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Summary Objective The safety and tolerability of three treatments for diabetic peripheral neuropathic pain (DPNP) were compared. Methods A 12‐week, randomized, open‐label study confirming the non‐inferiority of duloxetine (N = 138) vs. pregabalin (N = 134) and the combination of duloxetine plus gabapentin (N = 135) as the primary outcome was previously published. Patients had an inadequate pain response to a stable dose of gabapentin (≥ 900 mg/day) for ≥ 5 weeks prior to study enrolment. Data from that study were assessed in this current analysis for a detailed report of safety and tolerability. Results Completion rates did not differ significantly between the groups. Discontinuation because of adverse events was significantly greater in the duloxetine (19.6%) vs. pregabalin group (10.4%; p = 0.04); no differences emerged between the duloxetine vs. duloxetine plus gabapentin (13.3%) groups (p = 0.19) or pregabalin vs. duloxetine plus gabapentin groups (p = 0.57). Adverse event rates varied: nausea, insomnia, hyperhidrosis and decreased appetite were reported significantly more often in patients treated with duloxetine vs. patients treated with pregabalin (each p ≤ 0.01); insomnia significantly more in patients treated with duloxetine vs. duloxetine plus gabapentin (p = 0.01); peripheral oedema significantly more in patients treated with pregabalin vs. duloxetine and duloxetine plus gabapentin (p ≤ 0.001 each) and nausea, hyperhidrosis, decreased appetite and vomiting significantly more in patients treated with duloxetine plus gabapentin vs. pregabalin (each p ≤ 0.05). At end‐point, weight change differed significantly among treatment groups: patients in the pregabalin group on average gained weight (1.0 ± 0.04 kg); while, patients in the duloxetine and duloxetine plus gabapentin groups on average lost weight (−2.39 ± 0.04 and −1.06 ± 0.04 kg, respectively) (pregabalin vs. duloxetine, p ≤ 0.001; pregabalin vs. duloxetine plus gabapentin, p ≤ 0.001; duloxetine vs. duloxetine plus gabapentin, p = 0.01). Conclusion Duloxetine, pregabalin and duloxetine plus gabapentin were generally safe and tolerable for the treatment of DPNP.

To determine whether duloxetine is noninferior to (as good as) pregabalin in the treatment of pain associated with diabetic peripheral neuropathy. We performed a 12-week, open-label study of patients with diabetic peripheral neuropathic pain who had been treated with gabapentin (≥900 mg/d) and had an inadequate response (defined as a daily pain score of ≥4 on a numerical rating scale [0-10 points]). The first patient was enrolled on September 28, 2006, and the last patient visit occurred on August 26, 2009. Patients were randomized to duloxetine monotherapy (n=138), pregabalin monotherapy (n=134), or a combination of duloxetine and gabapentin (n=135). The primary objective was a noninferiority comparison between duloxetine and pregabalin on improvement in the weekly mean of the diary-based daily pain score (0- to 10-point scale) at end point. Noninferiority would be declared if the mean improvement for duloxetine was no worse than the mean improvement for pregabalin, within statistical variability, by a margin of –0.8 unit. The mean change in the pain rating at end point was –2.6 for duloxetine and –2.1 for pregabalin. The 97.5% lower confidence limit was a –0.05 difference in means, establishing noninferiority. As to adverse effects, nausea, insomnia, hyperhidrosis, and decreased appetite were more frequent with duloxetine than pregabalin; insomnia, more frequent with duloxetine than duloxetine plus gabapentin; peripheral edema, more frequent with pregabalin than with duloxetine; and nausea, hyperhidrosis, decreased appetite, and vomiting, more frequent with duloxetine plus gabapentin than with pregabalin. Duloxetine was noninferior to pregabalin for the treatment of pain in patients with diabetic peripheral neuropathy who had an inadequate pain response to gabapentin. Trial Registration: clinicaltrials.gov Identifier: NCT00385671

The diabetes pandemic has outpaced the US supply of diabetes specialists and has overwhelmed primary care providers (physicians, physician assistants, and nurse practitioners). Primary care diabetes fellowships can be used to address this workforce shortage.To determine the skills obtained during 2 diabetes fellowship programs, the barriers encountered in practice, the impact of the programs on career paths, and perceived acceptance by patients and colleagues.A Qualtrics link to a 26-item survey was sent via email to all graduates of the Ohio University Heritage College of Osteopathic Medicine and East Carolina University Brody School of Medicine diabetes fellowship programs. Items included demographic information, comfort level with different clinical diabetes skills, and current system barriers encountered in their practices.Of 39 graduates, 36 completed the survey. The most beneficial skills acquired during the fellowship were insulin pump management (13 [36%]), insulin management (10 [29%]), and diabetes pharmacology (6 [17%]). The most common barrier was the lack of board certification as a diabetologist, which affected time with patients and insurance reimbursement. The perceived acceptance by patients was high (25 [69%]), and the perceived receptiveness by colleagues was mostly neutral (7 [19%]) or positive (10 [29%]). The most common postfellowship career path was primary care medicine (15) followed by hospitalist (7) and diabetologist (5).Physicians who completed the diabetes fellowship training reported high comfort levels with treating patients with diabetes, but they also reported the barriers faced in an unrecognized specialty.

To determine whether 1 or 2 preprandial injections before the meals of greatest glycemic impact can be as effective as 3 preprandial injections in patients with type 2 diabetes mellitus and basal insulin treatment failure. This was an open-label, parallel-group, 1:1:1 randomized study of adults with type 2 diabetes mellitus on oral antidiabetic drugs with glycated hemoglobin (A1C) levels of 8.0% or greater. After a 14-week run-in with insulin glargine, patients with an A1C level greater than 7.0% were randomly assigned to 1, 2, or 3 time(s) daily insulin glulisine for 24 weeks. Changes in A1C from randomization to study end; percentage of patients achieving an A1C level less than 7.0%; changes in A1C, fasting glucose concentrations, and weight at individual study points; and safety (adverse events and hypoglycemia) were assessed throughout the study. Three hundred forty-three of 631 patients (54%) completing the run-in phase with insulin glargine were randomly assigned to treatment arms. During the randomization phase, A1C reductions with insulin glulisine once or twice daily were noninferior to insulin glulisine 3 times daily (confidence intervals: -0.39 to 0.36 and -0.30 to 0.43; P>.5 for both). However, more patients met the target A1C with 3 preprandial injections (46 [46%]) than with 2 injections (34 [33%]) or 1 injection (30 [30%]). Severe hypoglycemia occurred in twice as many patients receiving 3 preprandial injections (16%) compared with those receiving 2 injections (8%) and 1 injection (7%), but these differences did not reach significance. This study provides evidence that initiation of prandial insulin in a simplified stepwise approach is an effective alternative to the current routine 3 preprandial injection basal-bolus approach.

The purpose of this analysis was to identify patient behaviors that led to optimum glycemic outcomes in subjects with type 1 diabetes (T1DM) who transitioned from multiple daily injections (MDI) therapy to sensor-augmented pump (SAP) therapy. Sensor-augmented pump Therapy for A1C Reduction (STAR 3), a randomized controlled trial, assigned 485 suboptimally controlled T1DM subjects to either MDI therapy (n = 241) or SAP therapy (n = 244). We categorized subjects in the latter group according to age at enrollment and glycated hemoglobin (A1C) value after using the SAP system for 12 months. Pairwise comparisons of how the pump features were used between SAP subjects with the highest and lowest end-of-study A1C values were made via t tests. Larger decreases in A1C values were significantly correlated with increasing sensor use in both the adult and pediatric age groups. Subjects in the low-A1C cohorts of both pediatric and adult age groups gave themselves smaller and more frequent boluses and used the Bolus Wizard bolus estimation calculator more frequently than subjects in age-matched high-A1C cohorts. Children in the low-A1C cohort used less insulin than children in the high-A1C cohort. There was no additional hypoglycemia in either the adult or pediatric low-A1C cohorts versus their high-A1C counterparts. Both adult and pediatric patients with T1DM on SAP who use CGM sensors more often will have a greater decrease in their A1C values than those who do not demonstrate these behaviors. Routine use of CGM may lead to smaller and more frequent bolus dosing, enabling this population to safely reach their A1C goals.

Roux-en-Y gastric bypass surgery (RYGB) reverses type 2 diabetes (DM2) in approximately 83% of patients with morbid or severe obesity. This procedure has been performed in small numbers of severely obese patients with type 1 diabetes (DM1), but the impact on glycemic control and insulin requirement in this population has not been widely described. We report three patients with DM1 and severe obesity that underwent RYGB. Weight, glycemic control, and insulin requirements before and one year after the procedure were compared. Significant weight loss was achieved by all three patients but insulin requirements decreased in only 2 patients. In contrast, glycemic control (A1C) remained suboptimal in all three patients up to one year after the surgery. These findings suggest that RYGB leads to important weight loss and positively affects insulin sensitivity. However, reaching optimal glycemic control in patients with DM1 diabetes remains challenging due to persisting insulin deficiency.

SUMMARY Prospective intervention trials using an intensive therapy approach in patients with either type 1 or type 2 diabetes have provided evidence that achieving tight glycemic control can impede the development and progression of microvascular complications. Treatment of type 2 diabetic patients has revolved around the use of oral agents to improve insulin secretion or tissue sensitization. As therapy turns to the inclusion of insulin - most often in combination with oral agents - the physician and patient must both be prepared for the issues regarding management of an injectable agent. The objective of this article is to review current evidence supporting the benefits of adding insulin therapy to existing oral hypoglycemic regimens of patients for whom these therapies are no longer providing adequate glycemic control. Approaches to initiating insulin therapy and adjusting treatment regimens are discussed, with a view towards making the addition or switch to insulin a simple and achievable next step in treatment.

Background Oral meal consumption increases glucagon-like peptide 1 (GLP-1) release which maintains euglycemia by increasing insulin secretion. This effect is exaggerated during short-term follow-up of Roux-en-y gastric bypass (RYGB). We examined the durability of this effect in patient with type 2 diabetes (T2DM) >10 years after RYGB. Methods GLP-1 response to a mixed meal in the 10-year post-RYGB group ( n  = 5) was compared to lean ( n  = 9), obese ( n  = 6), and type 2 diabetic ( n  = 10) controls using a cross-sectional study design. Analysis of variance (ANOVA) was used to evaluate GLP-1 response to mixed meal consumption from 0 to 300 min, 0–20 min, 20–60 min, and 60–300 min, respectively. Weight, insulin resistance, and T2DM were also assessed. Results GLP-1 response 0–300 min in the 10-year post-RYGB showed a statistically significant overall difference ( p  = 0.01) compared to controls. Furthermore, GLP-1 response 0–20 min in the 10-year post-RYGB group showed a very rapid statistically significant rise ( p  = 0.035) to a peak of 40 pM. GLP-1 response between 20 and 60 min showed a rapid statistically significant ( p  = 0.041) decline in GLP-1 response from ~40 pM to 10 pM. GLP-1 response in the 10-year post-RYGB group from 60 to 300 min showed no statistically significant difference from controls. BMI, HOMA, and fasting serum glucose before and >10 years after RYGB changed from 59.9 → 40.4, 8.7 → 0.88, and 155.2 → 87.6 mg/dl, respectively, and were statistically significant ( p  < 0.05). Conclusions An exaggerated GLP-1 response was noted 10 years after RYGB, strongly suggesting a durability of this effect. This phenomenon may play a key role in maintaining type 2 diabetes remission and weight loss after RYGB.

To show improved glycemic control in patients with insulin-treated diabetes after adjustments to the diabetes management plan based on either continuous glucose monitoring using the Continuous Glucose Monitoring System (CGMS) or frequent self-monitoring of blood glucose (SMBG) using a home blood glucose meter. From January to September 2000, patients aged 19 to 76 years with insulin-treated diabetes were assigned to insulin therapy adjustments based on either CGMS or SMBG values. At the end of the study, patients in both groups used the CGMS for 3 days; these values were used to calculate measures of hypoglycemia. Repeated-measures analysis of variance with post hoc comparisons were used to test differences in hemoglobin A 1c levels and hypoglycemia between the 2 study groups. A total of 128 patients were enrolled in the study. Nineteen discontinued study participation, leaving 51 in the CGMS group and 58 in the SMBG group. No significant differences were noted in demographics or baseline characteristics between the 2 groups. There were no significant differences in hemoglobin A 1c levels between the CGMS group and the SMBG group at baseline (9.1%±1.1% vs 9.0%±1.0%, P=.70), and both groups showed statistically significant ( P>.001) and similar ( P=.95) improvement in hemoglobin A 1c levels after 12 weeks of study. However, the CGMS group had a significantly shorter duration of hypoglycemia (sensor glucose, ≤60 mg/dL) at week 12 of the study (49.4±40.8 vs 81.0±61.1 minutes per event, P=.009). Use of the CGMS to guide therapy adjustments in patients with insulin-treated diabetes reduces the duration of hypoglycemia compared with therapy adjustments guided by SMBG values alone.

Purpose of Review Diabetes is a complex and costly chronic disease that is growing at an alarming rate. In the USA, we have a shortage of physicians who are experts in the care of patients with diabetes, traditionally endocrinologists. Therefore, the majority of patients with diabetes are managed by primary care physicians. With the rapid evolution in new diabetes medications and technologies, primary care physicians would benefit from additional focused and intensive training to manage the many aspects of this disease. Diabetes fellowships designed specifically for primary care physicians is one solution to rapidly expand a well-trained workforce in the management of patients with diabetes. Recent Findings There are currently two successful diabetes fellowship programs that meet this need for creating more expert diabetes clinicians and researchers outside of traditional endocrinology fellowships. We review the structure of these programs including funding and curriculum as well as the outcomes of the graduates. Summary The growth of the diabetes epidemic has outpaced current resources for readily accessible expert diabetes clinical care. Diabetes fellowships aimed for primary care physicians are a successful strategy to train diabetes-focused physicians. Expansion of these programs should be encouraged and support to grow the cadre of clinicians with expertise in diabetes care and improve patient access and outcomes.