Mean Glycated Hemoglobin Level Research Articles

Comparison of various prediction models in the effect of Roux-en-Y gastric bypass on type 2 diabetes in the Chinese population 5 years after surgery.

Various prediction models of type 2 diabetes (T2D) remission have been externally verified internationally. However, long-term validated results after Roux-en-Y gastric bypass (RYGB) surgery are lacking. The best model for the Chinese population is also unknown. To evaluate the prediction effect of various prediction models on the long-term diabetes remission after RYGB in the Chinese population and to provide reference for clinical use. A retrospective clinical study at a university hospital. We retrospectively analyzed Chinese population data 5 years after RYGB and externally validated 11 predictive models to evaluate the predictive effect of each model on long-term T2D remission after RYGB. We enrolled 84 patients. The mean body mass index was 41 kg/m2, and the percentage of excess weight loss (%EWL) was 72.3%. The mean glycated hemoglobin level was 8.4% preoperatively and decreased to 5.9% after 5 years. The 5-year postoperative complete and partial remission rates of T2D were 31% and 70.2%, respectively. The ABCD scoring model (sensitivity, 84%; specificity, 76%; area under the curve [AUC], .866) and the Panuzi etal. [34] study (sensitivity, 84%; specificity, 81%; AUC, .842) showed excellent results. In the Hosmer-Lemeshow goodness-of-fit test, calibration values for ABCD and Panuzi etal. [34] were .14 and .21, respectively. The predicted-to-observed ratios of ABCD and Panuzi etal. [34] were .83 and .88, respectively. T2D was relieved to varying degrees 5 years after RYGB in patients with obesity. Theprediction models in ABCD and the Panuzi etal. [34] studies showed the best prediction effects. ABCD was recommended for clinical use because of excellent predictive performance, goodstatistical test results, and simple and practical design features.

Ankle-brachial Index as Predictor of Coronary Artery Disease in Diabetic Patients

Introduction: In India, the incidence of coronary artery disease (CAD) has doubled, and the association between diabetes mellitus, peripheral arterial disease, and CAD remains unclear. This study aimed to explore the relationship between ankle-brachial index (ABI) and CAD in diabetic patients, using the ABI as a diagnostic tool for peripheral arterial disease. Materials and Methods: A cross-sectional study at a tertiary care center analyzed 100 diabetes cases for CAD using angina history, past treatment, electrocardiography, and two-dimensional echocardiography. Blood pressure was measured in all limbs, and ABI was calculated by dividing ankle pressure by brachial pressure, selecting the lower ratio. Results: Out of 100 patients, 28 had ABI <0.9 and 72 had ABI ≥0.9. The majority of both groups were male. The highest percentage in both groups was aged 51–60. The ABI +VE group had higher proportions of hypertension, smokers, and dyslipidemia. The majority in the ABI −VE group were nonsmokers and without dyslipidemia. Both groups had a majority with body mass index ≥25 kg/m2. Mean diabetes duration was higher in the ABI +VE group, while mean glycated hemoglobin levels were higher in the ABI −VE group. Conclusion: In our study, the prevalence of ABI +VE patients was 28% and prevalence of CAD in this group was 42.85%, which is statistically significant. Hypertension, smoking, dyslipidemia, diabetes duration, and glycemic control were significantly associated with low ABI index (ABI <0.9).

Assessment of selected muscle damage markers and zonulin concentration after maximum-intensity exercise in men with type 1 diabetes treated with a personal insulin pump

AimExercise-induced muscle damage depends on exercise intensity and duration and on individual susceptibility. Mechanical and metabolic stress may disturb the intestinal microflora. The study evaluated selected muscle damage markers and zonulin concentration after maximum-intensity exercise in type 1 diabetes (T1D) men compared with healthy controls.MethodsThe study involved 16 T1D participants and 28 controls matched by age (22.7 [21.3–25.1] vs. 22.6 [20.9–26.3] years), body mass index (24.2 ± 1.6 vs. 24.2 ± 1.9 kg/m2), and body fat percentage (16.1 ± 5.2 vs. 14.9 ± 4.6%). The T1D group had 11.3 ± 5.1 years of diabetes duration and a suboptimal mean glycated haemoglobin level of 7.2 ± 1.1%. The subjects underwent a graded running treadmill test until exhaustion. Lactate concentration was assessed in arterialized blood at baseline and 3 and 20 min after the test. Cortisol, testosterone, tumour necrosis factor α, myoglobin, lactate dehydrogenase, zonulin, and vitamin D levels were evaluated in cubital fossa vein blood before and 60 min after the test.ResultsT1D patients presented higher baseline zonulin, myoglobin concentration, testosterone/cortisol ratio, and lower maximal oxygen uptake. On adjusting for the baseline values, the groups differed in zonulin, lactate dehydrogenase, and myoglobin levels, testosterone/cortisol ratio, and lactate concentration determined 20 min after exercise (P < 0.05).ConclusionMaximum-intensity exercise increased muscle and intestinal damage in T1D participants. In patients with lower physical activity, very-high-intensity exercise should be recommended with caution. Observing the anabolic-catabolic index may help individualize effort intensity in T1D individuals.

Continuous low serum levels of advanced glycation end products and low risk of cardiovascular disease in patients with poorly controlled type 2 diabetes

BackgroundType 2 diabetes is associated with an increased risk of developing cardiovascular events. Previous studies have reported that advanced glycation end products (AGEs) were related to cardiovascular events in type 2 diabetes. However, data on associations between long-term AGEs and cardiovascular events in type 2 diabetes are lacking. This study aimed to determine whether a long-time shift in the levels of serum AGEs is associated with cardiovascular events in patients with poorly controlled type 2 diabetes.MethodsTwo-time serum methyl-glyoxal-hydroimidazoline (MG-H1) levels were measured in 138 patients with type 2 diabetes whose mean glycated hemoglobin level was 10.1%. We categorized patients whose serum MG-H1 levels were < 2.8 µg/mL at both times as the continuous low MG-H1 group. The primary endpoints of this study were combined cardiovascular events, which were defined as heart disease, peripheral arterial disease, stroke, and all-cause death. Hazard ratios (HRs) for combined cardiovascular events with 95% confidence intervals (CIs) were calculated using the Cox proportional hazard models to compare the outcomes between the continuous low MG-H1 group and others.ResultsThe continuous low MG-H1 group was associated with a significantly lower risk than others in combined cardiovascular events after adjusting for possible confounders (HR: 0.50; 95% CI, 0.28–0.87; P = 0.02). Furthermore, the same relationship was observed in patients without a history of cardiovascular events.ConclusionsContinuous low serum MG-H1 levels are associated with a low frequency of diabetes-related complications in patients with poorly controlled type 2 diabetes.

Evaluation of Psychological Resources of Young Adults With Type 1 Diabetes Mellitus During the Transition From Pediatric to Adult Diabetes Clinics: Multicenter Cross-sectional Study.

The transition period of patients with type 1 diabetes from pediatric to adult-oriented health care is associated with poorer glycemic control and less frequent clinic attendance. Fears and anxiety about the unknown, care approach differences in adult settings, and sadness about leaving the pediatric provider all contribute to a patient's reluctance to transition. This study aimed to evaluate the psychological parameters of young patients with type 1 diabetes transitioning to an adult outpatient clinic during the first visit. We examined 50 consecutive patients (n=28, 56% female) transitioning from March 2, 2021, to November 21, 2022, into adult care (3 diabetes centers from 3 regions in southern Poland: A, n=16; B, n=21; and C, n=13) and their basic demographic information. They completed the following psychological questionnaires: State-Trait Anxiety Inventory (STAI), Generalized Self-Efficacy Scale, Perceived Stress Scale, Satisfaction with Life Scale, Acceptance of Illness Scale, Multidimensional Health Locus of Control Scale Form C, Courtauld Emotional Control Scale, and Quality of Life Questionnaire Diabetes. We compared their data with those for the general healthy population and patients with diabetes from Polish Test Laboratory validation studies. During the first adult outpatient visit, patients' mean age was 19.2 (SD 1.4) years, with a diabetes duration of 9.8 (SD 4.3) years and BMI of 23.5 (SD 3.1) kg/m2. Patients came from diverse socioeconomic backgrounds: 36% (n=18) live in villages, 26% (n=13) live in towns with ≤100,000 inhabitants, and 38% (n=19) live in bigger cities. Regarding therapy type, 68% (n=34) were treated with insulin pump therapy, whereas 32% (n=16) were treated with multiple daily injections. Patients from center A had a mean glycated hemoglobin level of 7.5% (SD 1.2%). There was no difference regarding the level of life satisfaction, perceived level of stress, and state anxiety between the patients and reference populations. Patients had similar health locus of control and negative emotions control to the general population of patients with diabetes. Most patients (n=31, 62%) believe that control over their health depends on themselves, whereas 52% (n=26) believe that it depends mostly on others. Patients had higher levels of suppression of negative emotions-anger, depression, and anxiety-than the age-matched general population. Additionally, the patients were characterized by a higher acceptance of illness and higher level of self-efficacy compared to the reference populations: 64% (n=32) had a high level of self-efficacy and 26% (n=13) had a high level of life satisfaction. This study indicated that young patients transitioning to adult outpatient clinics have good psychological resources and coping mechanisms, which might result in adequate adaptation and adult life satisfaction including future metabolic control. These result also disprove the stereotypes that young people with chronic disease have worse life perspectives when entering adulthood.

Sleep duration and food intake in people with type 2 diabetes mellitus and factors affecting confectionery intake.

We carried out a cross-sectional study of people with type 2 diabetes mellitus to elucidate the association between sleep duration and food intake. Overall, 2,887 participants with type 2 diabetes mellitus (mean age 63.0 years; 61.1% men; mean glycated hemoglobin level 7.5%) were included in this study. The participants' self-reported dietary habits and sleep duration were evaluated using a brief self-administered dietary history questionnaire and Pittsburgh Sleep Quality Index, respectively. The participants were categorized into thefollowing four groups based on sleep duration: <6, 6-6.9, 7-7.9 (reference) and ≥8 h. No significant differences were observed between the groups regarding energy intake (kcal/day), absolute intake (g/day) or relative intake (% energy) of carbohydrates, total fat, proteins and fibers. However, confectionery intake was higher in the <6 h group and lower in the ≥8 h group than in the reference group after adjustment for confounding factors. In multivariate analysis, sleep durations <6 h and ≥8 h significantly correlated with increased (95% confidence interval 0.55 to 3.6; P= 0.0078) and decreased (95% confidence interval -4.0 to -0.32; P=0.021) confectionery intake, respectively. Confectionery intake was positively correlated with female sex, glycated hemoglobin level and dyslipidemia, whereas it was negatively correlated with alcohol consumption and current smoking status. Short sleep duration is associated with high confectionery intake in people with type 2 diabetes mellitus; this might disturb their glycemic control. Therefore, short sleepers with type 2 diabetes mellitus could improve their glycemic control by avoiding confectionery intake and maintaining adequate sleep duration.

Influence of prior internist encounter on glycaemic control among patients with type 2 diabetes mellitus at a family practice setting in Nigeria.

The huge global diabetes burden and the paucity of diabetes specialists make primary care physicians important stakeholders in controlling diabetes. Hence, we examined the predictors of glycaemic control among primary care patients with type 2 diabetes mellitus (T2DM), highlighting the influence of prior internist encounters during the preceding year on glycaemic control. This questionnaire-based cross-sectional study involved 276 T2DM patients systematically recruited from attendees of a general outpatient clinic (GOPC) in Kano, Nigeria. Data regarding their sociodemographic, clinical and internist encounter and GOPC visit characteristics were collected. Data were subjected to descriptive and inferential statistical analysis. Most participants (56.5%) were females; their mean age was 57.7 ± 9.6 years, mean glycated haemoglobin level was 7.3 ± 1.9%. Age, educational level, ethnicity, insurance status, current blood pressure (BP), treatment type, medication adherence, awareness of the importance of diet in DM control, specialist diabetic clinic visited, number of GOPC visits and prior encounter with an internist in the preceding year were associated with glycaemic control after bivariate analysis (P < 0.05). On multivariate regression, low education, retirees, being self-employed, uninsured, overweight, having optimal BP, using metformin alone, sulphonylurea-metformin and insulin-based treatments and prior encounter with the internist in the preceding year were predictors of optimal glycaemic control. There are multiple predictors of glycaemic control in this setting. These predictors should be considered in glycaemic control risk stratification towards quality individualised care, which includes establishing referral protocols to available specialists. Regular training of primary care physicians on diabetes care is also required.

Validity and reliability study of Diabetes Fatalism Scale inTurkish patients with type 2 diabetes

Background. Turkey is one of the countries with the highest prevalence of diabetes in Europe, with about one in every seven adults diagnosed with diabetes mellitus. By 2035, Turkey will have the highest number of people with type 2 diabetes in Europe, at almost 12 million. Mortality rates have increased with the increasing prevalence of type 2 diabetes, especially in the younger population, such that half of the deaths come from those under sixty. The beliefs and mental state of patients with chronic illnesses like diabetes can affect disease outcomes and the patients’ self-management. Self-care and diabetes medications are important components in improving the disease outcome, though many studies have shown that these activities can be negatively related to fatalism about the disease state. The aim of this study was to investigate the reliability and validity of the Turkish version of the Diabetes Fatalism Scale (DFS), which was developed by Dr. Leonard Egede. Materials and methods. This was a methodological study. The scales were administered to a total of 139 patients with type 2 diabetes. The content and construct validity of the scale were assessed. The construct validity was evaluated using confirmatory factor analysis, and the reliability was assessed in terms of internal consistency. Results. In terms of the population tested, 54.7% of the participants were men, 73.4% were married, 54% had one additional disease other than diabetes, 18% were high school graduates, the mean age was 50.20±16.82 years, the average duration of diabetes was 19.31±14.25 years, and mean glycated hemoglobin level was 7.06±0.65%. It was found that the Kaiser-Meyer-Olkin (KMO) measure of sampling-size adequacy was 0.770, indicating an adequate size, and the chi-square value was 1078.402. When the fifth item was excluded from the study and the analysis was repeated, the KMO coefficient was 0.802 and the chi-square value was 1020.244, p=0.000. The Cronbach’s alpha value reached 0.806, indicating a good internal consistency. The Cronbach’s alpha values of the other subscales also seemed to be at a very good level. Conclusions. Our study showed that the DFS is a valid and reliable scale for the Turkish society. DFS-T is a suitable scale for health professionals to use to assess diabetes fatalism in adults with diabetes in Turkey.

Closed-Loop Therapy and Preservation of C-Peptide Secretion in Type 1 Diabetes

BackgroundWhether improved glucose control with hybrid closed-loop therapy can preserve C-peptide secretion as compared with standard insulin therapy in persons with new-onset type 1 diabetes is unclear.MethodsIn a multicenter, open-label, parallel-group, randomized trial, we assigned youths 10.0 to 16.9 years of age within 21 days after a diagnosis of type 1 diabetes to receive hybrid closed-loop therapy or standard insulin therapy (control) for 24 months. The primary end point was the area under the curve (AUC) for the plasma C-peptide level (after a mixed-meal tolerance test) at 12 months after diagnosis. The analysis was performed on an intention-to-treat basis.ResultsA total of 97 participants (mean [±SD] age, 12±2 years) underwent randomization: 51 were assigned to receive closed-loop therapy and 46 to receive control therapy. The AUC for the C-peptide level at 12 months (primary end point) did not differ significantly between the two groups (geometric mean, 0.35 pmol per milliliter [interquartile range, 0.16 to 0.49] with closed-loop therapy and 0.46 pmol per milliliter [interquartile range, 0.22 to 0.69] with control therapy; mean adjusted difference, −0.06 pmol per milliliter [95% confidence interval {CI}, −0.14 to 0.03]). There was not a substantial between-group difference in the AUC for the C-peptide level at 24 months (geometric mean, 0.18 pmol per milliliter [interquartile range, 0.06 to 0.22] with closed-loop therapy and 0.24 pmol per milliliter [interquartile range, 0.05 to 0.30] with control therapy; mean adjusted difference, −0.04 pmol per milliliter [95% CI, −0.14 to 0.06]). The arithmetic mean glycated hemoglobin level was lower in the closed-loop group than in the control group by 4 mmol per mole (0.4 percentage points; 95% CI, 0 to 8 mmol per mole [0.0 to 0.7 percentage points]) at 12 months and by 11 mmol per mole (1.0 percentage points; 95% CI, 7 to 15 mmol per mole [0.5 to 1.5 percentage points]) at 24 months. Five cases of severe hypoglycemia occurred in the closed-loop group (in 3 participants), and one occurred in the control group; one case of diabetic ketoacidosis occurred in the closed-loop group.ConclusionsIn youths with new-onset type 1 diabetes, intensive glucose control for 24 months did not appear to prevent the decline in residual C-peptide secretion. (Funded by the National Institute for Health and Care Research and others; CLOuD ClinicalTrials.gov number, NCT02871089.)

Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes

BackgroundThe incidence of type 2 diabetes mellitus is increasing among youths. Once-weekly treatment with dulaglutide, a glucagon-like peptide-1 receptor agonist, may have efficacy with regard to glycemic control in youths with type 2 diabetes.MethodsIn a double-blind, placebo-controlled, 26-week trial, we randomly assigned participants (10 to <18 years of age; body-mass index [BMI], >85th percentile) being treated with lifestyle modifications alone or with metformin, with or without basal insulin, in a 1:1:1 ratio to receive once-weekly subcutaneous injections of placebo, dulaglutide at a dose of 0.75 mg, or dulaglutide at a dose of 1.5 mg. Participants were then included in a 26-week open-label extension study in which those who had received placebo began receiving dulaglutide at a weekly dose of 0.75 mg. The primary end point was the change from baseline in the glycated hemoglobin level at 26 weeks. Secondary end points included a glycated hemoglobin level of less than 7.0% and changes from baseline in the fasting glucose concentration and BMI. Safety was also assessed.ResultsA total of 154 participants underwent randomization. At 26 weeks, the mean glycated hemoglobin level had increased in the placebo group (0.6 percentage points) and had decreased in the dulaglutide groups (–0.6 percentage points in the 0.75-mg group and −0.9 percentage points in the 1.5-mg group, P<0.001 for both comparisons vs. placebo). At 26 weeks, a higher percentage of participants in the pooled dulaglutide groups than in the placebo group had a glycated hemoglobin level of less than 7.0% (51% vs. 14%, P<0.001). The fasting glucose concentration increased in the placebo group (17.1 mg per deciliter) and decreased in the pooled dulaglutide groups (−18.9 mg per deciliter, P<0.001), and there were no between-group differences in the change in BMI. The incidence of gastrointestinal adverse events was higher with dulaglutide therapy than with placebo. The safety profile of dulaglutide was consistent with that reported in adults.ConclusionsTreatment with dulaglutide at a once-weekly dose of 0.75 mg or 1.5 mg was superior to placebo in improving glycemic control through 26 weeks among youths with type 2 diabetes who were being treated with or without metformin or basal insulin, without an effect on BMI. (Funded by Eli Lilly; AWARD-PEDS ClinicalTrials.gov number, NCT02963766.)

Characteristics and Treatment Patterns of Patients with Type 2 Diabetes Mellitus in the Middle East and Africa Cohort of the DISCOVER Study Program: a Prospective Study.

IntroductionDespite the high prevalence of type 2 diabetes (T2D) and suboptimal glycemic control in the Middle East and Africa, comprehensive data on the management of T2D remain scarce. The main aim of this study is to describe the characteristics and treatment of patients with T2D initiating second-line glucose-lowering therapy in these regions.MethodsDISCOVER is a global, 3-year, prospective observational study of patients with T2D enrolled at initiation of second-line glucose-lowering therapy. Baseline characteristics and treatments are presented for patients from 12 countries divided into three regions: Mediterranean, Gulf Cooperation Council, and South Africa.ResultsAmong 3525 patients (52.5% male, mean age 54.3 years), mean time since T2D diagnosis was 6.2 years [across-region range (ARR) 5.8–7.5 years] and mean glycated hemoglobin levels were 8.7% (72.0 mmol/mol) [ARR 8.6–9.0% (68–75 mmol/mol)]. At first line, metformin was prescribed for 88.1% (ARR 85.4–90.3%) of patients and a sulfonylurea for 34.4% (ARR 12.7–45.4%). Sulfonylureas and dipeptidyl peptidase-4 inhibitors were prescribed at second line for 55.5% (ARR 48.6–82.5%) and 49.0% (ARR 3.7–73.8%) of patients, respectively. Main reasons for choice of second-line therapy were efficacy (73.2%; ARR 60.1–77.7%) and tolerability (26.8%; ARR 3.7–31.2%).ConclusionsWe demonstrate considerable inter-region variations in the management of T2D, likely affected by multiple factors (health system, physician behavior, and patient compliance), all of which should be addressed to optimize outcomes.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-022-01272-6.

Closed-Loop Insulin Pump Therapy in Young Type 1 Diabetic Children

Source: Ware J, Allen JM, Boughton CK, et al. Randomized trial of closed-loop control in very young children with type 1 diabetes. N Engl J Med. 2022;386:209-219; doi: 10.1056/NEJMoa2111673Investigators from multiple institutions conducted a crossover randomized trial to compare the effectiveness and safety of a closed-loop system (ie, artificial pancreas) to sensor-augmented insulin pump therapy in young children with type 1 diabetes. Participants were children 1-7 years old with a diagnosis of type 1 diabetes for at least 6 months, recruited from diabetes centers in 4 European countries. The closed-loop system consisted of a continuous glucose sensor and insulin pump connected to a smartphone app. The app included an algorithm that automatically adjusted insulin delivery based on real-time sensor glucose readings. With the sensor-augmented pump, insulin therapy was stopped if an algorithm predicted that sensor glucose levels were likely to drop below a specified threshold. Study children were randomized to receive 16 weeks of treatment with the closed loop system, followed by 16 weeks using the augmented-sensor pump, or vice versa. The primary outcome was percentage of time spent in the target glucose range (70 to 170 mg/dL) during each treatment period. Secondary outcomes included percentage of time spent in a hyperglycemic range (>180 mg/dL) and hypoglycemic range (<70 mg/dL) and mean glucose levels. These outcomes were based on readings from the glucose sensors. Glycated hemoglobin levels were measured at baseline and at the end of each treatment period. Differences in outcomes between the closed-loop and sensor-augmented pump treatment period were assessed with repeated-measures linear regression models. Data on adverse events also were collected.Data were analyzed on 74 children with a mean age of 5.6 ±1.6 years. The mean glycated hemoglobin level at baseline was 7.3 ±0.7%. The mean time spent in the target glucose range were 71.6 ±5.9% during the closed-loop period and 62.9 ±9.0% in the sensor-augmented pump period (adjusted difference, 8.7 percentage points; 95% CI, 7.4, 9.9; P <0.001). The median time spent at glucose level >180 mg/dL was significantly less during the closed-loop period than during the control period (22.9% vs 31.7%; adjusted difference, -8.5 percentage points; 95% CI, -.9.9, -7.1; P <0.001); mean sensor glucose levels (145 ±11.8 mg/dL and 158.1 ±18.5 mg/dL, respectively; P <0.001) and mean glycated hemoglobin levels (6.6 ±0.6% and 7.0 ±0.7%) were significantly lower during the closed-loop period than during treatment with the segmented-sensor pump. There was no difference between treatment periods for percentage of time with glucose <70 mg/dL (P = 0.74). One participant had a serious adverse event (severe hypoglycemia) during their closed-loop treatment period.The authors conclude that a closed-loop system improved glycemic control in young children with type 1 diabetes.Dr Fechner has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device.Type 1 diabetes is very difficult to manage in the young child. The therapeutic window for insulin is very narrow, with too much insulin resulting in hypoglycemia and too little insulin resulting in hyperglycemia. The last 5 years have seen tremendous advances in the technology available to children with type 1 diabetes. A 2019 study comparing the insulin pump to multiple daily injections showed that the insulin pump was superior to multiple daily injections. (See AAP Grand Rounds. 2019;42[1]:4.) Continuous glucose monitoring has decreased parental anxiety regarding risk of hypoglycemia and diabetic ketoacidosis;1 however, parents still are responsible for making insulin dose adjustments, and glycemic control overall is not improved.2 The results of a 2020 study of 6- to 13-year-olds with type 1 diabetes demonstrated that glucose levels were in the target range for a longer period of time in those randomized to a closed-loop system than those using a sensor-augmented pump. (See AAP Grand Rounds. 2020;44[6]:69.)3 The current researchers compared a hybrid closed-loop insulin delivery system to sensor-augmented pump therapy in younger children with type I diabetes.The strengths of the current study are the randomized, crossover design using the same algorithm with the closed-loop functionality either abled or disabled; each therapy was 16 weeks, which allowed a meaningful glycated hemoglobin to be obtained. There were no restrictions on previous episodes of hypoglycemia and diabetic ketoacidosis, and the study included a very young children with diabetes, who are more vulnerable to hypo- and hyperglycemia. Weaknesses of this study include underrepresentation of ethnic minorities and a patient population not representative of the typical type 1 diabetes population, as the average glycated hemoglobin level was 7.3% at baseline.4 Decreased patient compliance outside of the confines of a study may be reflected in poorer glucose control regardless of the insulin delivery system used.Hybrid closed-loop insulin therapy in young children with type 1 diabetes has the potential to significantly improve long-term outcomes through improved glycemic control.

Left Ventricular Structure, Tissue Composition, and Aortic Distensibility in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Intervention and Complications

Alterations in myocardial structure, function, tissue composition (e.g., fibrosis) may be associated with metabolic syndrome (MetS). This study aimed to determine the relation of MetS and its individual components to markers of cardiovascular disease in patients with type 1 Diabetes Mellitus (T1DM). A total of 978 subjects of the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications T1DM cohort (age: 49 ± 7 years, 47% female, DM duration 28 ± 5 years) underwent cardiovascular magnetic resonance. In a subset of 200 patients, myocardial tissue composition was measured with cardiovascular magnetic resonance T1 mapping after contrast administration. MetS was defined as T1DM plus 2 other abnormalities based on the American Heart Association/National Cholesterol Education Program criteria. MetS was present in 34.1% of subjects. After adjustment for age, height, scanner, study cohort, gender, smoking, mean glycated hemoglobin levels, history of macroalbuminuria and end-stage renal disease, left ventricle mass was greater by 12.3 g, end-diastolic volume was higher by 5.4 ml, and mass to end-diastolic volume ratio was higher by 5% in patients with MetS versus those without MetS (p <0.001 for all). Myocardial T1 times were lower by 29 ms in patients with MetS than those without (p <0.001). Elevated waist circumference showed the strongest associations with left ventricle mass (+10.1 g), end-diastolic volume (+6.7 ml), and lower myocardial T1 times (+31 ms) in patients with MetS compared with those without (p <0.01). In conclusion, in a large cohort of patients with T1DM, 34.1% of subjects met MetS criteria. MetS was associated with adverse myocardial structural remodeling and change in myocardial tissue composition.

Glycated haemoglobin association with severity of thrombus burden in non-diabetic versus diabetic patients with ST-elevation myocardial infarction.

To determine and compare the relationship between glycated haemoglobin level on admission and the angiographic thrombus burden in diabetic and non-diabetic patients with ST-segment elevation myocardial infarction. The cross-sectional study was conducted at the National Institute of Cardiovascular Diseases, Karachi, from June 2018 to July 2019, and comprised patients presenting with ST-elevation myocardial infarction. Demographic details and self-reported duration of diabetes was recorded. The thrombus burden was assessed on angiography classifying 0 = no thrombus, 1 = possible thrombus, 2 = small thrombus, 3 = moderate thrombus, 4 = large thrombus, and 5 = total occlusion. The data was analysed using SPSS 21. Of the 212 patients, 173(81.6%) were men, and 75(35.4%) had body mass index ≥30kg/m2. The overall mean age of the sample was 54.62±11.75 years. Known diabetic cases were 82(38.7%) and 20(24.4%) were insulin-dependent. Mean glycated haemoglobin level was 7.18±2.03% and 96(45.3%) patients had the critical value >6.5%. Pre-procedure thrombus score in 118(55.7%) patients was 3 and 4 and 57(26.9%) had total occlusion. A significant relationship between glycated haemoglobin level and thrombus score was found in the overall sample as well as in diabetic and non-diabetic groups (p<0.001). Increased glycated haemoglobin level was found to have a positive correlation with thrombus score in both diabetic and non-diabetic patients.

Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes

BackgroundTirzepatide is a dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 (GLP-1) receptor agonist that is under development for the treatment of type 2 diabetes. The efficacy and safety of once-weekly tirzepatide as compared with semaglutide, a selective GLP-1 receptor agonist, are unknown.MethodsIn an open-label, 40-week, phase 3 trial, we randomly assigned 1879 patients, in a 1:1:1:1 ratio, to receive tirzepatide at a dose of 5 mg, 10 mg, or 15 mg or semaglutide at a dose of 1 mg. At baseline, the mean glycated hemoglobin level was 8.28%, the mean age 56.6 years, and the mean weight 93.7 kg. The primary end point was the change in the glycated hemoglobin level from baseline to 40 weeks.ResultsThe estimated mean change from baseline in the glycated hemoglobin level was −2.01 percentage points, −2.24 percentage points, and −2.30 percentage points with 5 mg, 10 mg, and 15 mg of tirzepatide, respectively, and −1.86 percentage points with semaglutide; the estimated differences between the 5-mg, 10-mg, and 15-mg tirzepatide groups and the semaglutide group were −0.15 percentage points (95% confidence interval [CI], −0.28 to −0.03; P=0.02), −0.39 percentage points (95% CI, −0.51 to −0.26; P<0.001), and −0.45 percentage points (95% CI, −0.57 to −0.32; P<0.001), respectively. Tirzepatide at all doses was noninferior and superior to semaglutide. Reductions in body weight were greater with tirzepatide than with semaglutide (least-squares mean estimated treatment difference, −1.9 kg, −3.6 kg, and −5.5 kg, respectively; P<0.001 for all comparisons). The most common adverse events were gastrointestinal and were primarily mild to moderate in severity in the tirzepatide and semaglutide groups (nausea, 17 to 22% and 18%; diarrhea, 13 to 16% and 12%; and vomiting, 6 to 10% and 8%, respectively). Of the patients who received tirzepatide, hypoglycemia (blood glucose level, <54 mg per deciliter) was reported in 0.6% (5-mg group), 0.2% (10-mg group), and 1.7% (15-mg group); hypoglycemia was reported in 0.4% of those who received semaglutide. Serious adverse events were reported in 5 to 7% of the patients who received tirzepatide and in 3% of those who received semaglutide.ConclusionsIn patients with type 2 diabetes, tirzepatide was noninferior and superior to semaglutide with respect to the mean change in the glycated hemoglobin level from baseline to 40 weeks. (Funded by Eli Lilly; SURPASS-2 ClinicalTrials.gov number, NCT03987919.)

Evaluation of Macular and Retinal Nerve Fiber Layer Thickness in Children with Type 1 Diabetes Mellitus without Retinopathy.

PurposeThere are limited data from Asian countries regarding retinal thickness in children with type 1 diabetes mellitus (T1DM). This study aimed to compare the macular and retinal nerve fiber layer (RNFL) parameters between diabetic children without retinopathy and non-diabetic healthy children. We also evaluated the factors associated with RNFL thickness in children with T1DM.MethodsA comparative cross-sectional study was conducted among children with T1DM and healthy children aged 7 to 17 years old in Hospital Universiti Sains Malaysia from 2017 to 2019. Children with retinal disease or glaucoma were excluded. Macular and RNFL thicknesses were measured using spectral-domain optical coherence tomography. Demographic information, duration of diabetes, blood pressure, body mass index, visual acuity, and retinal examination findings were documented. Glycosylated hemoglobin levels, renal function, and blood lipid levels were also collected.ResultsForty-one children with T1DM and 80 age- and sex-matched children were enrolled. Both sexes were affected. Mean duration of diabetes mellitus was 3.66 years. The mean glycated hemoglobin levels in the T1DM group was 9.99%. The mean macular and RNFL thicknesses in children with T1DM were 277.56 (15.82) μm and 98.85 (12.05) μm, respectively. Children with T1DM had a significantly thinner average macula, superior outer macula, nasal outer macula, mean RNFL, and inferior RNFL thickness compared to controls (p < 0.05). There was a significant association between nephropathy and the mean RNFL thickness.ConclusionsChildren with T1DM had significantly decreased mean macular and RNFL thicknesses. Nephropathy is associated with an increased RNFL thickness.

Association of sodium-glucose cotransporter-2 inhibitors with outcomes in type 2 diabetes with reduced and preserved left ventricular ejection fraction: Analysis from the CVD-REAL 2 study.

This study of real‐world data from the Maccabi database in Israel compared the risk of heart failure hospitalization (HHF) or death in patients with type 2 diabetes (T2D) initiating sodium‐glucose cotransporter‐2 (SGLT2) inhibitors versus other glucose‐lowering drugs (OGLDs) according to baseline left ventricular (LV) ejection fraction (EF). After propensity‐matching patients by baseline EF there were 10 614 episodes of treatment initiation; 57% had diabetes for >10 years, the mean glycated haemoglobin level was 66 mmol/mol (8.2%), ∼43% had cardiovascular disease, ∼7% had heart failure and ∼ 20% had chronic kidney disease. A total of 2876 patients (∼9%) had reduced EF (<50%). Over a mean follow‐up of 1.5 years there were 371 HHFs or deaths, 88 (23.7%) in patients with reduced EF. Initiation of SGLT2 inhibitors versus OGLDs was associated with lower risk of HHF or death overall (hazard ratio [HR] 0.57, 95% confidence interval [CI] 0.46‐0.70]; P < 0.001) and in patients with both reduced EF (HR 0.61, 95% CI 0.40‐0.93) and preserved EF (HR 0.55, 95% CI 0.43‐0.70), with no significant heterogeneity (P interaction = 0.72). Our findings from real‐world clinical practice show that the lower risk of HHF and death associated with use of SGLT2 inhibitors versus OGLDs is consistent in T2D patients with both reduced and preserved EF.

Four-Year Screening Interval and Vision-Threatening Retinopathy in Type 2 Diabetes Patients With Good Glycemic Control

ObjectiveTo assess whether vision-threatening retinopathy developed after 4 years in patients with type 2 diabetes with good glycemic control during follow-up. Patients and MethodsUsing data from the Action to Control Cardiovascular Risk in Diabetes and Action to Control Cardiovascular Risk in Diabetes Follow-on studies (conducted from January 1, 2001, to October 14, 2014), we investigated the incidence of vision-threatening retinopathy after 4 years in patients with type 2 diabetes with good or poor glycemic control. Patients with proliferative diabetic retinopathy at baseline were excluded. Vision-threatening retinopathy was defined as severe nonproliferative diabetic retinopathy, proliferative diabetic retinopathy, laser photocoagulation, or vitrectomy. Good and poor glycemic control was defined as mean glycated hemoglobin level less than 7% and 7% or greater during follow-up, respectively. ResultsThis study included 2285 patients. Among patients with no retinopathy at baseline, the 4-year incidence of vision-threatening retinopathy was 0% (0 of 386) and 0.8% (6 of 721) in those with good and poor glycemic control, respectively (P=.54). Similarly, severe retinopathy was not observed at 8 years in patients who did not have retinopathy at 4 years. Among patients with mild to moderate nonproliferative diabetic retinopathy at baseline, the 4-year incidence of vision-threatening retinopathy was significantly higher in those with poor glycemic control than in those with good glycemic control (9.7% [77 of 790] vs 4.4% [13 of 297]; P=.004). Additionally, the remission rate of diabetic retinopathy was low in patients with a long duration of diabetes. Four-year incidences of vision-threatening retinopathy were higher in patients with retinopathy at baseline who had poorer glycemic control and longer durations of diabetes. ConclusionIt may be safe to extend screening intervals for diabetic retinopathy to 4 years or longer in patients with type 2 diabetes with no retinopathy.

Assessment of Effect of Periodontal and Prosthodontic Therapy on Glycemic Control in Patients with Diabetes.

Background:Periodontitis is a chronic inflammatory disease of multifactorial etiology. The present study was conducted to assess the effect of periodontal and prosthodontic therapy on glycemic control in patients with diabetes.Materials and Methods:80 type II diabetics patients of both genders were divided into Group I (periodontal and prosthodontic therapy) and Group II (Healthy). In control group, only oral hygiene instruction and mouth wash were prescribed.Results:Group I had 22 males and 18 females and Group II had 17 males and 23 females. The mean glycated hemoglobin level in Group I was 7.8% before and 6.7% after treatment and in Group II was 6.4% before and 6.2% after treatment. The difference was significant (P < 0.05).Conclusion:There was improvement in glycemic status in diabetic patients undergoing periodontal and prosthodontic therapy as compared to those not undergoing treatment.

Dipeptidyl-Peptidase 4 Inhibitors did not Improve Renal Endpoints in Advanced Diabetic Kidney Disease

The efficacy of dipeptidyl-peptidase 4 inhibitors (DPP4is) in advanced diabetic kidney disease (DKD) is unknown. We investigated whether DPP4is confer renal protective benefits in DKD patients. We conducted a retrospective cohort study between 2012 and 2018 in Taiwan. We only included type 2 diabetes patients with estimated glomerular filtration rate (eGFR) between 30 and 90 mL/min/1.73 m2 and urine albumin to creatinine ratio between 300 and 5,000 mg/g. Patients with DPP4i prescriptions were selected as cases, while non-DPP4i users served as controls. We followed these patients until the presence of composite primary renal endpoints, which was defined by the earliest occur-rence of clinical renal outcomes. A total of 522 patients were included in the analysis, comprising 273 patients with a DPP4i prescription who were selected as cases and 249 patients without DPP4i prescription who were assigned as controls. Median follow-up duration for DPP4i users and nonusers was 2.2 years and 3.4 years, respectively. At baseline, the mean glycated hemoglobin levels for DPP4i users and nonusers were 8.1% and 8.3%, respectively. Among patients with DPP4i prescriptions, there was no reduction in composite primary renal outcome, with a crude hazard ratio (HR) of 1.50 (95% confidence interval [CI], 0.95 to 2.36). Similar results were observed for the risk of persistent eGFR <15 mL/min/1.73 m2, with a HR of 1.68 (95% CI, 0.90 to 3.13), doubling of serum creatinine level, with a HR of 1.05 (95% CI, 0.15 to 7.45), and end-stage renal disease, with a HR of 0.87 (95% CI, 0.14 to 5.19). DPP4i prescription did not reduce the risk of composite renal endpoints in DKD patients. BMI = body mass index; CI = confidence interval; CVOT = cardiovascular outcomes trial; DPP4i = dipeptidyl-peptidase 4 inhibitor; DKD = diabetic kidney disease; eGFR = estimated glomerular filtration rate; ESRD = end-stage renal disease; HbA1c = glycated hemoglobin; HR = hazard ratio; SGLT2i = sodium-glucose cotransporter 2 inhibitor; T2D = type 2 diabetes; UACR = urine albumin to creatinine ratio.