Significant Reduction In Mean HbA1c Research Articles

The Endogenous Inhibitor of CETP, apoC1, Remains Ineffective In Vivo after Correction of Hyperglycemia in People with Type 1 Diabetes.

ApolipoproteinC1 (apoC1) is the main physiological inhibitor of the cholesterol ester transfer protein (CETP). Increased CETP activity is associated with macrovascular complications in patients with type 1 diabetes (T1D). ApoC1 has lost its ability to inhibit CETP in patients with T1D, and in vitro glycation of apoC1 increases CETP activity, suggesting that hyperglycemia could be a factor implicated in the loss of the inhibitory effect of apoC1 on CETP. Thus, we aimed to see whether improvement of glycemic control might restore apoC1 inhibitory effect on CETP. We studied 98 patients with T1D and HbA1c > 9% at baseline and 3 months after improvement of glycemic control by a medical intervention (insulin introduction or changes in multi-injection therapy or pump therapy introduction/therapeutic education for all patients). CETP activity was assessed by a radioactive method and plasma apoC1 levels were measured by ELISA. The different isoforms of apoC1 were determined by mass spectrometry. CETP activity was not significantly modified after improvement of glycemic control, despite a significant reduction in mean HbA1c (8.7 ± 1.7 vs. 10.8 ± 2, p < 0.0001). No association between plasma apoC1 and CETP activity was observed in patients with T1D at baseline, nor at 3 months, even in the subgroup of patients with optimal control (3-month HbA1c < 7%). We did not find any glycated form of apoC1 using mass spectrometry in people with T1D. Hyperglycemia in vivo does not seem to be a major factor implicated in the loss of apoC1 ability to inhibit CETP activity observed in T1D. Other factors, such as qualitative abnormalities of lipoproteins, could be involved. Our data emphasize the fact that hyperglycemia is not the only factor involved in lipid abnormalities and macrovascular complications in T1D. Clinical trial reg. no. NCT02816099 ClinicalTrials.gov.

The use of FreeStyle libre improves glycaemic control along with reducing diabetes burden and hospital admissions in a socially deprived Northwest English population.

This retrospective study aimed to use mixed (qualitative and quantitative) methods to evaluate the role of FSL in reducing hospital admissions due to all causes, HbA1c, and reported hypoglycaemic episodes in people with diabetes living in a socially deprived region of Northwest England. Data were collected retrospectively from previous consultations, which coincided with the 6th -week, 6th -month and annual review including blood tests, hospital admissions due to any cause and reported hypoglycaemia. Also, FSL assessment and satisfaction semi-structured questionnaire was done to assess the impact of FSL on diabetes management and quality of life. Mixed-effects models were used to assess glycaemic control and reductions in hospital admissions and reported hypoglycaemic episodes. Just 127 patients met the inclusion criteria. A multivariate linear mixed model method that analyses HbA1c data longitudinally revealed mean differences (mmol/mol) between baseline and post-FSL measurements, estimated by restricted maximum likelihood method (REML) of 9.64 (six weeks), 7.68 (six months) and 7.58 (annual review); all with a corresponding p-value of < 0.0001. For DKA patients, the bootstrap method revealed a significant reduction in mean HbA1c of 25.5, 95% confidence interval (CI) [8.8, 42.6] mmol/mol. It is demonstrated that FSL use for one year resulted in 59% reduction in hospital admissions and 46% reduction in reported hypoglycaemic episodes. The use of FSL resulted in statistically significant reductions in hospital admissions, HbA1c and reported hypoglycaemic episodes among diabetics in a socially deprived Northwest region of England. These outcomes show a direct association with a higher questionnaire score. The online version contains supplementary material available at 10.1007/s40200-024-01424-4.

Effectiveness of Technology-Enabled, Low Carbohydrate Dietary Interventions, in the Prevention or Treatment of Type 2 Diabetes Mellitus in Adults: A Systematic Literature Review of Randomised Controlled and Non-Randomised Trials.

Evidence suggests that low carbohydrate dietary (LCD) approaches can improve glycaemic control and may result in type 2 diabetes mellitus (T2DM) remission. This systematic literature review (SLR) aimed to assess the effectiveness of technology-enabled LCD interventions in the management of people with prediabetes or T2DM. Data sources included Medline, Embase, CINAHL, and Web of Science. Randomised (RCTs) or non-randomised (non-RCTs) controlled trials investigating the effect of technology-enabled LCDs (<130 g/day) or very low carbohydrate diets (VLCDs < 50 g/day) on glycosylated haemoglobin A1c (HbA1c) for at least three months and published in English between 2009 and 2023 were included. Risk of bias assessment, data extraction, and synthesis were conducted using standard tools and procedures. Six studies (two RCTs and four non-RCTs, total sample, n = 1519) were identified and included in the SLR. Two studies examining LCDs reported significant reductions in mean HbA1c (0.4% and -1.2%) and weight loss (-3.8 kg and -7.5 kg) at one year. Three studies examining VLCDs reported significant reductions in mean HbA1c (-0.8% to -1.3%) and weight loss (-12 kg to -14 kg) up to two years. Technology-enabled LCD or VLCD interventions can be a novel approach in helping people with prediabetes or T2DM self-manage their condition and possibly achieve remission. However, further research is required to determine the sustainability, effectiveness, and safety of this approach.

Use of Fixed-dose Combination Therapy with Remogliflozin and Vildagliptin as an Add-on Drug in Improving the Glycemic Control of Type 2 Diabetes Mellitus: An Observational Study

Objective To evaluate whether a fixed dose combination (FDC) with remogliflozin and vildagliptin as an add-on therapy can improve the glycemic control in the management of type 2 diabetes mellitus and also the non-glycemic effects on physical profile, blood pressure, lipids, and insulin resistance. Materials and Methods An observational study that included 50 poorly controlled diabetics from April 2021 to September 2021. Patients were divided into two groups – those who were prescribed this FDC by their treating physician as an add-on drug were formed as group 1 ( n = 28). Comparison group was age-matched patients who received other standard anti-diabetic medications, categorized as group 2 ( n = 22). Fasting and postprandial sugars were done at baseline, the third and sixth month; glycated hemoglobin, body mass index, blood pressure, and lipids were done at baseline and the sixth month. Changes in blood sugar levels and glycated hemoglobin (HbA1C) at the third and sixth month from the baseline were compared using the Mann-Whitney U test. P-value less than 5% was considered statistically significant. Results A statistically significant reduction in mean HbA1c was noted in group 1 [–1.80 (−3.20, −0.15)] when compared to group 2 [0.50 (0.05, 0.80)] at the end of the third month. At the end of the sixth month, a significant reduction in the HbA1c level was noted in group 1 [(7.83 ± 0.87 %) when compared to baseline (10.3 ± 1.75%)]. Change in PPBS value at the third month from baseline was also statistically significant between groups 1 and 2 (−62.0 mg%, 19.0, P = 0.003). With respect to the body mass index and blood pressure, we did not find any significant difference. Conclusion The fixed drug combination improves glycemic control by significantly reducing mean HbA1c at the third and sixth month from baseline and there was no significant effect on body mass index, blood pressure, and lipids.

Effectiveness Of Glimepiride And Glimepiride + Vitamin-C In Type-2 Diabetes Mellitus Patients Associated With SOD2 Gene Polymorphism

Introduction: Diabetes mellitus (DM) is characterized by hyperglycemia, usually associated with the rise in oxidative stress. Oxidative stress plays a major role in diabetes and its complications. Methods: 40 newly diagnosed type-II DM patients were recruited after measuring glycolated hemoglobin (HbA1c), fasting blood sugar (FBS) &amp; postprandial blood sugar (PPBS) &amp; malondialdehyde (MDA) &amp; total antioxidant capacity (TAC). Genetic test was done for detecting SOD2gene polymorphism (Superoxide dismutase). Patients were divided into two groups, group-A (n=20) &amp;B (n=20). Group–A patients were given Glimepiride (1mg) and group-B patients were given Glimepiride (1mg) + vitamin C (1000 mg) OD for 3 months. After the commencement of the study glycemic level and oxidative stress were measured and compared with basal values. Results: 3 genotypes were identified, such as CC, CT and TT. After 3 months of study, there was a significant reduction in mean HbA1c, FBS and PPBS (p&lt;0.05) in all genotypes of both group-A&amp; B, but overall the mean reduction was more in CC genotype followed by CT and then TT genotype. Oxidative stress was reduced significantly in the CC and CT genotype (p&lt;0.05) but not in the TT genotype of the group–B, whereas group-A (all 3 genotypes) had shown elevation of oxidative stress. Conclusion: Vitamin C supplementation have better control over the glycemic level and oxidative stress.

A Phase II, Randomized, Double-Blind, Double-Dummy, Active-Controlled Clinical Trial to Investigate the Efficacy and Safety of NW Low-Glu® in Patients Newly Diagnosed with Type 2 Diabetes Mellitus.

Background Medicinal plants have long been used for the treatment of type 2 diabetes mellitus (T2DM). This study aimed to investigate the hypoglycemic efficacy and safety of NW Low-Glu® (contents of one capsule are 300 mg Mas Cotek + 100 mg Cinnamomum cassia L. + 250 mg Nigella sativa L. powdered extracts) in treatment-naïve, newly diagnosed T2DM patients. Methods This was a 12-week, double-blind, double-dummy, randomized, phase 2 clinical trial. A total of 232 male and female patients aged ≥18 and ≤65 years who were newly diagnosed with T2DM and have not received any antidiabetic drugs before and were equally randomized to receive metformin (2000 mg per day), low-dose NW Low-Glu® (content of four capsules per day), or high-dose NW Low-Glu® (content of five capsules per day). Our primary objective was to measure the mean change in HbA1c between each of the experimental arms and the metformin arm. Results There was a significant reduction in mean HbA1c at 12 weeks compared to baseline in the low-dose (0.6 (1.4)%; p=0.002) and high-dose arms (0.8 (1.7)%; p=0.004). There was also a significant reduction in 2 hr PPG at 12 weeks in the low-dose (35.4 (74.9) mg/dL, p=0.001) and high-dose arms (24.7 (100.8) mg/dL, p=0.04). Weight reduction was significantly higher with both high-dose (1.1 (−1.7) Kg; p=0.005) and low-dose arms (0.9 (−1.5) Kg; p=0.023) compared to metformin (0.8 (−1.8) Kg). No serious AEs or deaths were reported. Conclusions After 3 months of treatment, NW Low-Glu® was noninferior to metformin in reducing HbA1c and 2 hr PPG, while leading to significantly higher weight reduction in newly diagnosed T2DM patients. It was also safe and well tolerated.

Efficacy and Safety of Insulin Glargine 300U/mL in People with Type2 Diabetes Uncontrolled on Basal Insulin: The 26-Week Interventional, Single-Arm ARTEMIS-DM Study.

IntroductionThe efficacy and safety of switching to insulin glargine 300 U/mL (Gla-300) in type 2 diabetes mellitus (T2DM) uncontrolled on basal insulin (BI) has been demonstrated in the North American and Western European populations; however, there is limited data from other geographical regions with different ethnicities. The ARTEMIS-DM study aimed to evaluate the efficacy and safety of Gla-300 in people with T2DM uncontrolled on BI from Asia, Latin America and Middle East Africa.MethodsThe ARTEMIS-DM was a 26-week, prospective, interventional, single-arm, phase IV study (NCT03760991). Adults with T2DM previously uncontrolled (glycated haemoglobin [HbA1c] 7.5–10%) on BI were switched to Gla-300. The primary endpoint was change in HbA1c from baseline to 26 weeks. Key secondary endpoints were changes in HbA1c (week 12), fasting plasma glucose (FPG), self-monitored plasma glucose (SMPG) and BI dose from baseline to week 26. The safety and tolerability of Gla-300 were also assessed.ResultsA total of 372 (50% male) participants were included, with mean (standard deviation [SD]) age 60.9 (10.0) years, duration of diabetes 13.11 (7.48) years and baseline HbA1c 8.67 (0.77)% (71.22 [8.44] mmol/mol). A total of 222 (59.7%) participants were using insulin glargine 100 U/mL and 107 (28.8%) were using neutral protamine Hagedorn insulin as previous BI. There were clinically significant reductions in mean HbA1c (− 0.82%; primary endpoint), FPG and SMPG levels at week 26. With a pre-defined titration algorithm, mean Gla-300 dose increased from 27.48 U (0.35 U/kg) at baseline to 39.01 U (0.50 U/kg) at week 26. Hypoglycaemia events occurred in 20.4% of the participants; 1 (0.3%) participant had a severe hypoglycaemia event.ConclusionIn people with T2DM uncontrolled on previous BI, switching to Gla-300 with optimal titration guided by an algorithm was associated with improved glycaemic control and low incidence of hypoglycaemia across multiple geographic regions.ClinicalTrials.gov identifierNCT03760991.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-022-01271-7.

Effect of Reuse of Insulin Needle on Glycaemic Control and Related Complications in Children with Type 1 Diabetes Mellitus: A Prospective Observational Study.

Background:Children with type 1 diabetes (T1D) take multiple subcutaneous injections of insulin daily to survive. It is controversial whether the insulin needles can be reused safely or not. This study assesses the effect of the reuse versus single-use of insulin needle on glycaemic control and injection-related complications.Methods:Nearly 121 children (<15 years) with T1D were prospectively observed for existing practice of needle reuse for first 3 months and then were asked to practice single-use for the next 3 months.Results:It was found that 78% participants were reusing needles more than three times. After 3 months of needle reuse, 91.3% patients had lipodystrophy. Frequency of reuse positively correlated with local redness, bleeding and leakage of insulin. The patients achieving HbA1c ≤7.5% was significantly low among those reusing needles more than four times. After 3 months of single-use, no significant difference was found in mean HbA1c. However, hyperglycaemic episodes, lipodystrophy and local complications reduced significantly. There was a significant reduction in mean HbA1c among those using needles more than six times earlier.Conclusion:Reuse of insulin needles up to six times does not affect the glycaemic control significantly. To achieve target HbA1c (<7.5%) the needle reuse should be restricted to three times only, which can also reduce injection-related local complications.

Real-world Evidence of Efficacy and Safety of SGLT2 Inhibitors as Adjunctive Therapy in Adults With Type 1 Diabetes: A European Two-Center Experience

To evaluate real-world efficacy and safety of sodium-glucose cotransporter 2 inhibitor (SGLT2i) use in combination with insulin in people with type 1 diabetes. We conducted a retrospective cohort European two-center study. Data on demographics, HbA1c, weight, insulin use, renal function, and adverse events were collected for 199 adults with type 1 diabetes who initiated a SGLT2i adjunct to insulin. Subgroup analyses were performed to identify who benefited most and who was more at risk for adverse events. Overall, significant reductions in mean HbA1c (-0.5%), weight (-2.9 kg), and daily insulin (-8.5%) were achieved after 12 months. The greatest reduction in HbA1c was obtained in individuals with baseline HbA1c >8% (-0.7% [64 mmol/mol]). The most weight loss was observed in subjects with BMI >27 kg/m2 (-3.5 kg). Individuals with baseline estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m2 showed an increase in eGFR (4.5 mL/min/1.73 m2), whereas those with urinary albumin-to-creatinine ratio (UACR) >15 mg/g showed a decrease in UACR (-16.6 mg/g). Fifty-seven individuals (28.6%) reported adverse events: 45 with genital infections (22.6%), 5 ketosis episodes (2.5%), and 7 diabetic ketoacidosis (DKA) (3.5%). No severe hypoglycemia events were reported. Our real-world data on SGLT2i showed promising results in reductions in HbA1c, weight, and insulin requirements in type 1 diabetes. Benefits were more pronounced in individuals with higher baseline HbA1c and BMI. DKA remained a major concern, despite educational measures. Further real-life evidence is still required for evaluation of SGLT2i longer-term effects and their impact on reno-cardiovascular outcomes.

Efficacy and safety of insulin degludec in renal transplant recipients with pre-existing diabetes

IntroductionGlycemic control is important in renal transplant receptions with diabetes. In the early post-transplant period, recovering renal function and concomitant steroids and immunosuppressants increase the risk of dysglycemia which adversely impacts allograft and patient survival. We evaluated the short-term efficacy and safety of insulin degludec in diabetic renal transplant patients in early post-transplant period in outpatient settings. Materials and methodsA real world prospective observational study in 61 diabetes patients with ESRD who underwent renal transplant and were followed up for three months at Endocrinology OPD post discharge, as per routine clinical practice. All patients received standard and individualized treatment with insulin degludec. The primary outcome was change in glycosylated hemoglobin (HbA1c) and the secondary outcomes included changes in fasting (FPG)and post-prandial plasma glucose (PPPG) levels and body weight. Safety assessments included reports of hypoglycemia and changes in serum levels of creatinine and tacrolimus. ResultsMean age and duration of diabetes of the participants were 53.17 ± 8.77 years and 14.55 ± 5.71 years, respectively. During follow up, there were significant reductions in mean HbA1c (8.11 ± 1.94% to 6.96 ± 1.33%) and FPG (220.61 ± 79.42 mg/dL to 120.00 ± 37.80 mg/dL) and PPPG (303.97 ± 105.90 mg/dL to 164.25 ± 51.10 mg/dL) levels. A total of 43 patients (70.49%) achieved HbA1c target of <7%. Serum levels of creatinine and tacrolimus also reduced significantly during follow up. No significant reductions in body weight. Nocturnal hypoglycemia was reported in five patients and no patients reported severe hypoglycemia. ConclusionInsulin degludec was effective and safe in long standing diabetes patients undergoing renal transplant. Insulin degludec was well tolerated and was effective in lowering FPG, PPPG and HbA1C in early post-transplant OPD settings.

Evaluating a multidisciplinary inpatient program for youth with type 1 diabetes mellitus.

Among youth with type 1 diabetes mellitus (T1D), older adolescents demonstrate more dysglycemia and less adherence to disease management. Poor disease management during this time of development can continue into adulthood, perpetuating the economic and health burden to the individual, health care system and society. This study aimed to evaluate the effectiveness of an inpatient multidisciplinary approach to treating youth with T1D. All T1D admissions to the 4 week Chronic Illness Management Program (CIMP) between 1 January 2016 and 31 December 2017 were eligible for inclusion. Data related to physiological and psychosocial outcomes were compared between admission and discharge. Follow-up data, including hemoglobin A1c (HbA1c), psychosocial measures, and health care utilization, were collected at 3, 6, and 12 months after discharge to assess sustained changes. Fifty-seven T1D admissions were included in the sample. There was a significant reduction in mean HbA1c from admission (11.1%/98 mmol/mol) to discharge (9.1%/76 mmol/mol). Patients also demonstrated significant improvements in all psychosocial outcome measures. Improvements in HbA1c were sustained at 3 months follow-up; however, average values returned to baseline by 6 months follow-up. In contrast to preadmission history, the majority of the sample reported reduced crisis health care utilization 1 year after discharge. The inpatient setting provides an intensive treatment model for diabetes management that promotes sustainable behavior change 3 months after discharge. While additional community supports are needed for long-term improvement, this program model may benefit patients who have been unable to manage their diabetes with outpatient treatment and therapy alone.

Development and implementation of a collaboration between a patient-centered medical home and community pharmacy

ObjectivesThis study aimed to describe the development and implementation strategies used in the collaboration between a patient-centered medical home (PCMH) and a grocery pharmacy chain and to evaluate the effectiveness of a community pharmacist’s clinical integration in reducing hemoglobin A1c levels at clinic and patient levels. SettingThe Kroger Co and Catholic Health Initiative St. Vincent. Practice descriptionThe Kroger Co is a large grocery store that operates 27 pharmacies in the state of Arkansas, with 20 locations in the central Arkansas area. PCMH is part of a large health system in central Arkansas with 10 primary-care clinics in the area. Practice innovationWith the transition to value-based payment models, pharmacists are being utilized in settings outside of the pharmacy. This project demonstrates a partnership between a community pharmacy and PCMH. The community pharmacist spent 20 h/week in the PCMH providing medication therapy and disease state management services. Services were focused on patients with uncontrolled diabetes. EvaluationDescriptive statistics were used to describe the distribution of the pharmacists’ time. A patient-level pre–post analysis of the mean changes in hemoglobin A1c (HbA1c) was conducted for patients who interacted directly with the pharmacist. A clinic-level analysis was conducted to evaluate changes in HbA1c compared to that in a nonequivalent control group using a standard quality measure. ResultsIn total, 312 individual patients interacted with the pharmacist. Of those patients, 228 had diabetes. A total of 111 patients underwent pre–post HbA1c analysis. In those patients, there was a statistically significant reduction in mean HbA1c . There was no difference in clinic-level results between the intervention and control locations. ConclusionCollaboration between a community pharmacy and PCMH is feasible and may improve patient care. Future research should include pharmacy-based visits and development of a process for improved communication.

Efficacy and safety of gemigliptin as add-on therapy to insulin, with or without metformin, in patients with type 2 diabetes mellitus (ZEUS II study).

The objective of this study was to evaluate the efficacy and safety of gemigliptin added to a stable dose of insulin alone or of insulin in combination with metformin in patients with type 2 diabetes mellitus. After a two-week run-in period, patients were randomized 2:1 to receive gemigliptin 50 mg or placebo once daily as add-on to background therapy with insulin or insulin plus metformin for 24 weeks. The primary endpoint was change in haemoglobin A1c (HbA1c) from baseline at Week 24. Baseline characteristics were similar between the gemigliptin (n = 188) and placebo (n = 95) groups in terms of HbA1c (8.1%). At Week 24, the gemigliptin group showed a statistically significant reduction in mean HbA1c from baseline as compared with placebo (between-group mean difference, -0.7% [95% CI, -0.9% to -0.4%]; P-value < 0.0001). The incidence of overall adverse events and the number of hypoglycaemic adverse events were similar between the study groups. Gemigliptin added to insulin alone or to insulin in combination with metformin resulted in superior glycaemic control compared to that in the placebo group and was well tolerated for 24 weeks in patients with type 2 diabetes mellitus, without causing weight gain or increasing the incidence of hypoglycaemia.

Effectiveness and Safety of Hydroxychloroquine compared to Teneligliptin in uncontrolled T2DM patients as add-on Therapy.

ObjectivesHydroxychloroquine (HCQ) 400 mg is approved by the Drug Controller General of India (DCGI) and recommended by the Research Society for the Study of Diabetes in India (RSSDI) clinical practice recommendations 2017 as add-on therapy after metformin and sulfonylurea in Type 2 Diabetes (T2DM) patients. The aim of this observational study is to compare the efficacy and safety of hydroxychloroquine 400 mg and teneligliptin 20 mg when used as add-on therapy in Indian Type 2 DM patients who were inadequately controlled (HbA1c ≥7.5%) with metformin 1000 mg and glimepiride 2 mg combination.MethodologyThis study is a prospective observational study to be conducted in 2 diabetic centres of Patna city between October 2017 and May 2018 involving 180 patients followed up for 6 months. One group (N=90) of patients received hydroxychloroquine 400 mg + metformin 1000 mg + glimepiride 2 mg, the other group (N=90) received teneligliptin 20 mg + metformin 1000 mg + glimepiride 2 mg. Efficacy was assessed by fasting blood glucose (FBG), post prandial blood glucose (PPBG) and glycated haemoglobin (HbA1c) reduction. Safety was evaluated by the number of hypoglycaemic events and changes in serum creatinine levels. Home based glucose monitoring was used to detect the hypoglycaemic events. Patients who had any type of retinopathy/maculopathy were excluded.ResultsMean age of entire population was 66±8 years with mean 6±2 years of DM with 102 males. Mean body weight was 71±12 kg. Baseline HbA1c was 8.1±0.3 in the hydroxychloroquine group and 8.2±0.2 in the teneligliptin group.At 24 weeks there were statistically significant reductions in mean HbA1c in the hydroxychloroquine group (1.1±0.3) as compared to the teneligliptin group (0.82±0.3) (P≤0.001). The mean FBG and PPBG was 169±18 mg/dl and 232±18 mg/dl respectively in hydroxychloroquine group which was reduced to 121±15 mg/dl and 161±19 mg/dl at the end of 24 weeks. In the teneligliptin group, FBG and PPBG was 171±16 mg/dl and 239±21 mg/dl at baseline, which was reduced to 121±15 mg/dl and 161±19 mg/dl respectively in same period of time (P≤ 0.005). There were 4 incidences of hypoglycaemic events in the hydroxychloroquine group (4.4%) and 6 in the teneligliptin group (6.67%). No patients required medical assistance for hypoglycaemic events. There was no statistically significant change in body weight in both the groups. No marked changes in creatinine levels were found in patients in both the groups.ConclusionIn conclusion, treatment with hydroxychloroquine 400 mg for 24 weeks reduces glycaemic parameters more aggressively than teneligliptin 20 mg in Indian type 2 diabetes patients.

Comparative Effectiveness and Maintenance of Diabetes Self-Management Education Interventions for Marshallese Patients With Type 2 Diabetes: A Randomized Controlled Trial.

Marshallese adults experience high rates of type 2 diabetes. Previous diabetes self-management education (DSME) interventions among Marshallese were unsuccessful. This study compared the extent to which two DSME interventions improved glycemic control, measured on the basis of change in glycated hemoglobin (HbA1c). A two-arm randomized controlled trial compared a standard-model DSME (standard DSME) with a culturally adapted family-model DSME (adapted DSME). Marshallese adults with type 2 diabetes (n = 221) received either standard DSME in a community setting (n = 111) or adapted DSME in a home setting (n = 110). Outcome measures were assessed at baseline, immediately after the intervention, and at 6 and 12 months after the intervention and were examined with adjusted linear mixed-effects regression models. Participants in the adapted DSME arm showed significantly greater declines in mean HbA1c immediately (-0.61% [95% CI -1.19, -0.03]; P = 0.038) and 12 months (-0.77% [95% CI -1.38, -0.17]; P = 0.013) after the intervention than those in the standard DSME arm. Within the adapted DSME arm, participants had significant reductions in mean HbA1c from baseline to immediately after the intervention (-1.18% [95% CI -1.55, -0.81]), to 6 months (-0.67% [95% CI -1.06, -0.28]), and to 12 months (-0.87% [95% CI -1.28, -0.46]) (P < 0.001 for all). Participants in the standard DSME arm had significant reductions in mean HbA1c from baseline to immediately after the intervention (-0.55% [95% CI -0.93, -0.17]; P = 0.005). Participants receiving the adapted DSME showed significantly greater reductions in mean HbA1c immediately after and 12 months after the intervention than the reductions among those receiving standard DSME. This study adds to the body of research that shows the potential effectiveness of culturally adapted DSME that includes participants' family members.

Diabetes Control: Is Vinegar a Promising Candidate to Help Achieve Targets?

Background.Renewed interest in vinegar as a glucose-lowering agent led to several small trials in the recent past. However, none of the trials could independently provide sufficient evidence.Objectives.Our review aimed to obtain reliable estimates of effects of vinegar on short-term and long-term blood glucose control.Methods.Large bibliographic databases were searched from inception to date of search without language and publication date restrictions. All clinical trials evaluating effect of vinegar on diabetes mellitus patients were eligible. Two authors independently extracted data on fasting and 2-hour postprandial blood glucose, insulin, and HbA1c levels at the various time points. MS Excel, SAS® v9.3, and RevMan v5.3 were used for data analysis.Results.Small significant reduction in mean HbA1c was observed after 8 to 12 weeks of vinegar administration: −0.39% (95% confidence interval = −0.59, −0.18; I 2 = 0%). Other long-term outcomes favored vinegar but were not significant. Short-term outcomes showed significantly lower pooled mean difference in glucose levels at 30 minutes in the vinegar group. Readings at 60, 90, and 120 minutes were lower in the vinegar group but not statistically significant. Adverse effects profile also favored the vinegar group.Conclusions.It is worthwhile to carry out carefully planned large trails to determine the efficacy and effectiveness of vinegar as an adjunct treatment modality.

Integrated Care of people with Type 2 diabetes in Western Sydney: A business case for Joint Specialist Case Conference (JSCC) with General Practice

Introduction: Type 2 diabetes is the leading burden of disease in Australia, particularly in Western Sydney, with 960,000 people and one of the fastest growing populations. Approximately 15% of the population have diabetes, 35% are at high risk of diabetes and 50% are overweight/obese. Western Sydney Diabetes (WSD) initiative was established in 2012 by Western Sydney Local Health District (hospital care) and Western Sydney Primary Health Network (primary healthcare) with a range of partners. Aim, theory, targeted population and timeline: The business case identified support to primary care through a hospital-led Joint-Specialist Case-Conference (JSCC) service with a focus on prevention and management of patients with diabetes at an individual and practice level. WSD has run a JSCC service since 2014. A diabetes specialist, resident medical staff, and diabetes nurse educator attend General Practice (GP) to conference with the GP and the patient to develop a management plan. In a session, we see up to 12 patients, 30 minutes each. With four teams doing six sessions a week, JSCC has seen over 1000 patients, and over 150 GPs. JSCC aims to keep people with diabetes well, with fewer complications and reduce the demand on hospitals. It achieves this by empowering GPs to develop their capacity to manage their patients in the long term after 10 sessions with JSCC. Highlights: We demonstrated significant benefits for the patient, including (at 3-6 month follow-up) an average HbA1c concentration reduction of 0.87% (95% CI -1.31, -0.44), mean reduction in systolic blood pressure of 6.45mmHg (95% CI -11.48, -1.41) and non-significant reductions in mean weight, total cholesterol and diastolic blood pressure. We also found a significant reduction in hospital waiting times for specialist services, from 12 to 2.5 weeks. These investigations are repeated at the 18 month follow-up. The JSCC program has high acceptance among GPs. Over 90% of GPs agree/strongly agree that JSCC was useful to their practice to build their capacity to manage patients with diabetes and would recommend it to their colleagues. The PEN Clinical Audit Tool (PENCAT) was used to track the management of patients with diabetes. Early results indicate that GP practices experienced significant reductions in mean HbA1c of all patients with diabetes (not only those who had been case conferenced) and reductions in BMI, blood pressure and indicators of care integration. Looking forward; conclusions, sustainability, and transferability: A cost-benefit analysis found that for every dollar spent on JSCC, we would see a return of over A$3. More broadly, across a number of interventions targeting diabetes prevention and management, it found that, over seven years, a $68m investment would deliver a net benefit of $124m. The flexibility of JSCC and the cultural diversity of Western Sydney (50% of the population born overseas) means the program will be easily transferrable to other primary/tertiary care environs. Discussion and lessons learned: JSCC is a cost-effective method to empower GPs to provide enhanced management of chronic diabetes care, across healthcare and community settings at a low cost to the healthcare system. We have identified a successful business model that can easily be exported to different locales and across differing types of chronic disease to better support care integration and practice.

Insulin Detemir in Combination with Oral Antidiabetic Drugs Improves Glycemic Control in Persons with Type 2 Diabetes in Near East Countries: Results from the Lebanese Subgroup.

To evaluate the effectiveness and safety of insulin detemir treatment as add-on therapy in a real-world setting of Lebanese insulin naïve persons, with type 2 diabetes poorly controlled on oral antidiabetic drugs (OADs). Our study was a prospective, observational study representing the Lebanese arm of the multinational prospective and observational study involving 2,155 persons across Near East countries, Lebanon, Pakistan, Israel and Jordan. Effectiveness endpoints were changes in HbA1c, fasting and post-prandial glucose (FPG, PPG) after 24 weeks of treatment with insulin detemir in eligible persons. Safety endpoints were number of hypoglycemic events, incidence of adverse drug reactions (ADRs), serious ADRs, adverse events, and body weight change between baseline and end of treatment. 868 persons were included (mean age: 59.5 ± 10.4 years, men: 55.3%). Glycemic control improved with significant reduction in mean HbA1c from 9.7 ± 1.6% to 7.2 ± 1% (P<.0001). The percentage of persons who achieved the target of HbA1c<7% increased from .7% at baseline to 39% at week 24. Mean FPG decreased significantly from 213.7 ± 60.1 mg/dL to 120.3 ± 25.7 mg/dL (P<.001), and mean PPG from 271 ± 65.3 mg/dL to 158.1 ± 36.4 mg/dL (P<.0001). The rate of major hypoglycemic episodes decreased from .1498 at baseline to .0448 at week 24. Three adverse events but no ADR or serious ADR were reported. Body weight decreased from 80.4±13.2 Kg to 79.9±12.5 Kg (P<.0001). Initiating insulin detemir in a clinical health care setting among Lebanese with type 2 diabetes mellitus on OADs improves glycemic control with no increase in hypoglycemia, adverse events or weight compared with baseline.

Use of V-Go® Insulin Delivery Device in Patients with Sub-optimally Controlled Diabetes Mellitus: A Retrospective Analysis from a Large Specialized Diabetes System.

IntroductionTight glycemic control and timely treatment can improve outcomes in patients with diabetes yet many remain sub-optimally controlled. The objective of the current study was to evaluate the effect of switching patients with sub-optimally controlled diabetes to the V-Go® (Valeritas Inc., Bridgewater, NJ, USA) Disposable Insulin Delivery device.MethodsA retrospective analysis of electronic medical records was conducted to assess patients with sub-optimal glycemic control defined as a glycated hemoglobin (HbA1c) >7%, switched to V-Go. Blood glucose control defined as change from baseline in HbA1c, prescribed insulin doses, body weight, concomitant anti-hyperglycemic agents, and reported hypoglycemia were collected prior to switching to V-Go and during V-Go use.ResultsTwo-hundred and four patients were evaluated during the study period. Overall, there was a significant decrease in HbA1c after switching to V-Go at the 14- and 27-week follow-up visits. The least-squares mean (LSM) change in HbA1c (95% confidence interval) from baseline to 14 weeks was −1.53% (−1.69% to −1.37%; P < 0.001), and from baseline to 27 weeks was −1.79% (−1.97% to −1.61%; P < 0.001). Significant reductions in mean HbA1c were achieved at both visits in all patient subsets: Patients with type 2 and type 1/latent autoimmune diabetes in adults (LADA); patients using insulin at baseline and patients naïve to insulin at baseline. Patients administering insulin at baseline required significantly less insulin on V-Go (86–99 LSM units/day at baseline to 58 LSM units/day at 27 weeks; P < 0.001). Across all patients, reported hypoglycemic events were no more frequent on V-Go than on previous therapy.ConclusionV-Go is safe and effective in patients with sub-optimally controlled diabetes requiring insulin therapy. Glycemic control improved significantly, less insulin was required, and hypoglycemic events were similar after patients switched to insulin delivery by V-Go.FundingValeritas, Inc.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-015-0138-7) contains supplementary material, which is available to authorized users.

Sitagliptin: Is It Effective in Routine Clinical Practice?

Aim. The present study was conducted to determine the glycaemic effects of sitagliptin in type 2 diabetes patients. Methods. Data was collected from patient medical records of a major teaching hospital in Malaysia, from 2009 to 2012. Glycated hemoglobin (HbA1c) values prior to and up to 12 months after the initiation of sitagliptin were analysed. The change in HbA1c values was accounted for based on a generalized linear model generated using the Generalized Estimating Equations (GEE) method. Results and Discussion. Of the 457 patients, 53.6% were elderly and 81.4% were overweight. The mean HbA1c (standard deviation) before initiation of sitagliptin was 8.5 (1.4)%. This dropped to 7.7 (1.4)%, 3 to 6 months after initiation of sitagliptin, with a mean difference of 0.8% (95% confidence interval (CI): 0.7–1.0; P < 0.001). However, this value increased to 8.0 (1.7)% after 7 to 12 months on sitagliptin (P = 0.002) with a mean difference from baseline of 0.6% (95% CI: 0.4–0.7; P < 0.001). Conclusion. In routine clinical practice, sitagliptin produces a significant reduction in mean HbA1c (0.8%) within the first 6 months of use which corresponds to efficacy data obtained in controlled clinical trials. However, this reduction was lesser, 7 to 12 month later.