Significant Reduction In HbA1c Research Articles

Self-management in patients with type 2 diabetes: Group-based versus individual education. A systematic review with meta-analysis of randomized trails

AimPatient education is an essential component of the treatment of type 2 diabetes mellitus (T2DM). The present meta-analysis was aimed at verifying the efficacy of group-based versus individual education for self-management in patients with T2DM. Data synthesisA Medline and Embase search up to January 1st, 2021, was performed, including Randomized Controlled Trials (RCT) with duration>6 months, enrolling patients with T2DM and comparing individual-based with group-based educational programs. The primary outcome was endpoint HbA1c; secondary endpoints were lipid profile, body weight, blood pressure, patients’ adherence/knowledge, and quality of life. The weighed difference in means (WMD) and Mantel-Haenzel Odds Ratio (MH–OR), with 95% Confidence Interval (CI), were calculated.We retrieved 14 RCT. No significant between-group difference in HbA1c (WMD -0.39[-0.89; 0.09] mmol/mol, p = 0.11) was observed. At metaregression analyses, longer trial duration, higher baseline mean age and duration of diabetes, and lower baseline HbA1c were correlated with greater efficacy of group-based programs in reducing HbA1c. When analyzed separately, trials excluding insulin-treated patients showed a significant reduction of HbA1c in favor of group education. ConclusionsIn patients with T2DM, group education has similar efficacy as individual education on glucose control. Group programs are associated with an improved quality of life and patients’ knowledge. Prospero and OSF registrationID243149.

Effect of SGLT2 inhibition on coronary microvascular function in patients with type 2 diabetes

Abstract Background Treatment with sodium-glucose cotransporter 2 (SGLT2) inhibitor reduces risk of cardiovascular death and heart failure but the underlying mechanisms remain poorly understood. It has been suggested that a shift in fuel source in the myocardium from glucose and free fatty acids to the more energy efficient ketogenesis reduces oxidative stress involved in coronary microvascular damage, leading to improved coronary microvascular function. Purpose To test the hypothesis that treatment with the SGLT2 inhibitor empagliflozin improves non-endothelial dependent coronary microvascular function. Methods We included 26 patients with type 2 diabetes in a double blinded, placebo-controlled cross-over study. Participants were treated with empagliflozin 25 mg and placebo for 12 weeks, interrupted by 2 weeks wash-out period. The primary outcome was change in coronary microvascular function, assessed as coronary flow velocity reserve (CFVR) and measured with transthoracic doppler echocardiography. Secondary endpoints were change in echocardiographic parameters of cardiac systolic function and 184 cardiovascular protein biomarkers. Results Nineteen patients completed both study periods according to protocol. There was a significant weight loss and reduction in Hba1c after empagliflozin treatment (table). We found no improvement in CFVR and parameters of cardiac systolic function. We observed a general tendency of reduction in level of cardiovascular biomarkers after empagliflozin treatment (figure) with significant difference between empagliflozin and placebo for 27 proteins, including IL18, ST2, YKL40, ACE2 and leptin. Conclusions Despite a significant weight loss and reduction in Hba1c after empagliflozin treatment, we found no effect on non-endothelial dependent coronary microvascular function in patients with type 2 diabetes mellitus. Improvement in multiple biomarkers may indicate underlying mechanisms but need confirmation in larger studies. Funding Acknowledgement Type of funding sources: Foundation. Main funding source(s): The Danish Council for Independent Research Table 1. Change in outcome parametersFigure 1. Change in biomarker levels

Glycaemic Control in People with Diabetes Starting Treatment with Fast-Acting Insulin Aspart: a US Database Study.

IntroductionThis study investigated glycaemic control in individuals with type 1 (T1D) or type 2 diabetes (T2D) 6 months after initiating fast-acting insulin aspart (faster aspart) in a real-world setting.MethodsThis was a single-arm, observational study using extracted patient data from the IBM® Explorys® database (USA) for individuals with T1D or T2D initiating faster aspart (at least one prescription of faster aspart) in the study period 1 January 2018 to 27 October 2020. Clinical characteristics, including age, body mass index, and baseline HbA1c, were extracted, as well as recorded events of hypoglycaemia. The primary endpoint was the change in HbA1c from baseline to 6 months.ResultsA total of 787 individuals were included; 36.6% of these individuals had T1D and 63.4% had T2D (of whom 46.9% were new users of rapid-acting insulin when initiating faster aspart [T2D new users] and 53.1% were switching from another rapid-acting insulin to faster aspart [T2D switchers]). For individuals with T1D, T2D new users, or T2D switchers, estimated mean change in HbA1c from baseline to 6 months was − 0.20% (95% CI − 0.53, 0.14; p = 0.252), − 1.00% (95% CI − 1.34, − 0.67; p < 0.0001), and − 0.70% (95% CI − 1.06, − 0.35; p = 0.0001), respectively. In the baseline HbA1c > 8.5% subgroup, there was a significant estimated decrease in HbA1c from baseline to 6 months in individuals with T1D (− 1.2% [95% CI − 1.80, − 0.60]; p = 0.0001) or T2D (− 0.6% [95% CI − 0.92, − 0.35]; p < 0.0001). Event rates of hypoglycaemia after 12 months were 0.68, 0.38, and 0.59 events/year for individuals with T1D, T2D new users, and T2D switchers, respectively.ConclusionUS IBM® Explorys® data demonstrated a clinically relevant reduction in HbA1c 6 months after initiating faster aspart treatment for individuals with T2D, but not T1D overall, although patients with baseline HbA1c > 8.5% had significant HbA1c reductions regardless of diabetes type.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-021-01165-0.

Effects of aerobic training and resistance training in reducing cardiovascular disease risk for patients with prediabetes: A multi-center randomized controlled trial

AimsAerobic training (AT) and resistance training (RT) can reduce blood glucose and type 2 diabetes risk, and increase muscle mass for prediabetes patients. However, the impact of long-term AT and RT on cardiovascular disease (CVD) risk remains unclear. The purpose of this study was to investigate the impact of AT and RT on CVD risk reduction in prediabetes patients. Materials and methods248 prediabetes patients were enrolled in this multi-center randomized controlled trial (RCT). Patients were randomly divided into 3 groups: RT (n = 82), aerobic training (AT (n = 83)), and control group (n = 83). Participants in RT and AT groups had moderate RT or AT 3 times a week (150 min/week) under supervision in 3 research centers for 24 months. Primary outcome was CVD risk measured by Framingham Risk Score (FRS) and The Chinese 10-year ischemic cardiovascular disease (ICVD) risk assessment tool. Secondary outcomes included in HOMA2-IR, HbA1c, blood pressure and serum lipid profile. ResultsBoth RT and AT groups experienced a significant reduction in HOMA2-IR, HbA1c, LDL-C, TC, SBP, and DBP at the end of 12 and 24 months. Compared to the control group, Both RT and AT groups had significant reduction of the Chinese 10-year ICVD risk (P < 0.05), but FRS CVD risk declined significantly only in the AT group (all P < 0.05). Although FRS CVD risk decreased more in the RT group than in the control group, the difference was not statistically significant. After adjusting for age, gender, statin use, BMI, and WHR, in COX’s proportional hazard model, RT (HR = 0.419, P = 0.037) and AT (HR = 0.310, P = 0.026) were protective factors for CVD risk in prediabetes patients. 24-month RT and AT decreased respectively 58.1% and 69.0% of CVD risk (10-year ICVD risk assessment) in prediabetes patients. ConclusionsThis study demonstrated that 24-month moderate AT reduces the Chinese 10-year ICVD risk and FRS CVD risk in prediabetes patients. RT groups had significant reduction of CVD risk (10-year ICVD risk assessment) in prediabetes patients. Trial registrationClinical trial registration number: NCT 02561377. Date of registration24/09/2015.

Flash monitor initiation is associated with improvements in HbA1c levels and DKA rates among people with type 1 diabetes in Scotland: a retrospective nationwide observational study

Aims/hypothesisWe assessed the real-world effect of flash monitor (FM) usage on HbA1c levels and diabetic ketoacidosis (DKA) and severe hospitalised hypoglycaemia (SHH) rates among people with type 1 diabetes in Scotland and across sociodemographic strata within this population.MethodsThis study was retrospective, observational and registry based. Using the national diabetes registry, 14,682 individuals using an FM at any point between 2014 and mid-2020 were identified. Within-person change from baseline in HbA1c following FM initiation was modelled using linear mixed models accounting for within-person pre-exposure trajectory. DKA and SHH events were captured through linkage to hospital admission and mortality data. The difference in DKA and SHH rates between FM-exposed and -unexposed person-time was assessed among users, using generalised linear mixed models with a Poisson likelihood. In a sensitivity analysis, we tested whether changes in these outcomes were seen in an age-, sex- and baseline HbA1c-matched sample of non-users over the same time period.ResultsPrevalence of ever-FM use was 45.9% by mid-2020, with large variations by age and socioeconomic status: 64.3% among children aged <13 years vs 32.7% among those aged ≥65 years; and 54.4% vs 36.2% in the least-deprived vs most-deprived quintile. Overall, the median (IQR) within-person change in HbA1c in the year following FM initiation was −2.5 (−9.0, 2.5) mmol/mol (−0.2 [−0.8, 0.2]%). The change varied widely by pre-usage HbA1c: −15.5 (−31.0, −4.0) mmol/mol (−1.4 [−2.8, −0.4]%) in those with HbA1c > 84 mmol/mol [9.8%] and 1.0 (−2.0, 5.5) mmol/mol (0.1 [−0.2, 0.5]%) in those with HbA1c < 54 mmol/mol (7.1%); the corresponding estimated fold change (95% CI) was 0.77 (0.76, 0.78) and 1.08 (1.07, 1.09). Significant reductions in HbA1c were found in all age bands, sexes and socioeconomic strata, and regardless of prior/current pump use, completion of a diabetes education programme or early FM adoption. Variation between the strata of these factors beyond that driven by differing HbA1c at baseline was slight. No change in HbA1c in matched non-users was observed in the same time period (median [IQR] within-person change = 0.5 [−5.0, 5.5] mmol/mol [0.0 (−0.5, 0.5)%]). DKA rates decreased after FM initiation overall and in all strata apart from the adolescents. Estimated overall reduction in DKA event rates (rate ratio) was 0.59 [95% credible interval (CrI) 0.53, 0.64]) after FM vs before FM initiation, accounting for pre-exposure trend. Finally, among those at higher risk for SHH, estimated reduction in event rates was rate ratio 0.25 (95%CrI 0.20, 0.32) after FM vs before FM initiation.Conclusions/interpretationFM initiation is associated with clinically important reductions in HbA1c and striking reduction in DKA rate. Increasing uptake among the socioeconomically disadvantaged offers considerable potential for tightening the current socioeconomic disparities in glycaemia-related outcomes.Graphical abstract

Efficacy and safety of different basal and prandial insulin analogues for the treatment of type 2 diabetes: a network meta-analysis of randomized controlled trials.

The aim of the present network meta-analysis is to assess the efficacy and safety across different long and short-acting analogs for the treatment of type 2 diabetes. A PubMed, EMBASE, and Cochrane Central Register of Controlled Trials databases search (20th May, 2020) for all trials with a duration ≥24 weeks comparing an analogue with another or human insulin was performed. Indirect comparisons were performed by NMA choosing glargine U100 and human regular insulin, as the reference for long- and short-acting analogues, respectively. Primary endpoints were HbA1c at 24, 52, and 104 weeks. The weighted difference in means (WDM) and Mantel-Haenzel Odds Ratio [MH-OR] with 95% Confidence Intervals (CI) were calculated for categorical and continuous variables, respectively. Fifty trials (n = 43) and 7 for basal and prandial analogues, respectively, enrolling 25,554 and 3184 patients with type 2 and 1 diabetes, respectively, were included. At NMA, detemir was less effective than glargine U-100 at 52 weeks. A significant reduction of 24-week HbA1c (WMD [IC]: -0.10 [-0.17, -0.03]%); and risk of total (MH-OR [IC]: 0.80 [0.70, 0.91]), and nocturnal hypoglycemia (MH-OR [IC]: 0.57 [0.45, 0.73]) was observed for basal analogues versus NPH insulin. At NMA, glargine U300 and degludec were associated with a significant reduction in the risk of nocturnal hypoglycemia. No significant differences across different short-acting insulin were observed. This paper supports the use of long-acting analogues, rather than NPH insulin, as basal insulin for the treatment of type 2 diabetes, without any preferences for any individual long-acting analogue over the others. The evidence on short acting analogues is limited.

Impact of Integrated Medication Reminders, Gamification, and Financial Rewards Via Smart Phone Application on Treatment Adherence in Uncomplicated Type II Diabetes Patients

Background: Poor medication adherence in type 2 diabetes mellitus (T2DM) leads to poor glycemic control. Materials and Methods: This randomized, open-labeled, controlled study recruited consenting adult patients with uncomplicated T2DM who were on daily oral antidiabetics with documented poor medication adherence (missing ≥20% of their prescribed doses in the past 15 days). Patients in the “incentive group” installed a digital therapeutics mobile app (KYT-Adhere) and received multiple daily medication reminders. Patients were asked to show the pill/(s) to the app before consuming the medication, after which the patients received “KYT-Points”; these would be converted into financial incentives after 3 months, provided that they maintained ≥80% medication adherence. These patients received incentives for 3 months and medication reminders for 6 months. “Control group” patients received standard care. Results: A total of 118/120 recruited patients completed the study; 59 each with similar baseline parameters were randomized to incentive and control groups. At baseline, medication adherence and HbA1c were comparable (adherence: 65.7±4.7% and 65.3±4.0%; HbA1c: 9.0±0.3% and 9.0±0.3% for incentive and control groups, respectively). Over the study duration, the incentive group showed a significant improvement in medication adherence (P &lt; 0.001) and significant HbA1c reduction (P &lt; 0.001). At study closure, the average medication adherence and HbA1c were significantly different between the two groups (adherence: 86.8±3.2% vs. 67.7±4.6%, P &lt; 0.001; HbA1c: 7.3±0.2% vs. 8.2±0.3%, P &lt; 0.001). Conclusion: Gamification through combining repeated medication reminders and rewards through a smartphone application brought about a behavioral change, which improved medication adherence and glycemic control among T2DM patients within 3 months and was sustained for 3 more months without rewards.

Structured self-monitoring of blood glucose is associated with more appropriate therapeutic interventions than unstructured self-monitoring: A novel analysis of data from the PRISMA trial

AimsTo investigate the relationship between single therapeutic interventions and indicatorsofglycemic control in the PRISMA trial, a large study comparing the effects of intensive structured SMBG (ISM) vs. active control (AC) in non-insulin-treated type 2 diabetes (T2D). MethodsInformation was collected at four time points, corresponding to months 3, 6, 9, and 12 and visits 2, 3, 4, and 5, respectively. Data on therapeutic interventions, HbA1c levels and the number of hypoglycemic episodes at each visit were analyzed. ResultsIntensification of drug therapy occurred in 20.3% vs. 15.6%, and no change in 71.8% vs. 78.7% of visits for the ISM and AC groups, respectively. On the other hand, de-intensification and redistribution of drugs and/or drug dose occurred in a similar proportion of visits. Intensification of drug therapy in both groups was associated with significant reductions in HbA1c vs. the previous visit, while de-intensification of therapy led to a significant increase in HbA1c in the AC group only. Conclusions. Our data strongly support that structured SMBG has clinical value in reducing HbA1c in non-insulin-treated T2D and suggest that this clinical benefit may be mediated by more appropriate and timely changes in drug therapy.

Retrospective, observational study on usage of evogliptin in T2DM patients: A real-World experience in Indian patients

This study aimed to assess effectiveness and safety of Evogliptin 5 mg in patients with T2DM who were prescribed Evogliptin alone or with other oral hypoglycemic agents in real world scenario. Overall 20 patients who received Evogliptin as routine clinical practice in management of T2DM were analyzed retrospectively from single center. Data collected from past medical records. Primary endpoint was mean changes in HbA1c from baseline to weeks 24 and secondary endpoints were Change in HbA1c from baseline to weeks 12 Change from baseline in FPG &amp; PPG at weeks 12 &amp; 24.Significant reduction in HbA1c at the end of 12 and 24 weeks of Evogliptin therapy was - 0.9% and -1.45% respectively from the baseline of HbA1c 8.6% (p value &amp;#60;0.001). At the end of 12 and 24 weeks of addition of Evogliptin, significant reduction in FBG were seen i.e -49.5 mg/dl and -90.7mg/dl respectively from base line of 182 mg/dl and reduction in PPG was -79.4mg/dl and -116.6mg/dl respectively from base line 277 mg/dl (p value &amp;#60;0.001). Evogliptin was found to be effective when added to the patients who were uncontrolled on dual / triple oral anti-diabetic medications and even in treatment naïve patient. It effectively showed reduction in HbA1c, FBG and PPG and the end of 12 and 24 weeks when added to existing anti-diabetic medications &amp; well tolerated in type 2 diabetes Indian patients.Small sample size and retrospective study

Real-World Clinical Outcomes Associated with Canagliflozin in Patients Aged 65 Years and Older with Type 2 Diabetes Mellitus in Spain: The Old Real-Wecan Study

The observational Real-Wecan study showed that canagliflozin 100 mg (CANA100) as an add-on therapy, and canagliflozin 300 (CANA300), switching from prior SGLT-2i therapy, significantly improved several cardiometabolic parameters in patients with T2DM. The aim of this sub-analysis was to assess the effectiveness and safety of canagliflozin in patients aged ≥65 years. The primary outcome of the study was the mean change in HbA1c over the follow-up period. A total of 583 patients met the inclusion criteria (39.5% ≥65 years), 279 in the cohort of CANA100 (36.9% ≥65 years; mean HbA1c 8.05%) and 304 in the cohort of CANA300 (mean age 61.1 years; 41.8% ≥65 years; mean HbA1c 7.51%). In the CANA100 cohort, older patients showed significant reductions in HbA1c (−0.78%) and weight (−4.5 kg). Patients aged ≥65 years switching to CANA300 experienced a significant decrease in HbA1c (−0.27%) and weight (−2.1 kg). There were no significant differences in HbA1c and weight reductions when the cohorts of patients &lt;65 and ≥65 years were compared in a multiple linear regression model. The safety profile of canagliflozin was similar in both age groups. These findings support canagliflozin as an effective therapeutic option for older adults with T2DM.

The cardiovascular‐protective properties of saffron and its potential pharmaceutical applications: A critical appraisal of the literature

Saffron, the dried stigma of Crocus sativus L., is used in traditional medicine for its healing properties and the treatment of various pathological conditions. The present literature review aimed to summarize and evaluate the preclinical and clinical data regarding the protective effects and mechanisms of saffron and its main components (crocin, crocetin, safranal) on cardiovascular risk factors and diseases. Many in vitro and animal studies have been conducted implicating antioxidant, hypolipidemic, anti-diabetic, and antiinflammatory impact of saffron and its constituents. Notably, there is evidence of direct atherosclerosis regression and stabilization in valid atherosclerosis-prone animal models. However, current clinical trials have shown mostly weak effects of saffron and its constituents on cardiovascular risk factors: (a) Modest lowering of fasting blood glucose, without significant reduction of HbA1c in type 2 diabetic patients, (b) moderate/controversial hypolipidemic effects, (c) negligible hypotensive effect, and (d) inconsistent modification of metabolic syndrome parameters. There are important drawbacks in clinical trial design, including the absence of pharmacokinetic/pharmacodynamic tests, the wide variance of doses and cohorts' characteristics, the small number of patients, the short duration. Therefore, large, properly designed, high-quality clinical trials, focusing on specific conditions are required to evaluate the biological/pharmacological activities and firmly establish the clinical efficacy of saffron and its possible therapeutic uses in cardiovascular diseases.

Effectiveness of a ketogenic diet and virtual coaching intervention for patients with diabetes: A difference-in-differences analysis.

To test the effectiveness of a ketogenic diet and virtual coaching intervention in controlling markers of diabetes care and healthcare utilization. Using a difference-in-differences analysis with a waiting list control group-a quasi-experimental methodology-we estimated the 5-month change in HbA1c, body mass index, blood pressure, prescription medication use and costs, as well as healthcare utilization. The analysis included 590 patients with diabetes who were also overweight or obese, and who regularly utilize the Veterans Health Administration (VA) for healthcare. We used data from VA electronic health records from 2018 to 2020. The ketogenic diet and virtual coaching intervention was associated with significant reductions in HbA1c (-0.69 [95% CI -1.02, -0.36]), diabetes medication fills (-0.38, [-0.49, -0.26]), body mass index (-1.07, [-1.95, -0.19]), diastolic blood pressure levels (-1.43, [-2.72, -0.14]), outpatient visits (-0.36, [-0.70, -0.02]) and prescription drug costs (-34.54 [-48.56, -20.53]). We found no significant change in emergency department visits (-0.02 [-0.05, 0.01]) or inpatient admissions (-0.01 [-0.02, 0.01]). This real-world assessment of a virtual coaching and diet programme shows that such an intervention offers short-term benefits on markers of diabetes care and healthcare utilization in patients with diabetes.

Hybrid Closed-loop to Manage Gastroparesis in People With Type 1 Diabetes: a Case Series.

Background:Gastroparesis is associated with unpredictable gastric emptying and can lead to erratic glucose profiles and negative impacts on quality-of-life. Many people with gastroparesis are unable to meet glycemic targets and there is a need for new approaches for this population. Hybrid closed-loop systems improve glucose control and quality-of-life but evidence for their use in people with diabetic gastroparesis is limited.Methods:We present a narrative review of the challenges associated with type 1 diabetes management for people with gastroparesis and present a case series of 7 people with type 1 diabetes and gastroparesis. We compare glycemic control before and during the first 12 months of hybrid closed-loop therapy. Data were analyzed using electronic patient records and glucose management platforms. We also discuss future advancements for closed-loop systems that may benefit this population.Results:Five of 7 patients had data available for time in range before and during hybrid closed-loop therapy, and all had an improvement in percentage time in target glucose range, with the overall mean time in range increasing from 26.0% ± 15.7% to 58.4% ± 8.6% during HCL use, (P = .004). There were significant reductions in HbA1c (83 ± 9 mmol/mol to 71 ± 14 mmol/mol) and mean glucose from 13.0 ± 1.7 mmol/L (234 ± 31 mg/dL) to 10.0 ± 0.7 mmol/L (180 ± 13 mg/dL) with use of a hybrid closed-loop system. Importantly, this was achieved without an increase in time in hypoglycemia (P = .50).Conclusion:Hybrid closed-loop systems may represent a valuable approach to improve glycemic control for people with type 1 diabetes and gastroparesis. Prospective studies are required to confirm these findings.

A Pilot Study of Intervention With a Mobile Application Visualizing the Macronutrient Content for Type 2 Diabetes at a Japanese Center.

BackgroundEstimating the nutritional content of food is essential for self-management in people with type 2 diabetes mellitus, but it is a difficult skill to learn. The aim of this study was to investigate how diabetes management was impacted by the ability of patients to search for items they ate from a database of 26,300 different foods, and to visualize nutritional intake using the Japanese mobile application (app) “Calomeal.”MethodsThis was a single-arm, single-center, pilot study. Eighteen outpatients with type 2 diabetes mellitus used the “Calomeal” app for 3 months. The primary endpoint was change in hemoglobin A1c (HbA1c). Secondary endpoints were changes in body weight (BW), lipid parameters, and quality of life scores.ResultsThe baseline characteristics of the study subjects were as follows: age: 53.4 ± 7.8 years; male/female ratio: 11/7; HbA1c: 7.9 (7.58 - 8.23)%; and body mass index (BMI): 25.17 (21.63 - 28.59) kg/m2. Significant reductions in HbA1c and BMI were observed over 3 months (HbA1c: 7.9 (7.58 - 8.23)% to 7.6 (7.3 - 8.23)%, P = 0.0410; BMI: 25.17 (21.63 - 28.59) to 24.54 (21.57 - 27.81) kg/m2, P = 0.0057). Reductions in HbA1c and BMI both correlated with decreased carbohydrate intake estimated by the mobile app.ConclusionsJapanese patients who used their smartphones to visualize their nutritional intake using the “Calomeal” app demonstrated improved short-term glycemic control and BMI. Although the validity of the results should be tested in future randomized controlled trials, this approach may be a clinical option for improving self-management in Japanese patients with type 2 diabetes mellitus.

Mentored implementation to initiate a diabetes program in an underserved community: a pilot study

IntroductionCommunity clinics often face pragmatic barriers, hindering program initiation and replication of controlled research trial results. Mentoring is a potential strategy to overcome these barriers. We piloted an in-person and...

A Personalized Mobile Health Program for Type 2 Diabetes During the COVID-19 Pandemic: Single-Group Pre–Post Study

BackgroundWith increasing type 2 diabetes prevalence, there is a need for effective programs that support diabetes management and improve type 2 diabetes outcomes. Mobile health (mHealth) interventions have shown promising results. With advances in wearable sensors and improved integration, mHealth programs could become more accessible and personalized.ObjectiveThe study aimed to evaluate the feasibility, acceptability, and effectiveness of a personalized mHealth-anchored intervention program in improving glycemic control and enhancing care experience in diabetes management. The program was coincidentally implemented during the national-level lockdown for COVID-19 in Singapore, allowing for a timely study of the use of mHealth for chronic disease management.MethodsPatients with type 2 diabetes or prediabetes were enrolled from the Singapore Armed Forces and offered a 3-month intervention program in addition to the usual care they received. The program was standardized to include (1) in-person initial consultation with a clinical dietitian; (2) in-person review with a diabetes specialist doctor; (3) 1 continuous glucose monitoring device; (4) access to the mobile app for dietary intake and physical activity tracking, and communication via messaging with the dietitian and doctor; and (5) context-sensitive digital health coaching over the mobile app. Medical support was rendered to the patients on an as-needed basis when they required advice on adjustment of medications. Measurements of weight, height, and glycated hemoglobin A1c (HbA1c) were conducted at 2 in-person visits at the start and end of the program. At the end of the program, patients were asked to complete a short acceptability feedback survey to understand the motivation for joining the program, their satisfaction, and suggestions for improvement.ResultsOver a 4-week recruitment period, 130 individuals were screened, the enrollment target of 30 patients was met, and 21 patients completed the program and were included in the final analyses; 9 patients were lost to follow-up (full data were not available for the final analyses). There were no differences in the baseline characteristics between patients who were included and excluded from the final analyses (age category: P=.23; gender: P=.21; ethnicity: P>.99; diabetes status category: P=.52, medication adjustment category: P=.65; HbA1c category: P=.69; BMI: P>.99). The 21 patients who completed the study rated a mean of 9.0 out of 10 on the Likert scale for both satisfaction questions. For the Yes-No question on benefit of the program, all of the patients selected “Yes.” Mean HbA1c decreased from 7.6% to 7.0% (P=.004). There were no severe hypoglycemia events (glucose level <3.0 mmol/L) reported. Mean weight decreased from 76.8 kg to 73.9 kg (P<.001), a mean decrease of 3.5% from baseline weight. Mean BMI decreased from 27.8 kg/m2 to 26.7 kg/m2 (P<.001).ConclusionsThe personalized mHealth program was feasible, acceptable, and produced significant reductions in HbA1c (P=.004) and body weight (P<.001) in individuals with type 2 diabetes. Such mHealth programs could overcome challenges posed to chronic disease management by COVID-19, including disruptions to in-person health care access.

Effects of Melissa officinalis L. (Lemon Balm) Extract Supplementation on Cardiovascular Risk Factors: A Pooled Analysis of Randomized Controlled Trials

Several clinical trials have investigated the effects of Melissa officinalis (lemon balm) on cardiovascular risk factors, but have yielded conflicting results and had only modest sample sizes. The aim of this pool analysis was to summarize the evidence of the effects of Melissa officinalis supplementation on plasma lipid profiles, body weight, blood pressure and glucose levels. Original randomized controlled trials (RCTs) that assessed the clinical effects of Melissa officinalis consumption in human participants and published before June 2020 were identified by searching online databases, including PubMed, Scopus, Web of Science and Google Scholar databases. The quality of trials was assessed using the Cochrane Risk of Bias Tool. Quantitative data analysis was performed using weighed mean difference (WMD) and 95% confidence interval (CI) as summary statistics. Standard methods for assessing statistical heterogeneity and publication bias were used, respectively. Four trials with 244 participants were included in the final analysis. Pooling of results showed that Melissa officinalis significantly lowered total cholesterol (TC) (WMD, -7.55 mg/dL; 95% CI -14.99, -0.12; P=0.045), low-density lipoprotein cholesterol (LDL-C) (WMD, -11.33 mg/dL; 95% CI -19.46, -3.21; P=0.006), glycated hemoglobin (HbA1c) (WMD, -0.35 %; 95% CI -0.64, -0.07; P=0.01), and Systolic blood pressure (SBP) (WMD, -0.89 mmHg; 95% CI-1.69, -0.09; P=0.03). The use of Melissa officinalis did not appear to significantly alter any other study endpoints. The present findings showed that supplementation with Melissa officinalis extract were associated with a significant reduction in TC, LDL-C, HbA1c, and SBP in humans.

The Impact of COVID-19 Lockdown on Metabolic Control and Access to Healthcare in People with Diabetes: the CONFI-DIAB Cross-Sectional Study.

IntroductionThe COVID-19 pandemic led to an international health crisis and restrictions. While the phenotype associated with COVID-19 severity in people with diabetes has rapidly been explored, the impact of restrictive measures, including lockdown, and tertiary care disruption on metabolic control and access to healthcare remained unknown. The aim of our study was to provide a comprehensive assessment on the overall management of diabetes during lockdown, including glucose control, weight changes, health care consumption and use of alternative forms of care such as telemedicine services, in a large sample of patients with type 1 (T1DM) or type 2 diabetes mellitus (T2DM).MethodsA prioritization of a care self-administered questionnaire was sent at the end of the first COVID-19 lockdown to all patients with diabetes routinely followed by diabetologists from the University Hospital of Nancy (France). This observational cross-sectional single-center study focused on data from patients with diabetes who returned the questionnaire along with medical records. The primary outcome was the change in HbA1c levels between the 6 months preceding and the 6 weeks following the lockdown. Data are expressed as numbers (%) or medians (quartiles). This study is registered with ClinicalTrials.gov (NCT04485351).ResultsWe analyzed data from 870 patients with diabetes: 549 T2DM (63.1%), 520 males (59.8%), age 65.0 (57.0, 72.0), body mass index 28.6 (25.1, 32.9) and diabetes duration 20.0 (10.0, 30.0) years. HbA1c levels pre- and post-lockdown were respectively 7.7% (7.1, 8.4) and 7.4% (6.8, 8.2), translating into a significant reduction of − 0.1% (− 0.6, 0.15) (p < 0.0001). Stratified analyses suggested a consistent significant reduction of HbA1c independently of diabetes type. HbA1c reduction was significantly different according to weight changes: − 0.3% (− 0.8, 0.0), − 0.1% (− 0.5, 0.1) and − 0.1% (− 0.5, 0.3) for patients who lost, had stable or gained weight, respectively (p = 0.0029). Respectively, 423 (49.4%) and 790 (92.3%) patients did not consult their general practitioner and diabetologist. Blood tests were undergone by 379 (44.8%) patients, 673 (78.3%) did refill their prescriptions, and 269 (32.1%) used teleconsultation services.ConclusionsDespite the implementation of a lockdown and disruption in healthcare, no deterioration, rather an improvement, in metabolic control was observed in a large sample of patients with T1DM and T2DM.

SHORT TERM EFFECT OF LAPAROSCOPIC SLEEVE GASTRECTOMY ON TYPE 2 DIABETIC MORBID OBESE PATIENTS

Background: Obesity is a medical condition in which excess body fat has accumulated to extend that it may has an adverse effect on health. Leading to reduction of life expectancy or increasing health problems. Objective: To evaluate the improvement in plasma glucose level and lipid profile in type 2 diabetes mellitus obese patients after Laparoscopic Sleeve Gastrectomy (LSG). Patients and methods: This prospective study was conducted at Surgery Department, Al-Azhar University Hospitals during the period between December 2019 and August 2020. Study included 30 cases of type 2 diabetes mellitus morbidly obese patients (with BMI ≥35 Kg/m²) and all of them had failed in trials of conservative management including dietary control, and they were bulky eater but non sweet eater. Laparoscopic sleeve gastrectomy technique was done for all cases. Results: Our result showed that there was a significant improvement of the HbA1c measured at three and six months post-operatively. Five patients (17%) completely cured from T2DM, while 12 patients (40%) became pre-diabetic, and 13 patients (43%) remained diabetic with great improvement of their previous follow up of HbA1c. Conclusion: LSG was efficient in the remission and/or improvement of symptoms of T2DM and other obesity-related comorbidities, with a significant reduction in serum HbA1c and lipid profile.

High-dose sodium-glucose co-transporter-2 inhibitors are superior in type 2 diabetes: A meta-analysis of randomized clinical trials.

To determine the overall efficacy of high- versus low-dose sodium-glucose co-transporter-2 (SGLT2) inhibitors in patients with type 2 diabetes (T2D). A literature search using MEDLINE, EMBASE and the Cochrane Library was performed from 1 January 2006 to 23 September 2020. Random effects models were used to calculate mean differences (MDs) and pooled relative risk (RR). Prespecified subgroup analyses for each SGLT2 inhibitor, follow-up and controls were performed. Leave-one-out sensitivity and meta-regression analyses were conducted. A total of 51 randomized controlled trials involving 23 989 participants (weighted mean age, 58.9 years; men, 58.8%) were eligible for our meta-analysis. For glycaemic regulation ability, a significant reduction in HbA1c (MD -0.080%, 95% confidence interval [CI] -0.100 to -0.060), fasting plasma glucose (MD -0.227 mmol/L, 95% CI -0.282 to -0.173) and postprandial plasma glucose (MD -0.834 mmol/L, 95% CI -1.268 to -0.400) levels was observed in the high-dose SGLT2 inhibitor group. Treatment with high-dose SGLT2 inhibitors enabled easier achievement of the target (HbA1c <7%) than low-dose SGLT2 inhibitors (RR 1.148, 95% CI 1.104 to 1.193). High-dose SGLT2 inhibitor-based treatment resulted in more efficient regulation of body weight and blood pressure (body weight: MD -0.346 kg, 95% CI -0.437 to -0.254; systolic blood pressure: MD -0.583 mmHg, 95% CI -0.903 to -0.263; diastolic blood pressure: MD -0.352 mmHg, 95% CI -0.563 to -0.142). The results were similar in sensitivity analyses. The overall efficacy of SGLT2 inhibitors, mainly canagliflozin, dapagliflozin and empagliflozin, was found to be dose dependent.