(25.3±3.5)kg/m~2、腰围(91.4±9.9)厘米,糖化血红蛋白(Hb A1c)(8.5±2.0)%,超重与肥胖的患者分别为71.8%和88.5%,男性和女性腹型肥胖的患病率分别为75.0%和72.7%,8.6%的患者存在亚临床或临床抑郁问题(SF-PAID-C评分≥15)。73.3%的患者接受过糖尿病教育,86.0%的患者定期监测血糖,过去一年检测过Hb A1c和血脂的患者分别为66.7%、62.9%,87.3%的患者在诊断糖尿病后改变了饮食习惯,61.9%的患者定时定量进餐,74.6%的患者规律运动,66.7%的患者每周运动时间≥150分钟。Toobert行为量表显示,患者在执行每天吃五份以上的水果和蔬菜(2.5±2.5)、把碳水化合物均匀分布到一整天(3.5±2.8)、血糖监测(3.4±2.5)以及检查脚和鞋子(3.7±2.5)方面的天数较少,执行天数为0天的患者比例分别为36.0%、25.8%、13.3%和16.5%。将患者分为接受过(231例,75.2%)和未接受过糖尿病教育(76例,24.8%)两组,接受过糖尿病教育者,年龄更大,病程更长,合并糖尿病视网膜病变、神经病变的百分比及胰岛素治疗的百分比更高,自我管理行为更好,Hb A1c水平更低,但SF-PAID-C评分和WHO-5评分没有显著性差异。将患者根据病程分为5年、6-10年、11-15年、≥16年四组,随着病程增加,接受过糖尿病教育的患者比例增加,糖尿病并发症的患病率及胰岛素治疗的百分比显著增加,WHO-5评分下降,SF-PAID-C评分上升,自我管理行为和Hb A1c差异不显著。回归分析显示,影响Hb A1c的因素包括治疗方案和自我管理行为,影响SF-PAID-C评分的因素包括运动状况及是否合并糖尿病神经病变,影响WHO-5评分的因素包括病程和自我管理行为。结论:饮食、血糖监测、足部护理、社会支持及用药依从性方面的糖尿病教育指导需要更为细致。糖尿病人在病程较长、合并有并发症及使用胰岛素治疗时,才有更大机会获得糖尿病教育,但将错过教育的最佳时机,糖尿病教育的开始时间需更早。在提升幸福指数、改善抑郁和焦虑方面,糖尿病教育没有直接作用,改善疾病控制、坚持自我管理行为、推迟并发症的发生发展,有直接作用。     

Factors Associated with Glycemic Control in Patients with Type 2 Diabetes Mellitus in Rural Areas of the United States

Background: According to the US Department of Health and Human Services, an estimated 18.2 million Americans, or 6.3% of the population, has diabetes mellitus (DM). Approximately 90% of these individuals have type 2 DM. The most widely used clinical test for defining glycemic control is measurement of blood glycosylated hemoglobin (AIC).Objective: The goal of this study was to estimate the proportion of diabetic patients who achieved the AIC goal of _<7.0% in a rural western Pennsylvania practice and to determine the factors that influence the achievement of the AIC goal.Methods: This was an observational study conducted in a rural family medicine office in Clarksburg, Pennsylvania. To be included in the study, patients had to have been diagnosed with type 2 DM >2 years prior, had to be aged >18 years, and had to be adhering to a medical nutrition therapy diet. Both univariate analysis and logistic regressions were used to identify the factors that were associated with the outcome.Results: A total of 136 diabetic patients were included in the study (70 men, 66 women; mean [SD] age, 59.7 [15.2] years). AIC of <7.0% was attained in 75.0% (n = 102) of the patients. Although the majority of patients were obese (69.1% [n = 94] with a body mass index >30 kg/m2), weight was not a factor in reaching AIC goal. The data showed that those patients who were older (62.3 vs 51.9 years; P = 0.004), using oral antidiabetic medication (96.1% vs 87.9%; P = 0.100), and not using insulin (86.3% vs 69.7%; P = 0.030) were more likely to achieve AIC goal. The proportion of patients achieving AIC goal levels decreased as the number of oral medications used increased.Conclusions: In this rural area of western Pennsylvania, the majority of our type 2 DM patients achieved glycemic control (ie, AIC <7.0%). The primary care physician, along with a DM care team, should address the issues of diet, exercise, weight management, and other comorbid illnesses to properly manage patients with type 2 DM. (Insulin. 2007;2:134-141)     

Determinants of the Changes in Glycemic Control with Exercise Training in Type 2 Diabetes: A Randomized Trial

Aims

To assess the determinants of exercise training-induced improvements in glucose control (HbA_1C) including changes in serum total adiponectin and FFA concentrations, and skeletal muscle peroxisome proliferator-activated receptor-γ coactivator-1α (PGC-1α) protein content.

Methods

A sub-cohort (n = 35; 48% men; 74% Caucasian) from the HART-D study undertaking muscle biopsies before and after 9 months of aerobic (AT), resistance (RT), or combination training (ATRT).

Results

Changes in HbA_1C were associated with changes in adiponectin (r = −0.45, P = 0.007). Participants diagnosed with type 2 diabetes for a longer duration had the largest increase in PGC-1α (r = 0.44, P = 0.008). Statistical modeling examining changes in HbA_1C suggested that male sex (P = 0.05), non-Caucasian ethnicity (P = 0.02), duration of type 2 diabetes (r = 0.40; P<0.002) and changes in FFA (r = 0.36; P<0.004), adiponectin (r = −0.26; P<0.03), and PGC-1α (r = −0.28; P = 0.02) explain ∼65% of the variability in the changes in HbA_1C.

Conclusions

Decreases in HbA_1C after 9 months of exercise were associated with shorter duration of diabetes, lowering of serum FFA concentrations, increasing serum adiponectin concentrations and increasing skeletal muscle PGC-1α protein expression.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00458133","term_id":"NCT00458133"}}NCT00458133     

Diabetic Ketoacidosis in Peruvian Patients with Type 2 Diabetes Mellitus

ObjectiveTo describe the clinical and laboratory characteristics of diabetic ketoacidosis (DKA) in adult Peruvian patients with type 2 diabetes mellitus.MethodsIn this cross-sectional analysis, we reviewed clinical charts of type 2 diabetic patients with DKA admitted to Cayetano Heredia Hospital between 2001 and 2005 for data on demographics, previous treatment, previous hospital admissions for DKA, family history of diabetes, precipitating factors, hospital course, mortality, and insulin use 3 and 6 months after the index DKA episode. Patients older than 18 years who had confirmed DKA were included. Patients with type 1 diabetes mellitus were excluded.ResultsWe report on 53 patients with DKA for whom complete clinical and laboratory data were available. Of the 53 patients, 39 (74%) were men; mean age (± SD) was 45 ± 12 years; and 22 (42%) had no previous diagnosis of type 2 diabetes. The following mean (± SD) laboratory values were obtained at DKA diagnosis: glucose, 457 ± 170 mg/dL; pH, 7.15 ± 0.14; bicarbonate, 7.73 ± 6 mEq/L; and anion gap, 24.45 ± 7.44 mEq/L. Of the 53 DKA episodes, 35 (66%) were severe (arterial pH < 7.0 and/or serum bicarbonate < 10 mEq/L). The following precipitating factors were discerned: discontinuation of treatment in 21 (40%), infections in 16 (30%), intercurrent illness in 3 (6%), and no identifiable cause in 13 (25%). Mortality rate was 0%. Three and 6 months after the index DKA episode, insulin was used by 65% and 56% of patients, respectively.ConclusionIn countries with a low incidence of type 1 diabetes, DKA is frequently reported in patients with type 2 diabetes. In this study, 42% of patients had new-onset disease. Most DKA episodes were severe and were related to infection or noncompliance with treatment. (Endocr Pract. 2008;14:442-446)     

Chronic Kidney Disease and Diabetic Retinopathy in Patients with Type 2 Diabetes

Purpose

To explore the relationship between chronic kidney disease (CKD) and diabetic retinopathy (DR) in a representative population of type 2 diabetes mellitus (DM2) patients in Catalonia (Spain).

Methods

This was a population-based, cross-sectional study. A total of 28,344 patients diagnosed with DM2 who had recorded ophthalmologic and renal functional examinations were evaluated. Data were obtained from a primary healthcare electronic database of medical records. CKD was defined as an estimated glomerular filtration ratio (eGFR) of <60 ml/min/1.73m² and/or urine albumin to creatinine ratio (UACR) ≥30 mg/g. DR was categorized as non-vision threatening diabetic retinopathy and vision threatening diabetic retinopathy.

Results

CKD was associated with a higher rate of DR [OR], 95% confidence interval [CI], 1.5 (1.4–1.7). When we analyzed the association between different levels of UACR and DR prevalence observed that DR prevalence rose with the increase of UACR levels, and this association was significant from UACR values ≥10 mg/g, and increased considerably with UACR values ≥300mg/g (Odds ratio [OR], 95% confidence interval [CI], 2.0 (1.6–2.5). This association was lower in patients with eGFR levels 44 to 30 mL/min/1.73m² [OR], 95% confidence interval [CI], 1.3 (1.1–1.6).

Conclusions

These results show that CKD, high UACR and/or low eGFR, appear to be associated with DR in this DM2 population.     

糖化血清白蛋白检测对2型糖尿病患者短期血糖控制的疗效评价

目的：探讨糖化血清白蛋白（glycate dalbumin, GA）作为反映近期（2 周内）血糖控制总体水平的指标在糖尿病人群中的临床应用价值。方法：选取2010 年6 月-2013 年7 月间深圳市福田区中医院住院的2 型糖尿病（T2DM）患者323 例,测定空腹血糖（FPG）、餐后2 小时血糖（2hPG）、1 日指尖血糖谱均值（MBG）、GA、糖化血红蛋白（HbAlc）等,并对其中92 例住院近2 周的患者分别在入院后6 天及12 天复查上述指标。结果：GA 与HbAlc（r=0.791）,FPG（r=0.541）,2hPG（r=0.456）,MBG（r=0.401）,均呈正相关（P 均〈0.01）;患者入院6 天检测GA 为（27.1± 5.45）％,入院12 天为（22.77± 4.34）％,均显著低于入院第一天的（30.31±6.75）％（P〈0.01）;入院6 天和12 天,患者的GA 较入院时分别下降3.12％和7.54％（P〈0.01）;HbAlC 分别下降0.31％和0.78％,GA下降降幅显著大于HbAlc（P〈0.01）。结论：GA可及时、准确的反映短期（1～2 周）平均血糖的变化情况,并与长期血糖控制的金标准HbAlC 有良好的相关性,是监测糖尿病患者血糖控制的良好指标。     

Impact of Walking on Glycemic Control and Other Cardiovascular Risk Factors in Type 2 Diabetes: A Meta-Analysis

Background

Walking is the most popular and most preferred exercise among type 2 diabetes patients, yet compelling evidence regarding its beneficial effects on cardiovascular risk factors is still lacking. The aim of this meta-analysis of randomized controlled trials (RCTs) was to evaluate the association between walking and glycemic control and other cardiovascular risk factors in type 2 diabetes patients.

Methods

Three databases were searched up to August 2014. English-language RCTs were eligible for inclusion if they had assessed the walking effects (duration ≥8 weeks) on glycemic control or other cardiovascular risk factors among type 2 diabetes patients. Data were pooled using a random-effects model. Subgroup analyses based on supervision status and meta-regression analyses of variables regarding characteristics of participants and walking were performed to investigate their association with glycemic control.

Results

Eighteen studies involving 20 RCTs (866 participants) were included. Walking significantly decreased glycosylated haemoglobin A1c (HbA1c) by 0.50% (95% confidence intervals [CI]: −0.78% to −0.21%). Supervised walking was associated with a pronounced decrease in HbA1c (WMD −0.58%, 95% CI: −0.93% to −0.23%), whereas non-supervised walking was not. Further subgroup analysis suggested non-supervised walking using motivational strategies is also effective in decreasing HbA1c (WMD −0.53%, 95% CI: −1.05% to −0.02%). Effects of covariates on HbA1c change were generally unclear. For other cardiovascular risk factors, walking significantly reduced body mass index (BMI) and lowered diastolic blood pressure (DBP), but non-significantly lowered systolic blood pressure (SBP), or changed high-density or low-density lipoprotein cholesterol levels.

Conclusions

This meta-analysis supports that walking decreases HbA1c among type 2 diabetes patients. Supervision or the use of motivational strategies should be suggested when prescribed walking to ensure optimal glycemic control. Walking also reduces BMI and lowers DBP, however, it remains insufficient regarding the association of walking with lowered SBP or improved lipoprotein profiles.

Trial Registration

PROSPERO CRD42014009515     

Conflicts of Interest among Authors of Clinical Practice Guidelines for Glycemic Control in Type 2 Diabetes Mellitus

Background

Conflict of interest (COI) is an important potential source of bias in the development of clinical practice guidelines (CPGs).

Objectives

To examine rates of disclosure of COI, including financial interests in companies that manufacture drugs that are recommended in CPGs on glycemic control in type 2 diabetes mellitus, and to explore the relationship between recommendations for specific drugs in a guideline and author COI.

Methods

We identified a cohort of relevant guidelines from the National Guideline Clearinghouse (NGC) and abstracted COI disclosures from all guideline authors for this observational, cross-sectional study. We determined which hypoglycemic drugs were recommended in each guideline, and explored the relationship between specific disclosures and whether a drug was recommended.

Results

Among 13 included guidelines, the percentage of authors with one or more financial disclosures varied from 0 to 94% (mean 44.2%), and was particularly high for two US-based guidelines (91% and 94%). Three guidelines disclosed no author financial COI. The percentage of authors with disclosures of financial interests in manufacturers of recommended drugs was also high (mean 30%). On average, 56% of manufacturers of patented drugs recommended in each guideline had one or more authors with a financial interest in their company. We did not find a significant relationship between financial interests and whether a drug was recommended in our sample; US-based guidelines were more likely to make recommendations for a specific drug compared to non-US based guidelines.

Discussion

Authors of this cohort of guidelines have financial interests directly related to the drugs that they are recommending. Although we did not find an association between author COI and drugs recommended in these guidelines and we cannot draw conclusions about the validity of the recommendations, the credibility of many of these guidelines is in doubt.     

Association between Poor Glycemic Control,Impaired Sleep Quality,and Increased Arterial Thickening in Type 2 Diabetic Patients

Objective

Poor sleep quality is an independent predictor of cardiovascular events. However, little is known about the association between glycemic control and objective sleep architecture and its influence on arteriosclerosis in patients with type-2 diabetes mellitus (DM). The present study examined the association of objective sleep architecture with both glycemic control and arteriosclerosis in type-2 DM patients.

Design

Cross-sectional study in vascular laboratory.

Methods

The subjects were 63 type-2 DM inpatients (M/F, 32/31; age, 57.5±13.1) without taking any sleeping promoting drug and chronic kidney disease. We examined objective sleep architecture by single-channel electroencephalography and arteriosclerosis by carotid-artery intima-media thickness (CA-IMT).

Results

HbA1c was associated significantly in a negative manner with REM sleep latency (interval between sleep-onset and the first REM period) (β=-0.280, p=0.033), but not with other measurements of sleep quality. REM sleep latency associated significantly in a positive manner with log delta power (the marker of deep sleep) during that period (β=0.544, p=0.001). In the model including variables univariately correlated with CA-IMT (REM sleep latency, age, DM duration, systolic blood pressure, and HbA1c) as independent variables, REM sleep latency (β=-0.232, p=0.038), but not HbA1c were significantly associated with CA-IMT. When log delta power was included in place of REM sleep latency, log delta power (β=-0.257, p=0.023) emerged as a significant factor associated with CA-IMT.

Conclusions

In type-2 DM patients, poor glycemic control was independently associated with poor quality of sleep as represented by decrease of REM sleep latency which might be responsible for increased CA-IMT, a relevant marker for arterial wall thickening.     

Pramlintide as an Adjunct to Basal Insulin: Effects on Glycemic Control and Weight in Patients with Type 2 Diabetes Mellitus

Background: Pramlintide is a synthetic analogue of the β-cell hormone amylin. When used as an adjunct to mealtime insulin, it reduces postprandial glucose concentrations, glycosylated hemoglobin (AIC) values, and weight. Due to its effects on postprandial glucose, pramlintide may also provide similar benefits when used as an adjunct to basal insulin in the absence of mealtime insulin in patients with type 2 diabetes mellitus (DM).Objective: The current post hoc analyses examined the efficacy and tolerability of pramlintide as an adjunct to basal insulin in a subset of patients with type 2 DM in 2 clinical trials.Methods: Post hoc analyses of 2 subgroups of patients with type 2 DM treated with pramlintide and basal insulin (with or without oral agents) with no mealtime insulin are reported. One subgroup of patents was from a 52-week, randomized, double-blind, placebo-controlled study; a second subgroup of patients was from an uncontrolled, open-label study. Mean (SE) changes from baseline in A1C, postprandial glucose, weight, and insulin dose are reported. Tolerability was also assessed.Results: Baseline characteristics (mean [SD]) of the placebo-controlled study were as follows: pramlintide—n = 18; age, 59 (11) years; A1C, 9.4% (1.3%); weight, 88.4 (16.5) kg; body mass index (BMI), 31.8 (6.1) kg/m²; placebo—n = 11; age, 56 (9) years; A1C, 9.4% (1.6%); weight, 92.0 (13.4) kg; and BMI, 31.2 (5.1) kg/m². Baseline characteristics (mean [SD]) of the patients from the open-label study were as follows: N = 10; age, 60 (12) years; A1C, 8.1% (1.3%); weight, 109.2 (26.6) kg; and BMI, 35.7 (8.1) kg/m². In the placebo-controlled study, pramlintide treatment (120 μg BID) as an adjunct to basal insulin (neutral protamine Hagedorn, lente, or ultralente) resulted in mean (SE) reductions in A1C (pramlintide, -1.16% [0.22%]; placebo, -0.48% [0.18%]; P < 0.05) and weight (pramlintide, -2.3 [1.0] kg; placebo, -0.9 [1.0] kg) compared with placebo. Similarly, in the open-label study, pramlintide treatment (120 μg before major meals) as an adjunct to insulin glargine resulted in mean (SE) reductions from baseline in AIC (-0.81% [0.26%]; 95% CI, -1.40 to -0.22) and weight (-2.8 [1.0] kg; 95% CI, -5.12 to -0.47). In addition, mean postprandial glucose excursions, ascertained by self-monitoring of blood glucose readings, were reduced after each meal. In both subgroups, pramlintide was generally well tolerated, and there were no episodes of severe hypoglycemia.Conclusion: The improvements in glycemic control and weight in these post hoc analyses warrant further clinical investigation into the use of pramlintide as a potential next therapeutic step in patients with type 2 DM treated with basal insulin.     

The Synergy to Enable Glycemic Control Following Emergency Department Discharge Program for Adults with Type 2 Diabetes: Step-Diabetes

Objective: To evaluate a diabetes (DM) care delivery model among hyperglycemic adults with type 2 DM being discharged from the emergency department (ED) to home. The primary hypothesis was that a focused education and medication management intervention would lead to a greater short-term improvement in glycemic control compared to controls.Methods: A 4-week, randomized controlled trial provided antihyperglycemic medications management using an evidence-based algorithm plus survival skills diabetes self-management education (DSME) for ED patients with blood glucose (BG) levels ≥200 mg/dL. The intervention was delivered by endocrinologist-supervised certified diabetes educators. Controls received usual ED care.Results: Among 101 participants (96% Black, 54% female, 62.3% Medicaid and/or Medicare insurance), 77% completed the week 4 visit. Glycated hemoglobin A1C (A1C) went from 11.8 ± 2.4 to 10.5 ± 1.9% (P<.001) and 11.5 ± 2.0 to 11.1 ± 2.1% in the intervention and control groups, respectively (P = .012). At 4 weeks, the difference in A1C reduction between groups was 0.9% (P = .01). Mean BG decreased for both groups (P<.001), with a higher percentage of intervention patients (65%) reaching a BG <180 mg/dL compared to 29% of controls (P = .002). Hypoglycemia rates did not differ by group, and no severe hypoglycemia was reported. Medication adherence (Modified Morisky Score©) improved from low to medium (P<.001) among intervention patients and did not improve among controls.Conclusions: This study provides evidence that a focused diabetes care delivery intervention can be initiated in the ED among adults with type 2 diabetes and hyperglycemia and safely and effectively completed in the ambulatory setting. Improvement in short-term glycemic outcomes and medication adherence were observed.Abbreviations: A1C = glycated hemoglobin A1C BG = blood glucose BMI = body mass index CDE = certified diabetes educator CI = confidence interval DM = diabetes mellitus DSME = diabetes self-management education ED = emergency departmentMMAS-8 = Modified Morisky Medication Scale PCP = primary care provider POC = point of care SQ = subcutaneous     

Periodontal Disease in Type 1 Diabetes Mellitus: Influence of Pubertal Stage and Glycemic Control

ObjectiveThough gingivitis is common in children with type 1 diabetes mellitus (T1DM), the overall periodontal health in T1DM during the pubertal stage is less well-characterized. The study was undertaken to explore the possible influence of puberty and metabolic derangement on periodontal health in T1DM.MethodsIn this cross-sectional study, 110 subjects between 10-18 years with T1DM and 52 healthy siblings of similar age were evaluated for pubertal stage, glycosylated hemoglobin (HbA1c), and periodontal health. Simplified oral hygiene index (OHIS), gingival index (GI), plaque index (PI), bleeding on probing (BOP), and probing depth (PPD) were evaluated at 4 sites per tooth as per 6 Ramfjord index teeth used to assess periodontal disease (PD).ResultsPD not merely gingivitis was significantly higher in T1DM (84/110, 76.36%) than the control group (28/52, 53.8%) (P = .004). Irrespective of pubertal status, children with T1DM had worse GI, PI, BOP, and PPD than nondiabetic subjects, although OHIS was better in diabetes. In both T1DM and nondiabetic subjects, pubertal subjects showed significantly worse OHIS, PPD, BOP, and GI than prepubertal subjects. PD was correlated with pubertal stage, age, and HbA1c, although less strongly with the duration of diabetes. In logistic regression, pubertal stage was a stronger predictor of PD (OR = 14.26) than age (OR = 2.22), and HbA1c (OR = 1.5) rather than the presence of diabetes and its duration.ConclusionsThough pubertal status, age, and poor glycemic control rather than the presence of diabetes and its duration are associated with gingivitis and other forms of PD, puberty had a more profound effect in the pathogenesis of PD in T1DM.