Mean Difference In HbA1c Research Articles

The effectiveness of telemonitoring and integrated personalized diabetes management in people with insulin-treated type 2 diabetes mellitus.

To evaluate the effectiveness of integrated personalized diabetes management (iPDM) through telemedicine (tele-iPDM) with regard to glycaemic control. A 6-month single-centre, open-label, prospective randomized controlled trial enrolled insulin-treated patients with type 2 diabetes, aged 18-65 years with glycated haemoglobin (HbA1c) levels of 7.5%-10.5%. The tele-iPDM group received insulin adjustment by investigators through a cloud-based telemonitoring platform for 6 months (blood glucose monitoring reviewed weekly from Weeks 0 to 12 and then monthly from Weeks 13 to 24). The control group performed self-monitoring and insulin adjustment. The primary outcome was the difference in HbA1c change from baseline between the two groups at 24 weeks. Secondary outcomes included changes in HbA1c at 12 weeks, fasting plasma glucose, body weight, body mass index (BMI), the percentage of individuals achieving HbA1c <7% at 24 weeks, the percentage of individuals with an HbA1c reduction of >0.5% at 24 weeks, and incidences of hypoglycaemic events. A total of 151 participants were enrolled, with a mean age of 53.36 ± 8.08 years and a mean diabetes duration of 12.38 ± 8.47 years. The baseline HbA1c was 8.47 ± 0.76%. The mean HbA1c decreased from baseline to 12 and 24 weeks in both groups. At 12 weeks, HbA1c reduction from baseline was -1.2% (95%CI -1.42 to -0.98) in the tele-iPDM group and -0.57% (95%CI -0.79 to -0.36) in the control group. The mean difference in HbA1c between the tele-iPDM and usual care groups at 12 weeks was -0.63% (95%CI -0.94 to -0.32; p < 0.001). At 24 weeks, HbA1c reduction from baseline was -1.14% (95%CI -1.38 to -0.89) in the tele-iPDM group and - 0.49% (95%CI -0.73 to -0.25) in the control group. The mean difference in HbA1c between the tele-iPDM and usual care groups was -0.65% (95%CI -0.99 to -0.30; p < 0.001). There were no significant differences in body weight, BMI, or hypoglycaemic events between the two groups. Telemonitoring can support the iPDM care model in individuals with insulin-treated type 2 diabetes. It improves the efficiency of diabetes care, enhances glycaemic control at 12 weeks, and sustains glycaemic control at 24 weeks.

Comparison of Glycated Hemoglobin (Hba1c%) between High Performance Liquid Chromatography (HPLC) and Non-HPLC Methodology

Background: Glycated hemoglobin (HbA1c) serves as a pivotal marker for the long-term management of glucose levels in patients with diabetes. Accurate measurement of HbA1c is crucial for effective diabetes management and prevention of associated complications. While High-Performance Liquid Chromatography (HPLC) is widely used, non-HPLC methods have also gained popularity due to their simplicity and cost-effectiveness. Discrepancies in measurement between these methods have been a concern, impacting clinical decisions. Objective: The objective of this study was to compare the measurement of HbA1c% using HPLC and non-HPLC methods in a cohort of diabetic patients, evaluating the consistency and reliability of these methodologies. Methods: A cross-sectional study was conducted at Hayatabad Medical Complex, MTI, Peshawar from November 2023 to March 2024. A total of 65 diabetic patients aged between 18 and 70 years were enrolled. Participants were excluded if they had conditions known to affect HbA1c measurement. HbA1c levels were measured using both HPLC and non-HPLC methods. Statistical analysis was performed using SPSS version 25, employing t-tests to compare the mean HbA1c levels and Bland-Altman analysis to assess agreement between the two methods. Results: The HPLC method showed a mean HbA1c% of 8.2 (SD = 1.4) while the non-HPLC method showed a mean HbA1c% of 7.6 (SD = 1.3). The Bland-Altman analysis indicated that 91.5% of the values fell within the limits of agreement, suggesting substantial agreement between the methods. The mean difference in HbA1c% between methods was 0.6%, with limits of agreement from -0.3 to 1.5. Conclusion: Both HPLC and non-HPLC methods provided reliable HbA1c measurements, with a high degree of agreement. Despite minor discrepancies in mean values, both methodologies are suitable for the clinical monitoring of glycemic control in diabetic patients. Further studies with larger sample sizes and multiple centers are recommended to validate these findings.

Evaluation of Glycosylated Hemoglobin Levels and Effect of Tobacco Smoking in Periodontally Diseased Non-Diabetic Patients

Background and Objective Chronic diseases have progressively increased worldwide, impacting all areas and socioeconomic groups. Periodontal disease is an increasing global concern and contains risk factors similar to other chronic illnesses. The main risk factor for periodontitis is smoking. Smoking not only hastens periodontal disease but also complicates periodontal therapy. Serum glycosylated hemoglobin levels, which are derived from the average life span of an erythrocyte, are a good indicator of glycemic management during the preceding one to three months. This study was undertaken to assess the association between tobacco smoking and periodontal disease by evaluating plaque score, gingival score, extent and severity index (ESI), and glycemic status by estimating serum HbA1c in cigarette smoker patients compared to non-smokers. Methods The study was conducted with 40 patients in the age range of 20–40 years. Patients were divided into two groups: non-smokers (Group I) and cigarette smokers (Group II). Periodontal clinical parameters such as the plaque index (PI), gingival index (GI), and ESI were recorded during the oral cavity examination. The biochemical marker, serum glycosylated hemoglobin, was measured in both groups. All parameters were measured at baseline and three months after periodontal therapy. The statistical tests used were the paired t-test, and Chi-square test for comparison between both groups. Results The mean difference of PI of non-smokers was 0.33 ± 0.30, and smokers were 0.52 ± 0.32, which was statistically significant. The mean difference of GI of non-smokers was 0.34 ± 0.19 and smokers 0.36 ± 0.303, which was statistically significant. The mean difference of extent in non-smokers was 5.33 ± 1.59, 5.52 ± 2.43, and smokers were 0.18 ± 0.17. The mean difference in severity in non-smokers was 0.18 ± 0.17, and smokers were 0.31 ± 0.25, which was statistically significant. The mean difference of HbA1c in non-smokers and smokers was 0.43 ± 0.277 and 0.415 ± 0.230, which shows a higher mean difference in non-smokers, which was statistically non-significant. Conclusion and Global Health Implications This study concluded that each of Group I and Group II showed substantial improvements in all clinical periodontal variables, which include plaque index (PI), gingival index (GI), extent and severity index (ESI), and biochemical marker serum glycosylated hemoglobin. Controlling inflammation with SRP can improve insulin resistance, lower glucose levels, and prevent non-enzymatic glycation of hemoglobin.

Evaluation of Glycosylated Hemoglobin Levels and Effect of Tobacco Smoking in Periodontally Diseased Non-Diabetic Patients.

Chronic diseases have progressively increased worldwide, impacting all areas and socioeconomic groups. Periodontal disease is an increasing global concern and contains risk factors similar to other chronic illnesses. The main risk factor for periodontitis is smoking. Smoking not only hastens periodontal disease but also complicates periodontal therapy. Serum glycosylated hemoglobin levels, which are derived from the average life span of an erythrocyte, are a good indicator of glycemic management during the preceding one to three months. This study was undertaken to assess the association between tobacco smoking and periodontal disease by evaluating plaque score, gingival score, extent and severity index (ESI), and glycemic status by estimating serum HbA1c in cigarette smoker patients compared to non-smokers. The study was conducted with 40 patients in the age range of 20-40 years. Patients were divided into two groups: non-smokers (Group I) and cigarette smokers (Group II). Periodontal clinical parameters such as the plaque index (PI), gingival index (GI), and ESI were recorded during the oral cavity examination. The biochemical marker, serum glycosylated hemoglobin, was measured in both groups. All parameters were measured at baseline and three months after periodontal therapy. The statistical tests used were the paired t-test, and Chi-square test for comparison between both groups. The mean difference of PI of non-smokers was 0.33 ± 0.30, and smokers were 0.52 ± 0.32, which was statistically significant. The mean difference of GI of non-smokers was 0.34 ± 0.19 and smokers 0.36 ± 0.303, which was statistically significant. The mean difference of extent in non-smokers was 5.33 ± 1.59, 5.52 ± 2.43, and smokers were 0.18 ± 0.17. The mean difference in severity in non-smokers was 0.18 ± 0.17, and smokers were 0.31 ± 0.25, which was statistically significant. The mean difference of HbA1c in non-smokers and smokers was 0.43 ± 0.277 and 0.415 ± 0.230, which shows a higher mean difference in non-smokers, which was statistically non-significant. This study concluded that each of Group I and Group II showed substantial improvements in all clinical periodontal variables, which include plaque index (PI), gingival index (GI), extent and severity index (ESI), and biochemical marker serum glycosylated hemoglobin. Controlling inflammation with SRP can improve insulin resistance, lower glucose levels, and prevent non-enzymatic glycation of hemoglobin.

Effectiveness of a group-based Diabetes Prevention Education Program (DiPEP) in a population with pre-diabetes: a cluster randomised controlled trial in Nepal

BackgroundAlthough several lifestyle intervention studies have been conducted in low/middle-income countries, there were no such studies in Nepal. Therefore, a group-based culturally tailored Diabetes Prevention Education Program (DiPEP) was conducted...

Effects of COVID-19 on diabetes care among dutch diabetes outpatients

AimsThe COVID-19 pandemic impacted diabetes care by reducing diabetes outpatient visits and diabetes-related screening due to allocation of healthcare resources. Yet the impact of COVID-19 on diabetes outpatients has not been extensively evaluated. This study aimed to assess the effect of the COVID-19 pandemic on diagnostics and intermediate outcomes of outpatient diabetes care pre- and during COVID.MethodsThis observational cohort study included 8,442 diabetes patients in the Dutch Pediatric and Adult Registry of Diabetes (DPARD) visiting diabetes outpatient clinics in 2019 and 2021. A mixed-effects regression analysis was used to examine differences in target achievement of HbA1c, BMI, blood pressure, LDL-cholesterol, eGFR, and the difference in mean HbA1c between 2019 and 2020 among n = 1,426 outpatients who visited in both years. Analyses were adjusted for age, sex, and BMI.ResultsA 22.7% (21.6–23.8%, p < 0.001) decline in outpatient volume was observed during the pandemic (2020). BMI, lipid spectrum, kidney function, and HbA1c were assessed less frequently in 2020 than in 2019. In 2020, compared to 2019, the median HbA1c level increased by 2.2% (1.0 mmol/mol, p = 0.035) and the percentages of patients with known HbA1C meeting targets below 10, 8, 7% (86, 64, and 53 mmol/mol) decreased by 0.5%, 1.7% and 1.4%, respectively. Target blood pressure ≤ 130/80 mmHg was achieved more often in 2020 (15.0% versus 18.3%, p = 0.018), while HbA1c ≤ 86 mmol/mol was achieved less (89.3% versus 87.1%, p = 0.001), among diabetes outpatients seen in both 2019 and 2020. In patients visiting both years, HbA1c was 2.3% (1.9 mmol/l, 95% CI 1.2–2.5, p < 0.001) lower during the pandemic than in the prepandemic (2019).ConclusionsThe COVID pandemic was associated with a marked reduction in patient volume in diabetes outpatient care among five hospitals. Among patients who received outpatient care both before and during the pandemic period, HbA1c control and blood pressure control enhanced during the pandemic. Re-evaluation of current diabetes outpatient care organization is warranted to ensure optimal diabetes care in future times.

SAT093 Closed-Loop Insulin Delivery Versus Standard Care In Type 1 Diabetic Pediatric Patients: A Meta-analysis Of Randomized Controlled Trials

Abstract Disclosure: L.C. Hespanhol: None. V.C. Moreira: None. A.C. Silva: None. I.R. Marques: None. A. Godoi: None. A. Mahesh: None. C. Oommen: None. C.H. Silva: None. C. Gomes: None. I.A. Souza: None. I.A. Miyawaki: None. J.E. Loyola Júnior: None. J. De Sa: None. E.M. Padrao: None. Background: Treatment of Type I Diabetes Mellitus (T1DM) in the pediatric population is a clinical challenge. The first closed-loop system (CL) was approved for pediatric use in 2020 with the aim of improving therapeutic and safety outcomes for patients. Since then, many randomized clinical trials have been performed, yet, to our knowledge no meta-analysis evaluating the effect of long-term CL on glycemia in children and adolescents with T1DM was performed. Purpose: To compare the therapeutic efficacy and safety of long-term use of CL insulin delivery systems to standard care (SC) in pediatric patients with T1DM. Methods: PubMed, Cochrane and EMBASE were systematically searched in October 2022 to include randomized controlled studies (RCTs) comparing CL systems (automated pancreas, hybrid CL and advanced hybrid CL) versus SC (daily insulin injections, sensor augmented pump and continuous glucose monitoring) with at least 12 weeks of duration. Outcomes assessed were percentage time in range (% TIR) 70-180mg/dL, change in HbA1c and percentage time with hypoglycemia (glucose &amp;lt; 70mg/dL). Statistical analysis were performed with RevMan 5.4.1 and R software. Heterogeneity was assessed with I² statistics and random-risk effect was used if I2 &amp;gt; 50%. The protocol was registered in PROSPERO (ID: CRD42022366710). Results: A total of 7 randomized studies with 827 patients with T1DM were included, of whom 471 (56.7%) used automated devices and 356 (43.3%) continued their usual care. The %TIR was significantly higher in the CL systems when compared to SC (MD 8.70%; 95% CI 7.08 to 10.31; p &amp;lt; 0.001; I² = 0%). Similarly, CL systems showed a significantly higher HbA1c mean difference when compared to SC (MD -0.38; 95% CI -0.59 to -0.16; p &amp;lt; 0.001; I² = 0%). When evaluating percentage time with hypoglycemia, the time was non-significantly lower in the CL system group when compared to SC (MD -0.47%; 95% CI -1.06 to 0.13; p = 0.12; I² = 55%). Conclusion: In this meta-analysis of randomized trials in pediatric population with T1DM, the use of CL insulin devices was associated with a higher proportion of time in the optimal glucose range and greater decrease of HbA1c relative to standard care, regardless of CL system type. However, the use of CL insulin delivery was not associated with less time in hypoglycemia range. Therefore, CL systems seem to be safe and superior to standard care regarding glycemic control. Presentation: Saturday, June 17, 2023

Physical activity and glycemic control among adults living with coronary heart disease

Abstract Funding Acknowledgements Type of funding sources: Public Institution(s). Main funding source(s): University of Akureyri Research Fund Landspitali University Hospital Science Fund Background The most common comorbidity in coronary heart disease (CHD) is diabetes mellitus (DM). The presence of DM or pre-diabetes mellitus in addition to CHD further increases health risks. Engagement in regular physical activity (PA) has been shown to improve health and well-being and increase life expectancy. For that reason, it is important to explore the role of PA when the diseases coexist and how PA can be used effectively as part of treatment to improve coronary patients’ health. Purpose The aim of the study was to explore the relationship between the level of PA and glycemic control in adults with CHD. Methods This study had a cross-sectional design. The participants were adults who had been admitted to one of two main hospitals in Iceland between October 2017 and November 2018 following a CHD incident. Data was collected six months after hospital discharge with questionnaires, physical measurements, blood samples, and from medical files. The Leisure-Time Physical Activity Questionnaire was used to measure PA. The participants were categorized into four groups according to their PA level (mostly sedentary; light; moderate; or high PA) and the relationship between PA levels and long-term glycemic control (glycated hemoglobin percentage (HbA1c%)) was explored using one-way ANOVA with Tukey post-hoc test. Results The sample consisted of 346 individuals. Their mean age was 64.6 years (SD = 8.9), 80.1% were males and 20.9% had diabetes. The mean HbA1c% was 5.9% (SD = 0.9; range = 4.6%-12.8%). The PA questionnaire classified 15.1% of the participants as mostly sedentary, 43.6% engaged in light PA, 33.2% engaged in moderate PA and 8.1% engaged in high levels of PA (Figure 1). An analysis of variance revealed a significant difference in mean HbA1c% values between groups F(3, 343) = 8.56, p &amp;lt; 0.001. Post-hoc comparisons showed that the mean HbA1c% of the least active individuals (M = 6.4%, SD = 1.5) was significantly higher than in all other groups. However, there were no significant group differences between those who engaged in light PA (M = 5.8%, SD = 0.7), moderate PA (M = 5.8%, SD = 0.6) and high levels of PA (M = 5.7%, SD = 0.8), (Figure 2). Conclusion PA was associated with small benefits in glycemic control among individuals with CHD. These findings emphasize the importance of PA in the treatment and management of CHD, and indicate that even small amounts of PA may be of value.Figure 1:Distribution of PA levelsFigure 2:HbA1c% according to PA level L

Diabetes Technology and Therapy in the Pediatric Age Group.

Diabetes Technology and Therapy in the Pediatric Age Group.

A Study of Some Biochemical Parameters in COVID-19 Patients with Diabetes Mellitus: Comparative Study

COVID-l9 is considered a global health emergency, this disease affects all individuals and its symptoms are similar to the common cold. The purpose of this study is to compare diabetic and non-diabetic patients in some biochemical tests of patients infected with COVID-l9. Of the l20 patients included in the study, 7l patients were males (59.l7%) and 49 were females (40.83%). The study showed that the highest percentage was in males with diabetes (63.33%), followed by non-diabetics (55.00%), without significant difference. As for the age group, most patients were over 50 years, and it was most common among non-diabetics in addition to diabetes. Mean glucose was significantly different between the diabetic group and the non-diabetic group. For the diabetic group, the mean blood sugar was 229.22 ± 82.25mg/dl, while the mean blood sugar in the non-diabetic group was l32.25 ± 44.08 mg/dl. In addition, there was a significant difference in mean HbA1c between the diabetic and non-diabetic groups p &lt; .001. For the diabetic group, the mean HbA1c was 7.5l ± l.27 %, but in the non-diabetic group, the mean HbA1c was 5.41 ± 0.73%. While there was a significant difference between the two groups with and without diabetes in the mean ferritin ratio p &lt; .00l. For the diabetic group, the mean serum ferritin was 638.78 ± 327.78 ng/ml, although in the non-diabetic group, the mean serum ferritin was 393.74 ± 330.83 ng/ml. There were no significant differences between the diabetic and non-diabetic group in the mean of D-dimer, urea, creatinine and uric acid, in the diabetic groups, the mean was 6.00 ± 5.80 ug/ml, 86.02 ± 64.27 mg/dl, 1.64+1.45mg/dl and 5.37 ± 3.11mg/dl, respectively. While in the non-diabetic group, the mean was 5.82 ± 5.76 ug/ml, 74.68 ± 68.27mg/dl, 1.88 ± 2.62 mg/dl, and 4.86 ± 2.62 mg/dl, respectively.

Dose-dependent efficacy and safety of licogliflozin on obese adults: A systematic review and meta-analysis of randomized controlled trials

Background and aimLicogliflozin is a dual SGLT1/2 inhibitor acting on the intestine and kidney by reducing glycemic and calorie content. We aimed to determine the efficacy and safety of licogliflozin on Anthropometric measurements and cardiometabolic parameters in obese participants. MethodsWe systematically searched the PubMed, Cochrane Library, Scopus, and Web of Science databases for randomized controlled trials (RCTs) relevant to our eligibility criteria. We performed a subgroup analysis based on licogliflozin doses and the diabetic state of participants. This meta-analysis was registered on PROSPERO (CRD42021286936). ResultsWe identified five RCTs with a total of 905 obese and overweight participants. All participants had a weight reduction of 2.43 kg (95% CI: −3.17 to −1.69, p < 0.00001) compared with placebo. The mean difference in HbA1c of obese diabetic patients was (MD: −0.30%; 95% CI: −0.45, −0.16); I2 = 46% in favor of licogliflozin. The incidence of serious adverse events, all-cause mortality, headache, nausea, and vomiting were similar between licogliflozin and placebo (p = 0.72, 0.97, 0.09, 0.53, and 0.89, respectively). However, there was a higher incidence of diarrhea in the licogliflozin group. ConclusionWe found that licogliflozin was safe and tolerable. It reduces body weight significantly. Moreover, it improves glycemic control and other cardiometabolic parameters.

Implementation of Chronic Care Model for Diabetes Self-Management: A Quantitative Analysis

Objective: The main aim of this study was to implement the Chronic Care Model (CCM) for the self-management of type 2 diabetes in primary health care settings of rural areas of Pakistan and identify its effectiveness and develop strategies for overcoming its challenges. The two core elements of the Chronic Care Model: patient Self-Management Support (SMS) and Delivery System Design (DSD), were implemented to improve the quality of life and risk behaviour of type 2 diabetes patients in the middle-aged population of rural Pakistan. Methods: Thirty patients with type 2 diabetes and 20 healthcare professionals were included in this study consisting of 10 general practitioners and 10 nurses recruited from various clinics (medical centres) of Al-Rehman Hospital in Abbottabad, Pakistan. The quantitative content analysis method was used to identify the frequency of the most recurring statements. A t-test was performed to see the mean difference of HbA1c at baseline after 3-months and 6-months follow-up between male and female patients with diabetes. The hypothesis was tested to identify that diabetes self-management has a gendered dimension in rural areas of Pakistan. Results: The quantitative analysis demonstrated that diabetes self-management has a gendered dimension in the rural areas of Pakistan as the mean difference of HbA1c after a 6-month intervention of the two components of the chronic care model between male and female patients of diabetes was 0.83 (p = 0.039) with 95% CI (−0.05; −1.61). The mean difference in BMI after the intervention of 6 months between males and females was significant (p &lt; 0.05). The mean difference was 4.97 kg/m2, p = 0.040 with 95% CI (−0.24; −9.69). The results have shown that the two components of CCM were effective and improved clinical outcomes for diabetes patients of the rural areas of Pakistan. Conclusions: The application of the two Chronic Care Model’s components provided a viable structure for diabetes self-management education and assistance. As a result, developing systems that incorporate long-term diabetes self-management education has an effect on the health care system’s outcomes.

Qatar Diabetes Mobile Application Trial (QDMAT): an open-label randomised controlled trial to examine the impact of using a mobile application to improve diabetes care in type 2 diabetes mellitus—a study protocol

BackgroundMobile health (mHealth) is increasingly advocated for diabetes management. It is unclear if mobile applications are effective in improving glycaemic control, clinical outcomes, quality of life and overall patient satisfaction in patients with type 2 diabetes (T2DM). A new mobile application was specifically built for people with T2DM with the help of the local expertise. The objective of the study was to evaluate the effectiveness of the mobile app.MethodsThe planned study is an ongoing open-label randomised controlled trial in which adults living with T2DM treated with insulin will be randomised 1:1 to the use of this diabetes application versus current standard care. The primary outcome will be the difference in mean HbA1c from baseline to 6 months. Other outcome measures include anthropometric measures, hypoglycaemic events, medication adjustments, number of clinical interactions and missed appointments and patient perceptions of their disease and diabetes self-management. The study will randomise 180 subjects for assessment of the primary outcome.DiscussionWe hypothesise that the diabetes-specific mobile application will improve glycaemic control, increase patient empowerment for self-management of diabetes and improve interaction between patients and healthcare providers. If the Qatar Diabetes Mobile Application Trial (QDMAT) demonstrates this, it will inform clinical services for the future self-management of T2DM.Trial registrationClinicalTrials.gov Identifier: NCT03998267. Registered on 26 June 2019

1433-P: Comparative Weight Loss with GLP-1 Receptor Agonists vs. Bariatric Surgery in Obesity: A Systematic Review and Pair-Wise Meta-analysis

Background: One in three adults suffers from obesity.1 Glucagon-like peptide-1 (GLP-1) receptor agonists have been associated with 15-20% weight loss, a range previously only achieved with bariatric surgery.2,3,4 This systematic review and meta-analysis compares weight loss between GLP-1 receptor agonists and bariatric surgery. Methods: MEDLINE, Medline-in-Process, Medline EPUBS Ahead of Print, EMBASE Classic + EMBASE (OvidSP) ; and Cochrane (Wiley) databases were searched from inception to April 21, 2021. We included randomized controlled trials (RCTs) and observational studies. Two independent reviewers extracted data, reported risk of bias, and graded certainty of evidence. Risk of bias was reported using Risk of Bias 2 (RoB 2) tool for RCTs and Risk of Bias in Non-randomized Studies- of Interventions (ROBINS-I) tool for observational studies. Data were pooled separately for RCTs and observational studies using random effects models. Change in weight, body mass index (BMI) , and glycated hemoglobin (HbA1C) were summarized. Results: Seven included studies encompassed 11patients. Among RCTs, mean difference in weight between bariatric surgery and GLP-1 receptor agonist was −22.68 (95% CI: −31.41, −13.96) , mean difference in BMI was −8.18 (95% CI: −11.59, −4.77) , and mean difference in HbA1C was −1.28 (95% CI: −1.94, −0.61) . Among observational studies, mean difference in weight was −16.56 (95% CI: −36.53, 3.42) and mean change in BMI was −10.60 (95% CI:−17.22, −3.98) . These effects all favoured bariatric surgery. Conclusion: In adults with obesity, bariatric surgery still confers highest reductions in weight and BMI compared to GLP-1 receptor agonists, but similar effects in glycemic control. Word count: 248 Disclosure P. Palcu: None. Funding Clinician Investigator Program, University of Toronto

974-P: Implementation of Remote Continuous Data Monitoring within a Clinical Setting for the Management of Type 2 Diabetes Mellitus

Introduction: The challenge of managing type 2 diabetes mellitus is well known and was especially highlighted during the pandemic. Advances in the use of technology have resulted in improved glycemic control. The GluCare program uses Remote Continuous Data Monitoring (RCDM) and leverages connectivity and shifting diabetes management away from episodic care to continuous care. Methods and Analysis: Forty type 2 DM patients were managed, with half opting "in" to monitoring using the GluCare RCDM program and half opting "out" to not be monitored. Data was collected from electronic medical reports and statistical analysis was conducted to compare clinical parameters between groups. Outcomes: The primary outcome was the difference in mean HbA1c at 3 months follow-up between Glucare opt-in and opt-out patients with both groups managed by the same health care professional and facility. Secondary outcomes included analysis of body mass index (BMI) , LDL cholesterol, HDL cholesterol, triglycerides (TG) , uric acid, high-sensitivity C-reactive protein and cardiovascular disease (CVD) risk reduction. Results: According to our findings, HbA1c levels from the opt-in RCDM group decreased significantly by a mean of 2.38 points and were statistically superior than the opt-out group (p &amp;lt; 0.001) . The improvements in BMI, TG, and CVD risk reduction also were higher in opt-in patients (p =0.046, p=0.018, p=0.001, respectively) . Conclusion: The GluCare RCDM opt-in group had significantly superior results in HbA1c and other metabolic parameters at 3 months follow up suggesting RCDM post first visit may be an efffective way to improve diabetes care models. Disclosure M.Caccelli: Speaker's Bureau; Novo Nordisk, Servier Laboratories. Y.Said: None. J.D.Mojado: None. C.Palsky: None. R.Colodetti: None. I.Almarzooqi: None. A.Hashemi: None.

593-P: Similar Rate of Positive Depression Screen in Youth with Diabetes Before and During the COVID-Pandemic: Still No Reason for Complacency

Adolescents with diabetes mellitus (DM) experience depression 2-3 times higher than the general population. Little is known about the impact of the COVID pandemic. We aimed to identify the prevalence of depression among youth with DM before and during the pandemic and associated factors in a large academic children’s hospital. Patient health Questionnaire-9 (PHQ-9) screens completed in fall 20 and 2020 (n=216 vs. 194 respectively) were reviewed. 187 subjects (81%) completed the screen at both periods (54% female, 97% white, 97% with type 1 DM (T1D) , mean (SD) age 15.1 (2.7) years, duration of DM 7.2 (4.2) years) . Among youth with T1D, 55% used insulin pumps and 64% continuous glucose monitor (CGM) . When comparing 20to 2020, median [IQR] PHQ-9 score (1 [0-3] vs. 0 [0-3], p=0.76) or rates of depression (17 vs. 15%, p=0.65) were not different. In 2011%, 4% and 2% had mild (PHQ-9 score 5-9) , moderate (score 10-14) , and severe (score &amp;gt;14) depression respectively with similar rates in 2020 at 10%, 2% and 3% There was no difference in mean HbA1c between 20 and 2020 (8.2±1.7 vs. 8.2± 1.8% respectively, p=0.99) . Using 20data, PHQ-9 score was significantly positively correlated with HbA1c (rho=0.22, p=0.003) and BMI z-score (rho=0.22, p=0.003) , but not to age (rho-0.02, p=0.73) , or duration of diabetes (rho=0.04, p=0.55) . Depression was more prevalent in females (21% vs. 12%, p=0.09) and in youth with no CGM use (24 vs. 12%, p=0.047) . Suicidal ideation was reported in 4 (2%) of youth in 20 and 3 (1.5%) in 2020. Our results suggest that the prevalence/severity of depression during the first year of the pandemic did not change in youth with DM compared to the previous year, the reason perhaps being that ∼ 90% of patients in our institution continued to being followed up, albeit virtually, during the pandemic. Still, almost 1/5 of adolescents with DM scored positive for depression highlighting the need to support the behavioral needs of youth with T1D. Disclosure S.Sriram: None. L.M.Leikam: None. C.March: None. J.Schreiber: None. R.Muzumdar: None. I.Libman: Consultant; Novo Nordisk.

IDF21-0072 Safety and Efficacy of Insulin IGlarLixi versus IDegLira: A Meta-Analysis of Fifteen studies

Background: Combination of insulin and a GLP-1 analogue in a fixed-ratio, the once-daily injection has a promising beneficial clinical base on efficacy and safety, besides GLP-1 affects weight loss and cardiovascular protection. Up to now, there is no head-to-head comparison between IDeglira and IGlarLixi. Aim: This meta-analysis intends to evaluate clinical studies regarding assess efficacy and safety between IGlarLixi versus IDegLira indirectly comparative. Method: The eligible publication was screened using inclusion criteria such as 1) the study included minimal one month follow up; 2) be compared to a control group; 3) carried by the English language; 4) published at least from 2010, and; 5) clinical study that reached phase 1 until phase 3. Any situation which altered endocrinologic status, abstracts only, case reports, letters, comments, or reviews; animal studies; duplicate studies; no surgical intervention; and no population of interest, and receipt of any investigational product within 30 days before screening was set as exclusion criteria. Studies were searched using keywords: (IGlarLixi) OR (IDegLira) AND (Diabetes Mellitus) in several databases of Cochrane Central Register of Controlled Trials (CENTRAL), Pubmed, ClinicalTrials.gov, EMBASE. All papers were reviewed using critical appraisal for clinical trials by Centre for Evidence-Based Medicine Oxford University. The risk of bias was determined by the Cochrane Handbook by Cochrane Handbook for a randomized trial. Seventy papers were initially collected using PICO in advanced search, 20 are duplicated, and 35 articles did not fulfil the criteria. Fifteen clinical trials (Lixilan and DUAL trial) were pooled and entered into review manager 5.4 and Graph Prism 8. [1,2,11–15,3–10] The primary endpoint was the mean difference in HbA1c and Fasting plasma glucose from baseline in each group; secondary efficacy endpoints were risk ratio of achievement of end-of-trial HbA1c of less than 7.0% and several participants without weight gain at the end of the trial. Safety variables included severe, non-serious adverse, and hypoglycaemic events. Results: Fifteen RCTs were identified using a total of 9896 T2DM patients i.e;5509 intervention and 4389 control. The baseline data of mean age respectively Lixilan vs DUAL in each case and control group was 58.2 ±1.92;58.2 ±1.92 in Lixilan Trial, while in DUAL trial 58.2 ±1.92 and 58.2 ±1.92; duration of diabetes 9.97±1.51; 10.2± 1.34 vs 9.46±2.13; 9.6±2.08 years, HbA1C (%) 8.11± 0.108; 8.09±0.12 vs 8.24±0.06;8.25±0.31; Fasting plasma glucose (mmol/L) 8.5±1.03; 8.52±1.03 vs 9.29±0.49; 9.39±0.56. Primary endpoint such as a decrease in HbA1c, FPG level, the proportion of HbA1c < 7%, and patient without weight gain was not different as statically with p=0.32;0,29,0.34;0.95. The safety endpoint showed the same result. Severe hypoglycaemia was 1.06 (0.48, 2.34). Discussion: Limitations: The assumptions made in the indirect comparison and differences between the included trials in efficacy and safety endpoint. Conclusion: These results, either efficacy and safety endpoint showed no statistically significant differences between IGlarLixi and IDegLira, and both states promising beneficial clinically with equal evidence.

Effect of Digital Lifestyle Management on Metabolic Control and Quality of Life in Patients with Well-Controlled Type2 Diabetes.

IntroductionThe lack of effective, scalable solutions for lifestyle treatment is a global clinical problem, causing severe morbidity and mortality. Digital tools could enable broad utility, but long-term metabolic outcomes and the influence on quality of life are unclear.MethodsWe developed a new method for lifestyle treatment that promotes self-reflection and iterative behavioural change, provided as a digital tool, and evaluated its effect on glycaemic control in patients with type 2 diabetes with HbA1c below 52 mmol/mol (n = 297). As a secondary analysis, its effect on quality of life (using SF-12) was examined in both participants with and without diabetes (total n = 1914). The tool was evaluated during a 12-week randomization period to assess the existence of effect, with a subsequent open-label follow-up to study long-term outcomes.ResultsParticipants were randomized to wait or access the intervention tool. The mean difference in HbA1c was 2 mmol/mol (95% CI − 4 to 0; P = 0.02) after 12 weeks in participants with type 2 diabetes. The groups were then merged to enable all participants to use the tool. The mean HbA1c reduction from baseline in patients with type 2 diabetes using the tool was 2 mmol/mol compared with matched controls (95% CI − 3 to 0; P = 0.005). In users with HbA1c above 45 mmol/mol, the mean difference between the groups was 4 mmol/mol (95% CI − 7 to − 2). The improvements were sustained during the follow-up of 1 year on average. Users of the tool also had improved quality of life from baseline to 6 months, mainly observed in non-diabetic participants.ConclusionThe tool does not require in-person reinforcement or increased healthcare resources, and the marginal cost is fundamentally lower than pharmacological treatment and most existing lifestyle interventions. The results therefore open a new means for self-managed lifestyle treatment with long-term metabolic efficacy that can benefit large numbers of people.Trial RegistrationClinicalTrials.gov NCT04624321 and NCT05006508.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-022-01214-2.

The Effectiveness of Telemedicine Solutions in Type 1 Diabetes Management: A Systematic Review and Meta-analysis.

Telemedicine holds a potential to strengthen self-management support outside health care settings in the everyday management of type 1 diabetes (T1D). However, existing effectiveness reviews are older or include a relatively narrow focus on specific definitions of telemedicine or included databases. To conduct a systematic review of the effectiveness of telemedicine solutions versus any comparator on diabetes-related outcomes among people with T1D. Studies including adults (≥18 years) with T1D published before October 14, 2020, were eligible. Primary outcome was glycated hemoglobin (HbA1c, %). The Cochrane Library, PubMed, EMBASE, and CINAHL were searched. Meta-analysis based on the mean difference in HbA1c% was used to pool effects. The Cochrane tool was applied to assess risk-of-bias, and the certainty of evidence was graded using the GRADE approach. A total of 22 studies were included (with 1615 participants). Treatment effect for HbA1c% favored telemedicine (mean difference of -0.26% [95% confidence interval:-0.37% to -0.15%]) with moderate effect certainty. Heterogeneity was moderate (I2 = 33.30%). Although not significant, secondary outcomes were all in favor of telemedicine except number of severe hypoglycemic events and diabetes knowledge, but the certainty of the evidence for those outcomes was all low or very low. Reducing average HbA1c% levels are important to combat the risk of diabetic complications and premature death. However, the evidence mostly consist of small studies with a relative short duration and the estimated pooled effect is smaller than could be expected from quality improvement strategies in general for diabetes management. CRD42020123565.

Randomized controlled study to evaluate the impact of flexible patient-controlled visits in people with type 1 diabetes: The DiabetesFlex Trial.

The objective of this study was to assess the impact of health care-initiated visits versus patient-controlled flexible visits on clinical and patient-reported outcomes in people with type 1 diabetes. The DiabetesFlex trial was a randomized controlled, pragmatic non-inferiority 15-month follow-up study comparing standard care (face-to-face visits every 4months) with DiabetesFlex (patient-controlled flexible visits using patient-reported, outcome-based telehealth follow-up). Of 343 enrolled participants, 160 in each group completed the study. The primary outcome was mean change in HbA1c from baseline to 15-month follow-up. Secondary outcomes were blood pressure, lipid levels, frequency of visits, the World Health Organization score-five well-being-index (WHO-5), the Problem Areas In Diabetes (PAID) scale and experience of participation in own care (participation score). The adjusted mean difference in HbA1c between standard care and DiabetesFlex was similar and below the predefined non-inferiority margin of 0.4% (-0.03% [95%CI: 0.15, 0.11]/-0.27mmol/mol [-1.71, 1.16]). No intergroup mean changes in lipid or blood pressure were observed. Conversely, DiabetesFlex participants presented an increased mean WHO-5 index of 4.5 (1.3, 7.3), participation score of 1.1 (0.5, 2.0), and decreased PAID score of -4.8 (-7.1, -2.6) compared with standard care. During follow-up, DiabetesFlex participants actively changed 23% of face-to-face visits to telephone consultations, cancelled more visits (17% vs. 9%), and stayed away without cancellation less often (2% vs. 8%). Compared with standard care, flexible patient-controlled visits combined with patient-reported outcomes in participants with metabolic controlled type 1 diabetes and good psychological well-being further improved diabetes-related well-being and decreased face-to-face visits while maintaining safe diabetes management.