Difference In HbA1c Reduction Research Articles

Efficacy and Safety of Fast-Acting Insulin Aspart in People with Type 1 Diabetes Using Carbohydrate Counting: A Post Hoc Analysis of Two Randomised Controlled Trials.

IntroductionInsulin dosing based on carbohydrate counting is the gold standard for improving glycaemic control in type 1 diabetes (T1D). This post hoc analysis aimed to explore the efficacy and safety of fast-acting insulin aspart (faster aspart) according to bolus dose adjustment method in people with T1D.MethodsPost hoc analysis of two 26-week, treat-to-target, randomised trials investigating treatment with double-blind mealtime faster aspart, insulin aspart (IAsp), or open-label post-meal faster aspart (onset 1, n = 1143; onset 8, n = 1025). Participants with previous experience continued carbohydrate counting (onset 1, n = 669 [58.5%]; onset 8, n = 428 [41.8%]), while remaining participants used a bolus algorithm.ResultsIn onset 1, HbA1c reduction was statistically significantly in favour of mealtime faster aspart versus IAsp with carbohydrate counting (estimated treatment difference [ETD 95% CI] − 0.19% [− 0.30; − 0.09]; − 2.08 mmol/mol [− 3.23; − 0.93]). In onset 8, there was no statistically significant difference in HbA1c reduction with either dose adjustment method, although a trend towards improved HbA1c was observed for mealtime faster aspart with carbohydrate counting (ETD − 0.14% [− 0.28; 0.003]; − 1.53 mmol/mol [− 3.10; 0.04]). In both trials, bolus insulin doses and overall rates of severe or blood glucose-confirmed hypoglycaemia were similar between treatments across dose adjustment methods.ConclusionFor people with T1D using carbohydrate counting, mealtime faster aspart may offer improved glycaemic control versus IAsp, with similar insulin dose and weight gain and no increased risk of hypoglycaemia.Trial RegistrationClinicalTrials.gov: NCT01831765 (onset 1) and NCT02500706 (onset 8).FundingNovo Nordisk.Electronic supplementary materialThe online version of this article (10.1007/s13300-019-0608-4) contains supplementary material, which is available to authorized users.

The impact of a structured education and treatment programme (FLASH) for people with diabetes using a flash sensor-based glucose monitoring system: Results of a randomized controlled trial

AimsFlash sensor-based glucose monitoring (FSGM) provides people with diabetes considerably more information on their glycaemic control. We have developed and evaluated a structured education and treatment programme, termed FLASH, to assist FSGM users to understand and use the available glycaemic information for optimization of their diabetes treatment. MethodsWe report on a multi-centre, randomized, parallel trial with a six-month follow-up involving 216 eligible participants (16–75 years old) on intensive insulin therapy. The primary outcome was HbA1c change from baseline to six months. Secondary outcomes were measures of glucose control as assessed by FSGM, as well as changes in behavioural and psychosocial measures. ResultsAt six months, the between-group difference in HbA1c reduction was significant, favouring FLASH education compared to the control group receiving no FLASH education (−0.28%, 95% CI −0.16% to −0.40% vs.−0.11%, 95% CI 0.00% to −0.22%; with a between-group difference of −0.17%, 95% CI −0.01% to −0.33%; p = 0.033). Participation in FLASH education also resulted in significant improvements in time spent in the target glucose range, in diabetes-related distress scores and in satisfaction with the glucose monitoring method. FLASH education also resulted in significant improvements in the use of glycaemic information provided by FSGM and in reduced self-monitoring of blood glucose (SMBG) fingerstick testing. ConclusionFLASH is an effective programme to improve glycaemic control and lower diabetes-related distress in users of FSGM.The study was registered in ClinicalTrials: NCT03175315.

Diode Laser - A Novel Therapeutic Approach in the Treatment of Chronic Periodontitis in Type 2 Diabetes Mellitus Patients: A Prospective Randomized Controlled Clinical Trial.

Introduction: Maturity-onset diabetes mellitus affecting the elderly population is marked by insulin resistance and decreased insulin production. The relationship between periodontitis and diabetes is bidirectional. Type 2 diabetic patients are more prone to chronic periodontitis (CP) and severe periodontitis affects the glycemic control in such patients. Recently, dental diode laser has become an effective tool in controlling CP. To date, very few studies have been conducted to check the efficacy of diode laser in control of periodontal destruction in type 2 diabetes mellitus (DM2) patients. Hence, the need of the study was to evaluate whether diode laser helps improvement of periodontal outcome and reduction in anaerobic bacteria in elderly diabetic patients with CP. Methods: Forty DM2 patients with CP were randomized into group A (control): scaling and root planing (SRP) only and group B (test): SRP followed by soft tissue dental diode laser (808 nm) application. Four patients (2 in each group) were lost during follow up. Clinical parameters, plaque samples and glycated hemoglobin levels were evaluated at both baseline and 90 days post-treatment. Results: Improvement in clinical, microbiological and glycemic parameters were noted in the group that received SRP as well as SRP + LANAP (laser-assisted new attachment procedure). The reductions in clinical parameters were statistically significant after 3 months (P<0.001). The microbial analysis of plaque samples for Aggregatibacter actinomycetemcomitans (Aa) and Porphyromonas gingivalis (Pg) decreased significantly after 3 months in group B than in group A. Glycated hemoglobin level (HbA1c) decreased significantly after 90 days in both the groups (P<0.001) with more reduction in the SRP+LANAP group (6.49%) in comparison to SRP alone (16.25% vs. 9.76%). However, on the intergroup comparison, the difference in HbA1c reduction was nonsignificant. Conclusion: Laser as an adjunct to SRP is an effective procedure for improving clinical and microbiological parameters in maturity onset diabetes mellitus patients with CP. Also, there was a better improvement in glycemic control in the test group compared to control group after 3 months. Hence, medically compromised patients like DM2 with CP with delayed wound healing can effectively be treated by laser as an adjunct to nonsurgical periodontal therapy for better results.

Efficacy of an Education Program for People With Diabetes and Insulin Pump Treatment (INPUT): Results From a Randomized Controlled Trial.

Continuous subcutaneous insulin infusion (CSII) is the most advanced form of insulin delivery, but it requires structured education to provide users with the necessary knowledge/skills and to support their motivation. Currently, no structured education program designed to provide this training has been evaluated. We developed a CSII-specific, structured education program (Insulin Pump Treatment [INPUT]) and evaluated its impact on glycemic control, behavior, and psychosocial status. This was a multicenter, randomized, parallel trial with a 6-month follow-up. Eligible participants (age 16-75 years) currently were treated with insulin pump therapy. Participants were randomly assigned (1:1) to the INPUT program or to usual care using a computer-generated algorithm, with study center as the stratification factor. The primary outcome was HbA1c change from baseline to 6 months. Secondary outcomes were incidence of severe hypoglycemia and changes in behavioral and psychosocial measures. Between 1 April 2016 and 26 April 2016, 268 people with diabetes and a mean duration of CSII therapy of 9.5 years were randomly assigned to the INPUT group (n = 135) or control group (n = 133). At 6 months, HbA1c improved in the INPUT group (8.33 ± 0.8 vs. 8.04 ± 0.9; P < 0.0001) but not in the control group (8.33 ± 1.0 vs. 8.27 ± 1.0; P = 0.11). The between-group difference in HbA1c reduction was significant, favoring INPUT (-0.28% vs. -0.06%, Δ -0.22%, 95% CI -0.38 to -0.06; P = 0.0029). The incidence rate ratio of severe hypoglycemia was 3.55 times higher for participants in the control group than for those in the INPUT group (95% CI 1.50-8.43; P = 0.0041). The INPUT education program led to a significant improvement in glycemic control and incidence of severe hypoglycemia in insulin pump users.

Individualized Meal Replacement Therapy Improves Clinically Relevant Long-Term Glycemic Control in Poorly Controlled Type 2 Diabetes Patients.

Background Formula diets can improve glycemic control or can even induce remission in type 2 diabetes. We hypothesized that especially an individualized intense meal replacement by a low-carbohydrate formula diet with accompanied self-monitoring of blood glucose (SMBG) contributes to long-term improvements in HbA1c, weight, and cardiometabolic risk factors in poorly controlled type 2 diabetes. Methods Type 2 diabetes patients were randomized into either a moderate group (M-group) with two meal replacements/day (n = 160) or a stringent group (S-group) with three meal replacements/day (n = 149) during the first week of intervention (1300–1500 kcal/day). Subsequently, both groups reintroduced a low-carbohydrate lunch based on individual adaption due to SMBG in weeks 2–4. After week 4, breakfast was reintroduced until week 12. During the follow-up period, all of the participants were asked to continue replacing one meal per day until the 52-weeks follow-up. Additionally, an observational control group (n = 100) remained in routine care. Parameters were compared at baseline, after 12 and 52 weeks within and between all of the groups. Results 321 participants (83%) completed the acute meal replacement phase after 12 weeks and 279 participants (72%) the whole intervention after 52 weeks. Both intervention groups achieved improvements in HbA1c, fasting blood glucose, blood pressure, and weight (all p < 0.001) within 12 weeks. However, these results were not significantly different between both of the intervention groups. The estimated treatment difference in HbA1c reduction was (mean (95% confidence interval [CI]) -0.10% with 95% CI [−0.40; 0.21] also (p > 0.05) (S-group vs. M-group) not statistically different after 12 weeks. However, only the S-group showed a clinically relevant improvement in HbA1c of −0.81% [−1.06; −0.55] (p < 0.001) after 52 weeks of follow-up, whereas HbA1c was not statistically different between the M- and control group. Conclusion Individualized meal replacement with SMBG demonstrated beneficial effects on HbA1c and cardiometabolic parameters in type 2 diabetes. Furthermore, the initiation of a weight loss program with one week of full meal replacement (three meals per day) resulted in a clinically relevant long-term HbA1c reduction, as compared to an observational control group that had standard care.

Baseline factors associated with better response to insulin lispro low mixture or insulin glargine: A post hoc analysis of the DURABLE study

AimsTo identify baseline characteristics associated with better efficacy and safety responses to twice-daily insulin lispro low mixture (LM) or once-daily insulin glargine (IG) in insulin-naïve patients with type 2 diabetes (T2D). MethodsThis post hoc analysis of the DURABLE study used the gradient-boosting method to generate hypothetical outcomes with the alternative treatment to assigned study drug to evaluate the potential additional benefit of one insulin over the other in association with influential baseline covariates in the same patient. The magnitude of additional benefit was further quantified by the generalized linear model and recursive partitioning regression tree method. ResultsBaseline characteristics with the highest relative influence on 24-week outcomes in the overall population (LM, n = 1045; IG, n = 1046) were: for HbA1c change: fasting plasma glucose (FPG) (29.31%), age (28.57%); for reaching target HbA1c <7% (<53 mmol/mol): weight (22.41%); for weight change: weight (18.54%); for FPG: FPG (43.66%), age (20.8%); for 30-day hypoglycemia: FPG (57.09%), weight (10.1%). LM showed superiority over IG for HbA1c reduction and reaching HbA1c <7% overall, with clinically significant differences in HbA1c reduction (>0.4%) in some subpopulations. IG was superior over LM in most patients for less weight gain and hypoglycemia and lower FPG. ConclusionsDifferences in magnitude of response to twice-daily LM and once-daily IG in association with baseline characteristics of insulin-naïve patients with T2D were found. Future real-world studies using these statistical methods could help identify patients who respond better to certain insulin regimens to help guide clinicians in treatment decisions.

Diabetes App-Related Text Messages From Health Care Professionals in Conjunction With a New Wireless Glucose Meter With a Color Range Indicator Improves Glycemic Control in Patients With Type 1 and Type 2 Diabetes: Randomized Controlled Trial.

BackgroundMobile diabetes apps enable health care professionals (HCPs) to monitor patient progress, offer remote consultations, and allow more effective and informed treatment decisions between patients and HCPs. The OneTouch Reveal app aggregates data from a blood glucose meter and provides analytics to help patients and HCPs visualize glycemic trends and patterns, enabling more informed treatment and lifestyle decisions. The app also allows patients and HCPs to keep connected by exchanging text messages (short message service [SMS]) or progress reports via email.ObjectiveThe primary objective of our study was to assess changes in glycemic control and overall experiences of patients and HCPs using the app in conjunction with the wireless OneTouch Verio Flex blood glucose meter.MethodsWe randomly assigned 137 adults with type 1 (T1DM) or type 2 diabetes mellitus (T2DM) and a glycated hemoglobin (HbA1c) level of ≥7.5% and ≤11.0% to use the glucose meter alone or glucose meter plus the app for 24 weeks. The meter + app group were scheduled to receive diabetes-related text messages from their HCP every 2 weeks (total of 12 texts). Clinical measures and self-reported outcomes were assessed during face-to-face clinic visits between the participant and a diabetes nurse at baseline, week 12, and week 24.ResultsIn 128 completed participants, HbA1c decreased after 12 and 24 weeks in both the meter-only (n=66) (0.56% and 0.55%, respectively) and meter + app groups (n=62) (0.78% and 0.67%, respectively) compared with baseline (each P<.001). The difference in HbA1c reduction between the 2 groups was not statistically significant at 12 or 24 weeks (P=.12 and P=.45, respectively). However, the decrease in HbA1c was greater in T2DM participants using the meter + app after 12 weeks (1.04%) than in T2DM participants using the meter alone (0.58%; P=.09). In addition, decrease in HbA1c in participants using the meter + app who received at least 10 diabetes-related text messages (1.05%) was significantly greater than in meter-only participants (P<.01).ConclusionsUse of the OneTouch Verio Flex glucose meter alone or in combination with the OneTouch Reveal diabetes app was associated with significant improvements in glycemic control after 12 and 24 weeks. Improvements using the app were greatest in participants with T2DM and those participants who received the highest number of HCP text messages. This study suggests that real-time availability of patient data and the ability to send personalized diabetes-related text messages can assist HCPs to improve glycemic control in patients between scheduled visits.Trial RegistrationClinicaltrials.gov NCT02429024; https://clinicaltrials.gov/ct2/show/NCT02429024 (Archived by WebCite at http://www.webcitation.org/6sCTDRa1l)

Efficacy of the Telemedical Lifestyle intervention Program TeLiPro in Advanced Stages of Type 2 Diabetes: A Randomized Controlled Trial.

Lifestyle interventions are the foundation of treatment in newly diagnosed type 2 diabetes. However, their therapeutic potential in advanced disease stages is unknown. We evaluated the efficacy of the Telemedical Lifestyle intervention Program (TeLiPro) in improving metabolic control in advanced-stage type 2 diabetes. In this single-blind, active comparator, intervention study, patients with type 2 diabetes (with glycated hemoglobin [HbA1c] ≥7.5% [58.5 mmol/mol]), and BMI ≥27 kg/m2 and on ≥2 antidiabetes medications) were recruited in Germany and randomized 1:1 using an electronically generated random list and sealed envelopes into two parallel groups. The data analyst was blinded after assignment. The control group (n = 100) got weighing scales and step counters and remained in routine care. The TeLiPro group (n = 102) additionally received telemedical coaching including medical-mental motivation, a formula diet, and self-monitored blood glucose for 12 weeks. The primary end point was the estimated treatment difference in HbA1c reduction after 12 weeks. All available values per patient (n = 202) were analyzed. Analyses were also performed at 26 and 52 weeks of follow-up. HbA1c reduction was significantly higher in the TeLiPro group (mean ± SD -1.1 ± 1.2% vs. -0.2 ± 0.8%; P < 0.0001). The estimated treatment difference in the fully adjusted model was 0.8% (95% CI 1.1; 0.5) (P < 0.0001). Treatment superiority of TeLiPro was maintained during follow-up (week 26: 0.6% [95% CI 1.0; 0.3], P = 0.0001; week 52: 0.6% [0.9; 0.2], P < 0.001). The same applies for secondary outcomes: weight (TeLiPro -6.2 ± 4.6 kg vs. control -1.0 ± 3.4 kg), BMI (-2.1 ± 1.5 kg/m2 vs. -0.3 ± 1.1 kg/m2), systolic blood pressure (-5.7 ± 15.3 mmHg vs. -1.6 ± 13.8 mmHg), 10-year cardiovascular disease risk, antidiabetes medication, and quality of life and eating behavior (P < 0.01 for all). The effects were maintained long-term. No adverse events were reported. In advanced-stage type 2 diabetes, TeLiPro can improve glycemic control and may offer new options to avoid pharmacological intensification.

Video consultations as add-on to standard care among patients with type 2 diabetes not responding to standard regimens: a randomized controlled trial.

To examine whether video consultations preceded by measurements of blood glucose, weight and blood pressure as add-on to standard care could contribute to achieving and maintaining good diabetes control among patients with poorly regulated type 2 diabetes (T2D). Randomized controlled trial. 165 patients with T2D were randomized 1:1 to telemedicine intervention as add-on to clinic-based care or control (clinic-based care). The intervention consisted of monthly video conferences with a nurse via a tablet computer and lasted for 32 weeks. Regularly self-monitored measurements of blood sugar, blood pressure and weight were uploaded and visible to patient and nurse. Both groups were followed up six months after the end of the intervention period. HbA1c after eight months. Video conferences preceded by uploads of measurements as add-on to clinic-based care led to a significant reduction of HbA1c compared to that in standard care (0.69% vs 0.18%, P = 0.022). However, at six-month follow-up, the inter-group difference in HbA1c-reduction was no longer significant. Non-completers had higher HbA1c levels at baseline and a lower degree of education. Video consultations preceded by uploading relevant measurements can lead to clinically and statistically significant improvements in glycemic control among patients who have not responded to standard regimens. However, continuing effort and attention are essential as the effect does not persist when intervention ends. Furthermore, future studies should focus on differentiation as the most vulnerable patients are at greater risk of non-adherence.

Effects of a lifestyle education program on glycemic control among patients with diabetes at Kigali University Hospital, Rwanda: A randomized controlled trial.

Evidence to show whether lifestyle intervention programs are beneficial for patients with diabetes in resource-limited countries is lacking. The present study assessed the additional efficacy of a structured lifestyle education program, as compared to the current standard of diabetic care in Rwanda. 251 consecutive adult patients attending a tertiary diabetic care practice were randomly assigned to either an intervention group (standard of care plus monthly lifestyle group education sessions of 45min duration) or to a control group. The primary outcome was between-groups difference in glycated hemoglobin (HbA1c) observed after 12-months follow up. Outcome measures in the intervention and control groups were compared using the ANCOVA test with a two-sided significance of 5%. Of the 251 subjects recruited, 223 were included in the analysis; of whom 115 were assigned to the intervention group, and 108 to the control group. After 12-months, the median HbA1c levels reduced by 1.70 (95% CI: -2.09 to -1.31; p<0.001) in the intervention group; and by 0.52 (95% CI: -0.95 to -0.10; p=0.01) in the control group. The difference in HbA1c reduction between the intervention and control groups was statistically significant (p<0.001) after adjustment for subjects' age, sex, education level, BMI, diabetes duration and diabetic medications. This study demonstrated that a structured lifestyle group education program for people with diabetes is an attractive option in a resource-limited setting, as it showed significant benefits in improved glycemic control over a 12-month period. ClinicalTrials.gov: NCT02032108.

Continuous Glucose Monitoring Use in Type 1 Diabetes: Longitudinal Analysis Demonstrates Meaningful Improvements in HbA1c and Reductions in Health Care Utilization.

Real-time continuous glucose monitoring (rtCGM) improves glycemic control in type 1 diabetes (T1D) patients treated with continuous subcutaneous insulin infusion (CSII). However, the benefits of rtCGM in T1D patients treated with multiple daily insulin injection (MDI) therapy has not been well studied. We explored the effects of rtCGM versus self-monitoring of blood glucose (SMBG) on clinical outcomes within a large T1D population treated with either CSII or MDI therapy. This retrospective, longitudinal analysis utilized datasets from T1D patients enrolled in a commercial health plan to assess changes in HbA1c in 187 naïve to rtCGM users and 6260 SMBG users. Propensity score modeling was used to assess inpatient admissions, emergency room (ER) visits in 1130 patients (565 rtCGM, 565 SMBG). Differences in HbA1c reduction (rtCGM+MDI vs rtCGM+CSII) were evaluated. Larger, clinically meaningful HbA1c reductions were seen among rtCGM versus SMBG users: -0.5% ( P = .004) versus -0.2% ( P < .0001); 0.3% diff in diff, P = .03. All-cause inpatient admissions were lower for rtCGM users: -42%, P = .013. Emergency room visits coded for diabetic ketoacidosis (DKA) were four times higher for SMBG patients than rtCGM patients: 17 versus 4, P = .0318. HbA1c reductions were most notable with rtCGM+MDI versus rtCGM+CSII treatment: -0.6% ( P = .01) versus -0.3% ( P = .16). Use of rtCGM in T1D patients facilitates greater HbA1c improvements and reduced health care system utilization compared with traditional SMBG use regardless of insulin administration method. Treatment with rtCGM in conjunction with MDI confers similar or greater glycemic benefits without the additional costs associated with CSII therapy.

Cost-effectiveness of dipeptidyl peptidase-4 inhibitor monotherapy versus sulfonylurea monotherapy for people with type 2 diabetes and chronic kidney disease in Thailand

Objective: With a high prevalence of chronic kidney disease (CKD) in type 2 diabetes (T2DM) in Thailand, the appropriate treatment for the patients has become a major concern. This study aimed to evaluate long-term cost-effective of dipeptidyl peptidase-4 (DPP-4) inhibitor monothearpy vs sulfonylurea (SFU) monotherapy in people with T2DM and CKD.Methods: A validated IMS CORE Diabetes Model was used to estimate the long-term costs and outcomes. The efficacy parameters were identified and synthesized using a systematic review and meta-analysis. Baseline characteristics and cost parameters were obtained from published studies and hospital databases in Thailand. Costs were expressed in 2014 US Dollars. Outcomes were presented as an incremental cost-effectiveness ratio (ICER). One-way and probabilistic sensitivity analyses were performed to estimate parameter uncertainty.Results: From a societal perspective, treatment with DPP-4 inhibitors yielded more quality-adjusted life years (QALYs) (0.024) at a higher cost (>66,000 Thai baht (THB) or >1,829.27 USD) per person than SFU, resulting in the ICER of >2.7 million THB/QALY (>74,833.70 USD/QALY). The cost-effectiveness results were mainly driven by differences in HbA1c reduction, hypoglycemic events, and drug acquisition cost of DPP-4 inhibitors. At the ceiling ratio of 160,000 THB/QALY (4,434.59 USD/QALY), the probability that DPP-4 inhibitors are cost-effective compared to SFU was less than 10%.Conclusions: Compared to SFU, DPP-4 inhibitor monotherapy is not a cost-effective treatment for people with T2DM and CKD in Thailand.

Efficacy and safety of linagliptin in type 2 diabetes patients with self-reported hepatic disorders: A retrospective pooled analysis of 17 randomized, double-blind, placebo-controlled clinical trials

AimsLiver disease is highly prevalent among people with type 2 diabetes mellitus (T2DM). We evaluated the dipeptidyl peptidase-4 inhibitor linagliptin in subjects with T2DM and hepatic disorders. MethodsData were pooled from 17 randomized, double-blind, placebo-controlled clinical trials of linagliptin in T2DM subjects that included individuals with self-reported history of hepatic disorders at baseline. The primary endpoint was change in HbA1c from baseline to week 24. ResultsOf the 7009 participants (56% white, 39% Asian), 574 had hepatic disorders, most commonly hepatic steatosis (60%). At week 24, adjusted mean±standard error (SE) change in HbA1c from baseline in those with hepatic disorders was −0.75%±0.05 with linagliptin and −0.20%±0.08 with placebo [treatment difference: −0.54% (95% confidence interval−0.72 to −0.36); P<.0001]. There was no significant difference in HbA1c reduction between subjects with or without baseline hepatic disorders (P=.4042). Among subjects with hepatic disorders, 13.5% and 14.8% of the linagliptin and placebo groups, respectively, reported drug-related adverse events while 10.4% and 15.9%, respectively, reported hypoglycemia. Overall, adverse event rates were similar in individuals with or without hepatic disorders. ConclusionsThis large pooled analysis suggests that linagliptin is effective and well tolerated in people with T2DM and liver disease.

National Variations in Comorbidities, Glycosylated Hemoglobin Reduction, and Insulin Dosage in Asian Patients with Type 2 Diabetes: The FINE-Asia Registry.

IntroductionThe First Basal Insulin Evaluation (FINE) Asia study was a prospective, observational registry evaluating basal insulin initiation in Asian patients with type 2 diabetes mellitus inadequately controlled by oral antihyperglycemic agents.MethodsThe objective of this post hoc analysis was to observe and report the findings from individual participating countries. The primary endpoint was change in glycosylated hemoglobin (HbA1c) from baseline to month 6 after basal insulin initiation. Secondary endpoints included change in fasting blood glucose (FBG), percent of patients achieving target HbA1c and FBG levels, average insulin doses, and hypoglycemic events.ResultsThe study included 2921 patients from 11 Asian countries at baseline, 2679 (92%) of whom had evaluable data. Following initiation of basal insulin (neutral protamine Hagedorn insulin, glargine, or detemir), there was a significant (P < 0.001) difference in HbA1c reduction and proportions of patients meeting HbA1c and FBG targets (<7% and <110 mg/dL, respectively) across all country cohorts by month 6. Glycemic control also varied greatly, with 7.4% (Taiwan) to 71.5% (China) of patients reaching target HbA1c <7% levels. Mean (±standard deviation) insulin dose increases over the 6-month period ranged from 0.5 ± 3.1 U (Pakistan) to 6.0 ± 8.6 U (Thailand). Hypoglycemia rates also varied, with 7.1% (India) to 27.3% (China) of patients experiencing one or more events.ConclusionsData from the FINE-Asia registry study show widely varying degrees of baseline comorbidities and glycemic control in patients among the country cohorts observed. Countries with >9 years of diabetes prior to insulin initiation had the lowest reductions in HbA1c and proportions of patients achieving HbA1c and FBG targets, suggesting that earlier basal insulin initiation may afford better glycemic control in these patients.FundingThis study was funded by Sanofi.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-015-0137-8) contains supplementary material, which is available to authorized users.

Efficacy and safety of sitagliptin added to insulin in Japanese patients with type 2 diabetes: the EDIT randomized trial.

AimsTo clarify the efficacy and safety of adding sitagliptin to insulin therapy in Japanese patients with suboptimally controlled type 2 diabetes (T2DM).Study Design and MethodsThis was a 24-week, prospective, randomized, open-labeled, controlled trial. Patients with T2DM who were suboptimally controlled despite receiving at least twice daily injection of insulin were enrolled in the study. The patients were randomized to continuation of insulin treatment (Insulin group) or addition of sitagliptin 50 to 100 mg daily to insulin treatment (Ins+Sita group). The primary outcome was change in HbA1c at week 24.ResultsAdding sitagliptin to insulin significantly reduced HbA1c from 7.9 ± 1.0% at baseline to 7.0 ± 0.8% at week 24 (P <0.0001), while there was no significant change in HbA1c in the Insulin group (7.8 ± 0.7% vs. 7.8 ± 1.1%, P = 0.32). The difference in HbA1c reduction between the groups was 0.9% (95% confidence interval, 0.4 to 1.5, P = 0.01). There was no significant weight gain in either group. Incidence of hypoglycemia was significantly reduced in the Ins+Sita group compared with the Insulin group. Treatment satisfaction was improved in the Ins+Sita group. Baseline HbA1c level and beta cell function were associated with the magnitude of reduction in HbA1c in the Ins+Sita group.ConclusionAdding sitagliptin to insulin reduced HbA1c without weight gain or increase in hypoglycemia, and improved treatment satisfaction in Japanese patients with T2DM who were suboptimally controlled despite at least twice daily injection of insulin.Trial RegistrationThe University Hospital Medical Information Network (UMIN) Clinical Trials Registry UMIN000004678

Continuous glucose monitoring in people with diabetes: the randomized controlled Glucose Level Awareness in Diabetes Study (GLADIS).

To investigate the best glucose monitoring strategy for maintaining euglycaemia by comparing self-monitoring of blood glucose with continuous glucose monitoring, with or without an alarm function. A 100-day, randomized controlled study was conducted at four European centres, enrolling 160 patients with Type 1 or Type 2 diabetes, on multiple daily insulin injections or continuous subcutaneous insulin infusion. Participants were randomized to continuous glucose monitoring without alarms (n=48), continuous glucose monitoring with alarms (n=49) or self-monitoring of blood glucose (n=48). Time spent outside the glucose target during days 80-100 was 9.9h/day for the continuous glucose monitoring without alarms group, 9.7h/day for the continuous glucose monitoring with alarms group and 10.6h/day for the self-monitoring of blood glucose group (P=0.18 and 0.08 compared with continuous glucose monitoring without and with alarms, respectively).The continuous glucose monitoring with alarms group spent less time in hypoglycaemia compared with the self-monitoring of blood glucose group (1.0h/day and 1.6h/day, respectively; 95% CI -1.2 to -0.1; P=0.030). Among those treated with continuous subcutaneous insulin infusion, time spent outside the glucose target was significantly different when comparing continuous glucose monitoring without alarms and self-monitoring of blood glucose (-1.9h/day; 95% CI -3.8 to 0.0; P=0.0461) and when comparing continuous glucose monitoring with alarms and self-monitoring of blood glucose (-2.4h/day; 95% CI -4.1 to -0.5; P=0.0134). There was no difference in HbA1c reduction from baseline in the three groups; however, the proportion of participants with a reduction of≥6mmol/mol (≥0.5%) was higher in the continuous glucose monitoring without alarms (27%) and continuous glucose monitoring with alarms groups (25%) than in the self-monitoring of blood glucose group (10.6%). This study shows that the use of continuous glucose monitoring reduces time spent outside glucose targets compared with self-monitoring of blood glucose, especially among users of insulin pumps.

Color Record in Self-Monitoring of Blood Glucose Improves Glycemic Control by Better Self-Management

Color affects emotions, feelings, and behaviors. We hypothesized that color used in self-monitoring of blood glucose (SMBG) is helpful for patients to recognize and act on their glucose levels to improve glycemic control. Here, two color-indication methods, color record (CR) and color display (CD), were independently compared for their effects on glycemic control in less frequently insulin-treated type 2 diabetes. One hundred twenty outpatients were randomly allocated to four groups with 2×2 factorial design: CR or non-CR and CD or non-CD. Blood glucose levels were recorded in red or blue pencil in the CR arm, and a red or blue indicator light on the SMBG meter was lit in the CD arm, under hyperglycemia or hypoglycemia, respectively. The primary end point was difference in glycated hemoglobin (HbA1c) reduction in 24 weeks. Secondary end points were self-management performance change and psychological state change. HbA1c levels at 24 weeks were significantly decreased in the CR arm by -0.28% but were increased by 0.03% in the non-CR arm (P=0.044). In addition, diet and exercise scores were significantly improved in the CR arm compared with the non-CR arm. The exercise score showed significant improvement in the CD arm compared with the non-CD arm but without a significant difference in HbA1c reduction. Changes in psychological states were not altered between the arms. CR has a favorable effect on self-management performance without any influence on psychological stress, resulting in improved glycemic control in type 2 diabetes patients using less frequent insulin injection. Thus, active but not passive usage of color-indication methods by patients is important in successful SMBG.

Estudio observacional de eficacia y seguridad del cambio de insulina NPH a glargina en atención primaria. Estudio LAURA

ObjectiveTo assess the efficacy and safety of insulin Glargine in the Primary Care setting for patients with type2 diabetes mellitus (DM2) previously treated with NPH insulin. Material and methodsThis was an observational retrospective study, with 46participating Primary Care physicians, who recorded the clinical information of patients treated with NPH insulin and who switched to insulin Glargine or continued on NPH for 3-9months (inclusion design 2Glargine:1NPH). ResultsA total of 122patients in the Glargine group, and 57patients in the NPH insulin group were evaluated; the patients had a mean age of 67.0 (9.8) years, and 51.4% were males. A difference in HbA1c reduction was seen when comparing the Glargine and NPH groups: 1.07 (0.93)% vs. 0.28 (0.67)%, respectively (P<.001); fasting plasma glucose reductions were 38.4 (37.0)mg/dl vs. 15.7 (28.6)mg/dl, respectively (P<.001). Inadequate control (HbA1c≥7%) at final visit was noted in 61.3% vs. 76.8% of patients (P=.028), respectively. Total hypoglycemic and nocturnal hypoglycemic episodes within one month prior to final visit were 6.6% vs. 43.9%, and 2.5% vs. 21.1%, respectively (P<.0001). The variables associated with better glycemic control were lower baseline HbA1c and fasting plasma glucose values, and the switch to Glargine. The main reason for change was the advantage of one injection a day. ConclusionPatients with DM2 who are treated with NPH insulin in Primary Care and switch to Glargine show better glycemic control and experience fewer total and nocturnal hypoglycemic episodes.

Efficacy of Continuous Glucose Monitoring in Improving Glycemic Control and Reducing Hypoglycemia: A Systematic Review and Meta-Analysis of Randomized Trials

We conducted a systematic review and meta-analysis to assess the efficacy of continuous glucose monitoring (CGM) in improving glycemic control and reducing hypoglycemia compared to self-monitored blood glucose (SMBG). We searched MEDLINE, EMBASE, Cochrane Central, Web of Science, and Scopus for randomized trials of adults and children with type 1 or type 2 diabetes mellitus (T1DM or T2DM). Pairs of reviewers independently selected studies, assessed methodological quality, and extracted data. Meta-analytic estimates of treatment effects were generated using a random-effects model. Nineteen trials were eligible and provided data for meta-analysis. Overall, CGM was associated with a significant reduction in mean hemoglobin A1c [HbA1c; weighted mean difference (WMD) of -0.27% (95% confidence interval [CI] -0.44 to -0.10)]. This was true for adults with T1DM as well as T2DM [WMD -0.50% (95% CI -0.69 to -0.30) and -0.70 (95% CI, -1.14 to -0.27), respectively]. No significant effect was noted in children and adolescents. There was no significant difference in HbA1c reduction between studies of real-time versus non-realtime devices (WMD -0.22%, 95% CI, -0.59 to 0.15 versus -0.30%, 95% CI, -0.49 to -0.10; p for interaction 0.71). The quality of evidence was moderate due to imprecision, suggesting increased risk for bias. Data for the incidence of severe or nocturnal hypoglycemia were sparse and imprecise. In studies that reported patient satisfaction, users felt confident about the device and gave positive reviews. Continuous glucose monitoring seems to help improve glycemic control in adults with T1DM and T2DM. The effect on hypoglycemia incidence is imprecise and unclear. Larger trials with longer follow-up are needed to assess the efficacy of CGM in reducing patient-important complications without significantly increasing the burden of care for patients with diabetes.

Efficacy of Thrice-daily versus Twice-daily Insulin Regimens on Glycohemoglobin (Hb A1c) in Type 1 Diabetes Mellitus: A Randomized Controlled Trial

To improve glycemic control and prevent late complications, the patient and diabetes team need to adjust insulin therapy. The aim of this study is to evaluate the efficacy of thrice-daily versus twice-daily insulin regimens on HbA1c for type 1 diabetes mellitus by a randomized controlled trial in Hamedan, west of Iran. The study included 125 patients under 19 years of age with type 1 diabetes mellitus over a 3-month period. All patients with glycohemoglobin (HbA1c) ≥8% were followed prospectively and randomized into two trial and control groups. The control group received conventional two insulin injections per day: a mixture of short-acting (regular) + intermediated acting (NPH) insulins pre-breakfast (twice daily), and the trial group was treated by an extra dose of regular insulin before lunch (three times daily). Main outcome measure was HbA1c at baseline and at the end of 3 months. The mean blood glucose level and number of hypoglycemia were recorded. All patients underwent monthly intervals follow up for assessing their home blood glucose records and insulin adjustment. Overall, 100 patients completed the study protocol. 52% were females, mean ±SD of age of 12.91 ± 3.9 years. There were no significant differences in baseline characteristics including age, gender, pubertal stage, adherence to diet, duration of disease and total daily insulin dose (p>0.05). There was a significant decrease individually in both groups in HbA1c level (p<0.05), but there was no significant difference in HbA1c reduction in patients on twice-daily insulin injections and those on thrice-daily insulin injection groups (1.12 ± 2.12 and 0.98±2.1% respectively, p>0.05). Compared with twice daily insulin, a therapeutic regimen involving the addition of one dose regular insulin before lunch caused no significant change in the overall glycemic control of patients with type 1 diabetes mellitus. Our results emphasize that further efforts for near normoglycemia should be focused upon education of patients in terms of frequent outpatient visits, more blood glucose monitoring and attention to insulin adjustments.