Glycemic Control In Participants Research Articles

Efficacy and safety of once-weekly semaglutide 2·4 mg versus placebo in people with obesity and prediabetes (STEP 10): a randomised, double-blind, placebo-controlled, multicentre phase 3 trial.

There are currently limited data regarding the effect of semaglutide 2·4 mg in individuals with obesity and prediabetes in clinical trials. We aimed to assess the efficacy and safety of semaglutide 2·4 mg for weight management and glycaemic control in participants with obesity and prediabetes. STEP 10 was a randomised, double-blind, parallel-group, phase 3 trial done across 30 trial sites in Canada, Denmark, Finland, Spain, and the UK and included participants aged 18 years or older with a BMI of 30 kg/m2 or higher and prediabetes according to UK National Institute for Health and Care Excellence criteria (defined as having at least one of the following at screening: HbA1c of 6·0-6·4% [42-47 mmol/mol] or fasting plasma glucose [FPG] of 5·5-6·9 mmol/L). Participants were randomly assigned (2:1) to once-weekly subcutaneous semaglutide 2·4 mg or placebo with diet and physical activity counselling for 52 weeks, followed by a 28-week off-treatment period. Primary endpoints were percentage change in bodyweight and proportion of participants reverting to normoglycaemia (HbA1c <6·0% [<42 mmol/mol] and FPG <5·5 mmol/L) at week 52 (assessed in all randomly assigned participants by intention to treat). Selective safety data were collected for participants who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, NCT05040971, and is complete. Between Sept 16 and Dec 29, 2021, 138 participants were randomly assigned to semaglutide 2·4 mg and 69 to placebo. 147 (71%) were female and 60 (29%) were male; 183 (88%) were White. All randomly assigned participants received at least one dose of study drug. Baseline mean age was 53 years (SD 11), bodyweight 111·6 kg (22·2), BMI 40·1 kg/m2 (6·9), waist circumference 120·1 cm (14·7), HbA1c 5·9% (0·3; 41·3 mmol/mol [3·0]), and FPG 5·9 mmol/L (0·6). There was a significantly greater reduction in bodyweight with semaglutide 2·4 mg than with placebo at week 52 (-13·9% [SD 0·7] vs -2·7% [0·6]; estimated treatment difference -11·2% [95% CI -13·0 to -9·4]; p<0·0001). Greater proportions of participants reverted to normoglycaemia at week 52 with semaglutide 2·4 mg than with placebo (103 [81%] of 127 vs nine [14%] of 64; odds ratio 19·8 [95% CI 8·7 to 45·2]; p<0·0001). Serious adverse events occurred in 12 (9%) participants receiving semaglutide 2·4 mg versus six (9%) receiving placebo. Adverse events leading to treatment discontinuation occurred in eight (6%) participants in the semaglutide 2·4 mg group versus one (1%) participant in the placebo group. No new safety signals were reported. Semaglutide 2·4 mg provided superior reduction in bodyweight and reversion to normoglycaemia versus placebo in participants with obesity and prediabetes. The safety and tolerability profile was consistent with previous studies and with the GLP-1 receptor agonist class. These findings support the potential use of semaglutide 2·4 mg as a treatment option for individuals with obesity and prediabetes to achieve reversion to normoglycaemia. Novo Nordisk. For the Spanish translation of the abstract see Supplementary Materials section.

Behavioral Sleep Interventions and Cardiovascular Risk Factors: Systematic Review and Meta-analysis of Randomized Controlled Trials.

Chronic sleep disturbance has been consistently associated with cardiovascular disease. We sought to determine whether behavioral interventions to improve sleep have been associated with improvements in 4 common cardiovascular disease risk factors: hypertension, diabetes mellitus (DM), obesity, and smoking. Randomized controlled trials evaluating the prospective effect of behavioral sleep interventions on ( a ) blood pressure in participants with hypertension/prehypertension, ( b ) glycemic control in participants with DM/pre-DM, ( c ) anthropometrics in participants who were overweight/obese, and ( d ) smoking status in smokers were eligible. Where feasible, we undertook random-effects meta-analyses of standardized mean differences in cardiovascular disease risk factor change. Overall, 3 trials met the inclusion criteria for blood pressure, 4 for glycemic control, 9 for overweight/obesity, and 2 for smoking. On meta-analysis, interventions with sleep as the sole behavioral target were associated with a significant reduction in hemoglobin A 1c % (-0.84; 95% confidence interval [CI], -1.34 to -0.34), but not a significant reduction in systolic blood pressure (-0.18; 95% CI, -0.55 to 0.20) versus controls. In addition, any interventions with sleep as a behavioral target were associated with significant reductions in hemoglobin A 1c % (-0.71; 95% CI, -1.01 to -0.42) and weight (-0.78; 95% CI, -1.11 to -0.45), but not systolic blood pressure (-0.72; 95% CI, -1.82 to 0.37). Trials evaluating smoking status were not amenable to meta-analysis. Behavioral interventions to improve sleep were associated with improved glycemic control in patients with DM. It is also possible that these interventions improve weight in individuals who were overweight/obese. A low number of trials and small sample sizes indicate that further large, well-designed randomized controlled trials of interventions are warranted.

167-LB: Knowledge Retention and Glycemic Control in Participants of Kids in Control of Food (KICk OFF) Program—Virtual vs. On-Site

Introduction: Kids In Control Of Food (KICk OFF) is a structured educational program for children with T1D from ages 11 to 16 years old. Due to the COVID-19 pandemic, the program was adapted and delivered virtually to accommodate regulations. It is unclear whether the virtual adaptation provides the same learning experience and effect on glycemic control as the original on-site version. Objectives: To compare both HbA1c and knowledge retention between participants who completed the program virtually versus on-site. Methods: A knowledge retention test of 15 questions was developed addressing the main diabetes concepts explained during KICk OFF: diabetes, insulin, carbohydrate counting, etc. This test was distributed to all the participants (virtual/on-site) 6 months after the completion of the course. Their knowledge retention tests were scored as a percentage of correct answers to total questions. HbA1c was recorded at baseline and 6 months. A t-test was used for statistical analysis. Results: A total of 43 participants attended KICk OFF (23 on-site, 20 virtual). A significantly higher knowledge retention test score was achieved in the on-site group (p-value=0.015) (Table 1). An insignificant reduction of HbA1c of 0.3% was observed in the on-site group after 6 months, and no reduction in the virtual group (Table 2). Table 1: Mean retention test scores for the on-site and virtual participants. Table 2: Mean HbA1c for the on-site and virtual participants. Discussion: Although virtual KICk OFF was necessary during COVID-19, the results indicated a superiority in the on-site KICk OFF course in terms of knowledge retention, as well as HbA1c reduction. Further research is recommended. Disclosure R. Almatrook: None. N. Taha: None. Z. Rahme: None. A. Alqabandi: None.

Is self-reported adherence a valid measure of glycaemic control among people living with diabetes in rural India? A cross-sectional analysis

BackgroundVisual analogue scale (VAS) is one of the simplest to measure medication adherence. It has neither been widely used for Non communicable diseases (NCD) nor validated for in the Indian setting. We examined the validity of self-reported medication adherence measures in relation to HbA1C in a rural population with diabetes mellitus (DM). MethodsParticipants with DM was administered VAS, Diabetes Self-Management Questionnaire (DMSQ) and assessed for missed pills. Descriptive statistics and logistic regression analysis were done. ResultsWe recruited 1347 participants and 84% of them reported being 100% adherent as per VAS and 83.8% stated that they did not miss any pills. However, 58.2% of participants who reported having 100% adherence had poor glycaemic control, as did 58.1% of those who did not miss any pills. None of the diabetic self-care measures was significantly associated with glycaemic control. ConclusionWe found a lack of association between self-reported adherence measures and glycaemic control in participants with DM suggesting that self-reported adherence scales may not be valid in this population.

Socioeconomic deprivation is associated with reduced efficacy of an insulin adjustment education program for people with type 1 diabetes.

The Dose Adjustment for Normal Eating (DAFNE) course teaches insulin dose adjustment to match dietary carbohydrates and improve glycaemic control in participants with type 1 diabetes mellitus (T1DM). We investigated the association between socioeconomic deprivation and reduction in HbA1c as a marker of sustained glycaemic control, after attending DAFNE education. This retrospective observational study identified adults with T1DM who attended DAFNE training in NHS Lothian, South East Scotland. We extracted age, sex, postcode-based Scottish Index of Multiple Deprivation (SIMD) quintiles and annual HbA1c measurements available four years before and after course attendance. We calculated mean HbA1c before (baseline) and after attendance at DAFNE, across four annual measurements. Change in mean HbA1c (mmol/mol) was categorised into three groups: decrease (≥ - 2.5), no change (<±2.5), increase (≥ + 2.5). We used multivariable ordinal logistic regression, with baseline mean HbA1c as a covariate, to investigate the association of SIMD quintile with reduction in mean HbA1c. 335 participants were included. Age and sex distribution were similar across SIMD quintiles (Mean age=45, range 21-91, 59% women). Lower SIMD quintiles (greater deprivation) had higher baseline mean HbA1c (SIMD 1: 76.0, SIMD 5: 69.0). Higher SIMD quintiles (lower deprivation) were associated with lower odds of no change/increase in mean HbA1c (SIMD 5, odds ratio=0.25, 95% confidence interval 0.10, 0.58, p=0.001, multivariable analysis). Socioeconomic deprivation was associated with higher baseline mean HbA1c and lower reduction in HbA1c following DAFNE education. Future research could explore causes and how best to support participants from deprived areas. This work has not been previously submitted to a journal. This work was presented as a poster at The ABCD Conference 2021 and the abstract (of no more than 300 words) from the meeting has been published: Innes CWD, Henshall DE, Wilson B, Poon M, Morley SD, Ritchie SA. Socioeconomic deprivation is associated with reduced efficacy of an insulin adjustment education programme for people with type 1 diabetes. Br J Diabetes. 2021; 21: 293-296.

Glycaemic control and its associated factors in patients with type 2 diabetes in the Middle East and North Africa: Anupdated systematic review and meta-analysis.

AimsTo examine the patient‐related factors that have been linked to glycaemic control in people living with type 2 diabetes mellitus in Middle Eastern countries.DesignA systematic review and meta‐analysis.Data SourcesA computerized search was conducted using the databases MEDLINE (via PubMed and Ovid), EMBASE, Scopus and CINAHL to identify peer‐reviewed articles published in English between 1 January 2010 and 21 May 2020. On 28 June 2021, the search was updated with the same keywords and databases; however, no further relevant studies were identified.Review MethodsExtracted data were analysed using Review Manager 5.4.ResultsThe final sample consisted of 54 articles with a total of 41,079 participants. Pooled data showed an increased risk of inadequate glycaemic control in smokers [OR = 1.26, 95% confidence interval (CI): 1.05, 1.52; p = .010], obese patients (OR = 1.30, 95% CI: 1.10, 1.54; p = .002), patients with elevated waist to hip ratio (OR = 1.62, 95% CI: 1.16, 2.26; p = .004) and longer disease duration (OR = 2.01, 95% CI: 1.64, 2.48; p < .001). A lower risk of inadequate control was associated with physical activity (OR = 0.40, 95% CI: 0.24, 0.67; p < .001) and self‐management (OR = 0.49, 95% CI: 0.29, 0.82; p = .006).ConclusionThese findings highlight the opportunity to address factors to improve glycaemic control. Further longitudinal studies are required to better understand these variations, to assess all predictors of glycaemic control in participants with type 2 diabetes, and to provide a strong basis for future measures to optimize glycaemic control.

Trends in Glycemic Control Among Youth and Young Adults With Diabetes: The SEARCH for Diabetes in Youth Study.

To describe temporal trends and correlates of glycemic control in youth and young adults (YYA) with youth-onset diabetes. The study included 6,369 participants with type 1 or type 2 diabetes from the SEARCH for Diabetes in Youth study. Participant visit data were categorized into time periods of 2002-2007, 2008-2013, and 2014-2019, diabetes durations of 1-4, 5-9, and ≥10 years, and age groups of 1-9, 10-14, 15-19, 20-24, and ≥25 years. Participants contributed one randomly selected data point to each duration and age group per time period. Multivariable regression models were used to test differences in hemoglobin A1c (HbA1c) over time by diabetes type. Models were adjusted for site, age, sex, race/ethnicity, household income, health insurance status, insulin regimen, and diabetes duration, overall and stratified for each diabetes duration and age group. Adjusted mean HbA1c for the 2014-2019 cohort of YYA with type 1 diabetes was 8.8 ± 0.04%. YYA with type 1 diabetes in the 10-14-, 15-19-, and 20-24-year-old age groups from the 2014-2019 cohort had worse glycemic control than the 2002-2007 cohort. Race/ethnicity, household income, and treatment regimen predicted differences in glycemic control in participants with type 1 diabetes from the 2014-2019 cohort. Adjusted mean HbA1c was 8.6 ± 0.12% for 2014-2019 YYA with type 2 diabetes. Participants aged ≥25 years with type 2 diabetes had worse glycemic control relative to the 2008-2013 cohort. Only treatment regimen was associated with differences in glycemic control in participants with type 2 diabetes. Despite advances in diabetes technologies, medications, and dissemination of more aggressive glycemic targets, many current YYA are less likely to achieve desired glycemic control relative to earlier cohorts.

Long-Term Complications in Youth-Onset Type 2 Diabetes

BackgroundThe prevalence of type 2 diabetes in youth is increasing, but little is known regarding the occurrence of related complications as these youths transition to adulthood.MethodsWe previously conducted a multicenter clinical trial (from 2004 to 2011) to evaluate the effects of one of three treatments (metformin, metformin plus rosiglitazone, or metformin plus an intensive lifestyle intervention) on the time to loss of glycemic control in participants who had onset of type 2 diabetes in youth. After completion of the trial, participants were transitioned to metformin with or without insulin and were enrolled in an observational follow-up study (performed from 2011 to 2020), which was conducted in two phases; the results of this follow-up study are reported here. Assessments for diabetic kidney disease, hypertension, dyslipidemia, and nerve disease were performed annually, and assessments for retinal disease were performed twice. Complications related to diabetes identified outside the study were confirmed and adjudicated.ResultsAt the end of the second phase of the follow-up study (January 2020), the mean (±SD) age of the 500 participants who were included in the analyses was 26.4±2.8 years, and the mean time since the diagnosis of diabetes was 13.3±1.8 years. The cumulative incidence of hypertension was 67.5%, the incidence of dyslipidemia was 51.6%, the incidence of diabetic kidney disease was 54.8%, and the incidence of nerve disease was 32.4%. The prevalence of retinal disease, including more advanced stages, was 13.7% in the period from 2010 to 2011 and 51.0% in the period from 2017 to 2018. At least one complication occurred in 60.1% of the participants, and at least two complications occurred in 28.4%. Risk factors for the development of complications included minority race or ethnic group, hyperglycemia, hypertension, and dyslipidemia. No adverse events were recorded during follow-up.ConclusionsAmong participants who had onset of type 2 diabetes in youth, the risk of complications, including microvascular complications, increased steadily over time and affected most participants by the time of young adulthood. Complications were more common among participants of minority race and ethnic group and among those with hyperglycemia, hypertension, and dyslipidemia. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov numbers, NCT01364350 and NCT02310724.)

26-LB: Glycemic Control in People with Type 1 Diabetes Mellitus after the First Portuguese COVID-19–Related State of Emergency

Introduction: The first Portuguese COVID-19-related state of emergency (SE) extended between March and May 2020. The relevance of achieving the glycemic target for the person with type 1 Diabetes Mellitus (T1DM) is deepened in these circumstances, given the forced changes in daily routine. Objective: To determine the influence of work activity (WA) on glycemic control (GC) of adults with T1DM after the first SE. Material and methods: A retrospective cohort study was designed to enroll adults with ≥2 years from T1DM diagnosis. Cases of pregnancy/hospitalizations in 2019/2020, factors that affect interpretation of glycated hemoglobin (HbA1c) and/or SARS-CoV-2 infections were excluded. The participants were stratified into groups of WA after the SE: g1 (telework/lay-off/students), g2 (retired/unemployed) and g3 (WA without lockdown). HbA1c were obtained from 4 periods: t3 (4/1-6/1/2020); t4 (7/1-9/1/2020); t1 and t2 (homologous periods of 2019). Differences in HbA1c were calculated in both years and compared to each other in the same group and between groups in the same year. Hypoglycemia and insulin regimens (insulin pump and multiple injections daily) were analyzed in intragroup (t3 vs. t4) and intergroup (t3 and t4) comparisons. Results: Two hundred and seven participants were included [106 (51.2%) men; median age of 35 (25;47) years]: 144 (69.6%) in g1, 44 (21.3%) in g2 and 19 (9.2%) in g3. HbA1c increased significantly between t4 and t3 (vs. t2 and t1) in g1 (p=0.001), but not in g2 (p=0.077) and g3 (p=0.744). In 2020, HbA1c raised significantly in the analysis "g1 vs. g3" (p=0.004), but not in "g1 vs. g2" (p=0.213) and "g2 vs. g3" (p=0.083). No differences were reported in 2019, along with all the comparisons involving hypoglycemia and insulin regimens. Conclusions: This study found an overall worsening of GC in participants who returned to higher levels of activity after a total lockdown. This is probably explained by the time spent on T1DM self-care during the lockdown. Disclosure D. Ramalho: None. S. Correia: None. L. Almeida: None. H. Alves: None. G. Rocha: None. M. Ferreira: None. M. J. Oliveira: None.

Factors Predicting Adequate Glycemic Control after Participation in Diabetes Self-Management Education and Support Program: The Role of Behavioral Change

Objective: To explore the predictors of achieving adequate glycemic control at a 6-months follow-up in patients with type 2 diabetes (T2D) who participated in the diabetes self-management education and support (DSMES) program. Materials and Methods: A retrospective cohort study of T2D patients who completed the DSMES program (an initial visit and a 3-month follow-up) at Ramathibodi Hospital between 2014 and 2017 was conducted. Behavioral goals were set at the initial visit and whether these were achieved by the patients was assessed at a 3-month follow-up. Diabetes history, baseline, and 6-month hemoglobin A1C (HbA1c) values were collected. Multiple logistic regression analyses were performed to determine independent predictors of adequate glycemic control at 6-month, defined as HbA1c of less than 7% or less than 7.5% in those younger than 65 years or those 65 years or older, respectively. Results: Ninety-two patients were included, with a mean (SD) age 60.7 (10.9) years, an average diabetes duration of 9.1 (9.5) years and 51.1% were using insulin. Seventy-six patients (82.6%) reported that they achieved behavioral goals as set at the initial visit, and 56.5% had adequate glycemic control at 6-month. Multiple regression analysis adjusting for age, baseline HbA1c, and insulin use revealed that behavioral goal achievement at three months was independently associated with HbA1c achievement at six months (OR 3.473, 95% CI 1.005 to 12.001), while higher baseline HbA1c was associated with a lower likelihood of achieving adequate glycemic control (OR 0.727, 95% CI 0.540 to 0.979). Conclusion: Behavioral goal achievement was an independent predictor of adequate glycemic control in participants of the DSMES programs, suggesting that adherence to behavioral changes can improve clinical outcomes. Goal setting skills should be adopted by diabetes educators and incorporated as a key part of DSMES process. Keywords: Factors predicting glycemic control, Diabetes self-management education, Behavioral goal achievement, Diabetic educators

Improving physical activity within diabetes care: Preliminary effects and feasibility of a national low‐intensity group‐based walking intervention among people with type 2 diabetes mellitus

AbstractIntroductionDespite the positive outcomes of physical activity (PA) interventions on health and PA behavior in people with type 2 diabetes mellitus (T2DM), it proves rather difficult to structurally implement such interventions in daily diabetes care. The National Diabetes Challenge (NDC) was designed as a low‐intensity and low‐cost annual walking intervention for people with T2DM, with the aim to overcome potential barriers in intervention delivery. The aim of the present study was to explore the feasibility and preliminary efficacy of this approach.MethodsThis feasibility study had a pre/posttest design. First, we assessed acceptability and feasibility by means of posttest process evaluations among participants and healthcare providers. Second, to examine preliminary efficacy we studied emotional well‐being and patient activation among 822 participants with T2DM, and number of daily steps and somatic health outcomes in a subgroup of 189 participants with T2DM. These data were analyzed using paired‐samples t‐tests.ResultsThe intervention was generally well‐received by both the participants and healthcare providers, people reporting satisfaction and perceived benefits. The results show improved glycemic control in participants with above target baseline HbA1c, improved patient activation in participants with lower activation at baseline, and decrease of body weight and improved emotional well‐being in all participants. Furthermore, the number of daily steps taken increased during the intervention.ConclusionsThis feasibility study did show acceptability and generally good feasibility with regard to implementation, and provides initial evidence for the effectiveness of a group‐based walking intervention with weekly group supervision, with improved behavioral, somatic and psychological outcomes in people with T2DM. Our findings highlight the potential of a low‐intensity group‐based walking intervention in increasing PA behavior in people with T2DM, while also taking into account common barriers regarding structural implementation in diabetes care. The study provides support for a more rigorous testing of the NDC program.

868-P: Live Coaching Improves Glycemic Control and DSMQ Scale in People with Type 2 Diabetes

People with diabetes face numerous challenges to effective self-management of blood glucose (BG) including access to diabetes education and support. This study explores how a coaching program structured around the AADE7 Self-Care Behaviors™ and evidence-based behavior change strategies optimized for remote interaction between the coach and participant can improve glycemic control. Certified Diabetes Educator coaches used a care management platform, Welkin Health, that displays BG test results from integration with the OneTouch Reveal diabetes mobile app. Welkin supports communication methods with patients including email, SMS and telephone communication. The software platform also uses logic to prioritize patients who need attention so the coach can better manage their relationship with the participant. Adult participants with type 2 diabetes and HbA1c ≥8.0% received an AccuBase A1c mail-in test kit at baseline and weeks 12 and 24 to measure their HbA1c levels. Each participant used a OneTouch Verio Flex glucose meter connected by Bluetooth to OneTouch Reveal app. After 12 weeks (n=67), mean HbA1c declined by 0.85% from 9.19% to 8.34% (p&amp;lt;0.05) and 65% of subjects had an HbA1c decrease of &amp;gt;0.5%. After 24 weeks, mean change in HbA1c was still 0.78% less than baseline (p&amp;lt;0.05) with 51% of participants experiencing a decline of &amp;gt;0.5%. The decline in HbA1c occurred without any increase in hypoglycemic events. There was a 14.1% increase in % of results in range (p&amp;lt;0.05). Improvement in HbA1c came without any substantial change in testing frequency. In addition, there were various positive changes in the Diabetes Self-Management Questionnaire (DSMQ) scale. In conclusion, live coaching using the Welkin Patient Relationship Management technology in conjunction with the OneTouch Reveal diabetes app resulted in significant improvement in glycemic control in participants with type 2 diabetes who were in relatively poor control. Disclosure L.B. Katz: Employee; Self; LifeScan, Inc. K.D. Neland: Research Support; Self; LifeScan, Inc. D.J. Rolando: None. D.M. Shearer: None.

Effects of Palmaria palmata on lipid metabolism and glycemic control in participants with hypercholesterolemia in a randomized double-blind placebo-controlled trial.

Red algae have been reported to improve lipid and glucose metabolism in rats. We investigated the effects of Palmaria palmata (P. palmata), a red alga from northern Japan, on lipid metabolism and glycemic control in participants with hypercholesterolemia. We conducted an 8-week, randomized, double-blind, placebo-controlled, and parallel-group comparison trial. The study enrolled Japanese participants with a serum low-density protein cholesterol (LDL-C) ≥120 mg/dL. The participants were randomly assigned to take either capsules containing P. palmata (2 g/day) or placebo capsules. The primary endpoint was the change in LDL-C from baseline to week 8 and the secondary endpoints were the changes in other lipid parameters and glycemic control. Of the 104 participants completed the study protocol. There were no significant differences in change in LDL-C, body mass index, waist circumference, or glycemic control between the two groups. However, serum triglyceride showed significantly greater improvement in women in the P. palmata group (-9.0 [-25.0, +5.0]) vs. those in the placebo group (-1.0 [-11.0, +19.0]; p = .03). The present study did not show that P. palmata had significant effect on serum LDL-C nor glycemic control, but hypertriglyceridemia could be ameliorated by administration of P. palmata in women.

Participation in a Virtual Diabetes Clinic Improves Glycemic Control in Adults with Type 2 Diabetes

Background Telemedicine for people with type 2 diabetes (T2D) has the potential to positively impact self-management behaviors and improve health outcomes. The Onduo Virtual Diabetes Clinic (VDC) is a comprehensive telehealth program for people with T2D that combines mobile app technology, remote personalized lifestyle coaching from certified diabetes educators and health coaches, connected devices including blood glucose meters and continuous glucose monitoring systems, and clinical support from board certified endocrinologists. Objective To describe the VDC care delivery model and present preliminary data on change in glycemic control in program participants with up to 6 months of follow-up. Methods Adults ≥18 years of age with T2D and who were members of sponsoring health plans and employers throughout the US were eligible to participate. Those who elected to enroll downloaded the VDC app to their smartphone, provided demographic and clinical information, completed an onboarding survey, and were mailed a self-management kit that included a connected blood glucose meter, test strips and a home glycosylated hemoglobin (HbA1c) testing kit. Participants interacted with their care team primarily through the VDC app, with occasional phone calls, and by synchronous video consultations with endocrinologists, as clinically appropriate. Change in glycemic control in participants who completed a baseline survey from February 2018 through December 31, 2018, with an initial HbA1c measurement within 30 days of enrollment and a follow-up measurement between 90 and 180 days after baseline was analyzed. Results Participants (n=740) were (mean ± SD): 53.8 ± 8.8 years of age, 62% female, BMI 35.6 ± 8.5, initial HbA1c 7.7% ± 1.8, 31.0% were on insulin and 25.9% were on sulfonylureas at baseline, and 30.0% lived in a rural area. HbA1c decreased significantly by 2.3% ± 1.9, 0.7% ± 1.0 and 0.2% ± 0.8 across the baseline categories of &gt;9.0%, 8.0% to 9.0% and 7.0% to &lt;8.0%, respectively (all P&lt;.001). Within these categories, HbA1c improved in 91.9%, 77.3% and 63.5% of participants. For the group with an initial HbA1c &gt;9.0%, HbA1c decreased from 10.7% ± 1.4 to 8.3% ± 1.5, and when stratified by HbA1c ≥8.0% the mean decrease in HbA1c was 1.5%, from 9.5% ± 1.5 to 8.0% ± 1.3, with 84.5% of participants demonstrating improvement. Participants with an initial HbA1c &lt;7.0% who were meeting treatment targets at baseline, HbA1c 6.3% ± 0.4, continued to maintain this level of glycemic control at follow-up, HbA1c 6.4% ± 0.6 (ns). Conclusions Participation in the VDC was associated with a significant improvement in HbA1c in adults with T2D who were not meeting treatment targets, with the greatest improvement observed in those with an initial HbA1c &gt;9.0%. Importantly, the majority of program participants experienced an improvement in glycemic control. Our findings suggest that the VDC program is an effective approach to support individuals with T2D and their clinicians in diabetes management between office visits.

Highlights from the Diabetes UK Professional Conference 2018

Highlights from the Diabetes UK Professional Conference 2018

Hypoglycemic Event Frequency and the Effect of Continuous Glucose Monitoring in Adults with Type 1 Diabetes Using Multiple Daily Insulin Injections.

IntroductionThe benefits of continuous glucose monitoring (CGM) in type 1 diabetes have been established among adults using insulin pumps. The DIAMOND randomized clinical trial examined the effectiveness of using CGM in improving glycemic control in participants using insulin injections. The frequency of hypoglycemic events in this trial has not been previously examined.MethodsAdults with type 1 diabetes using multiple daily insulin injections (MDI) with A1C values of 7.5% to 9.9% and not using CGM were randomized to adopt CGM (CGM group, n = 105) or continue with usual care (control group, n = 53). CGM data were collected from both groups at the beginning of the study and after 3 and 6 months. A hypoglycemic event was defined as a series of at least CGM values less than 3.0 mmol/L, separated by 20 min or more, with no intervening values of 3.0 mmol/L or more. Hypoglycemic event rates per 24 h were compared using a linear model adjusted for the baseline event rate per 24 h, baseline A1C, and site as a random effect.ResultsIn the CGM group, the median hypoglycemic event rate fell by 30% (0.23 per 24 h at baseline and 0.16 per 24 h at follow-up) while in the control group the rate was nearly unchanged (0.31 per 24 h at baseline and 0.30 per 24 h at follow-up; p value = 0.03).ConclusionIn the DIAMOND randomized controlled trial, participants in the CGM group experienced a greater reduction in hypoglycemic event rate than participants receiving usual care in the control group.Trial RegistrationClinicaltrials.gov Identifier: NCT02282397.

Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial

Aims/hypothesisSemaglutide is a glucagon-like peptide-1 analogue in development for the treatment of type 2 diabetes. Its effects on first- and second-phase insulin secretion and other measures of beta cell function and glycaemic control were assessed.MethodsIn this single-centre, double-blind, placebo-controlled, parallel-group trial, conducted at the Profil Institut für Stoffwechselforschung, Germany, 75 adult (aged 18–64 years) participants with type 2 diabetes (eligibility: HbA1c of 6.5–9.0% (47.5–74.9 mmol/mol); BMI 20.0–35.0 kg/m2; and treatment with diet and exercise and/or metformin monotherapy with a dose unchanged in the 30 days prior to screening) were randomised (1:1) to once-weekly s.c. semaglutide 1.0 mg (0.25, 0.5, 1.0 mg escalated) or placebo for 12 weeks. Co-primary endpoints were changes from baseline to end of treatment in the first (AUC0–10 min) and second (AUC10–120 min) insulin secretion phases, as measured by the IVGTT. An arginine stimulation test (AST) and a 24 h meal stimulation test were also conducted. A graded glucose infusion test (GGIT) assessed insulin secretion rate (ISR) in treated participants and a group of untreated healthy participants. Safety endpoints were also assessed.ResultsIn total, 37 participants received semaglutide and 38 received placebo. Following IVGTT, for insulin, both AUC0−10min and AUC10−120min were significantly increased with semaglutide (estimated treatment ratio [95% CI] 3.02 [2.53, 3.60] and 2.10 [1.86, 2.37], respectively; p < 0.0001). The 24 h meal test showed reduced fasting, postprandial and overall (AUC0–24h) glucose and glucagon responses with semaglutide (p < 0.0001). The AST showed that maximal insulin capacity increased following semaglutide treatment. During GGIT, semaglutide significantly increased ISR to levels similar to those in healthy participants. Semaglutide was well tolerated.Conclusions/interpretationTwelve weeks of once-weekly treatment with semaglutide significantly improved beta cell function and glycaemic control in participants with type 2 diabetes.Trial registration:ClinicalTrials.gov NCT02212067Funding:The study was funded by Novo Nordisk A/S.

The Effect of OSA Therapy on Glucose Metabolism: It's All about CPAP Adherence!

The Effect of OSA Therapy on Glucose Metabolism: It's All about CPAP Adherence!

A Large Difference in Dose Timing of Basal Insulin Introduces Risk of Hypoglycemia and Overweight: A Cross-Sectional Study.

IntroductionBasal insulin should be injected at the same time each day, but people with diabetes sometimes mistime their injections. It is not known whether irregular daily dose timing affects diabetes-related factors. We report here our evaluation of the effects of deviations from a regular dosing schedule on glycemic control and hypoglycemia on patients treated with long-acting insulin (insulin glargine U100). We also consider the effects of ultra-long-acting insulin (insulin degludec) in this context.MethodsNineteen individuals with type 1 diabetes and 58 with type 2 diabetes were enrolled. Demographic data on all participants were retrieved from their medical records. Variation in dose timing was determined as the difference between the time of the earliest mistimed dose and the time of the latest mistimed dose, for each participant, over a 2-week period. All participants completed the Summary of Diabetes Self-Care Activities questionnaire, Problem Areas in Diabetes scale and 5-Item World Health Organization Well-being Index. Glargine U100 was switched to degludec in those individuals with type 2 diabetes who achieved inadequate glycemic control or suffered from frequent hypoglycemic episodes or who required two injections per day, and changes in hemoglobin A1c level and frequency of hypoglycemic episodes during the 12-week period were compared.ResultsA greater difference in dose timing was related to a higher frequency of hypoglycemic episodes and overweight in persons with type 2 diabetes. Smoking, drinking and living alone were independently associated with a greater difference in dose timing. Insulin degludec decreased the frequency of hypoglycemia and improved glycemic control in participants whose dose mistiming was >120 min.ConclusionFixed dose timing should be employed for basal insulin, as a larger difference in dose timing worsens diabetes-related factors. Insulin degludec improved glycemic control and lowered the hypoglycemia rate in persons with more irregular dose timing.

Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial.

IntroductionGlycemic control in participants with insulin-treated diabetes remains challenging. We assessed safety and efficacy of new flash glucose-sensing technology to replace self-monitoring of blood glucose (SMBG).MethodsThis open-label randomized controlled study (ClinicalTrials.gov, NCT02082184) enrolled adults with type 2 diabetes on intensive insulin therapy from 26 European diabetes centers. Following 2 weeks of blinded sensor wear, 2:1 (intervention/control) randomization (centrally, using biased-coin minimization dependant on study center and insulin administration) was to control (SMBG) or intervention (glucose-sensing technology). Participants and investigators were not masked to group allocation. Primary outcome was difference in HbA1c at 6 months in the full analysis set. Prespecified secondary outcomes included time in hypoglycemia, effect of age, and patient satisfaction.ResultsParticipants (n = 224) were randomized (149 intervention, 75 controls). At 6 months, there was no difference in the change in HbA1c between intervention and controls: −3.1 ± 0.75 mmol/mol, [−0.29 ± 0.07% (mean ± SE)] and −3.4 ± 1.04 mmol/mol (−0.31 ± 0.09%) respectively; p = 0.8222. A difference was detected in participants aged <65 years [−5.7 ± 0.96 mmol/mol (−0.53 ± 0.09%) and −2.2 ± 1.31 mmol/mol (−0.20 ± 0.12%), respectively; p = 0.0301]. Time in hypoglycemia <3.9 mmol/L (70 mg/dL) reduced by 0.47 ± 0.13 h/day [mean ± SE (p = 0.0006)], and <3.1 mmol/L (55 mg/dL) reduced by 0.22 ± 0.07 h/day (p = 0.0014) for intervention participants compared with controls; reductions of 43% and 53%, respectively. SMBG frequency, similar at baseline, decreased in intervention participants from 3.8 ± 1.4 tests/day (mean ± SD) to 0.3 ± 0.7, remaining unchanged in controls. Treatment satisfaction was higher in intervention compared with controls (DTSQ 13.1 ± 0.50 (mean ± SE) and 9.0 ± 0.72, respectively; p < 0.0001). No serious adverse events or severe hypoglycemic events were reported related to sensor data use. Forty-two serious events [16 (10.7%) intervention participants, 12 (16.0%) controls] were not device-related. Six intervention participants reported nine adverse events for sensor-wear reactions (two severe, six moderate, one mild).ConclusionFlash glucose-sensing technology use in type 2 diabetes with intensive insulin therapy results in no difference in HbA1c change and reduced hypoglycemia, thus offering a safe, effective replacement for SMBG.Trial registrationClinicalTrials.gov identifier: NCT02082184.FundingAbbott Diabetes Care.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-016-0223-6) contains supplementary material, which is available to authorized users.