Differences In Glycemic Control Research Articles

Impact of Vitamin D Supplementation on Glycaemic Control in Type 2 Diabetes Patients: A Double Blind Randomized Controlled Trial

Introduction: Vitamin D deficiency is a global health concern affecting diverse populations and it has been linked to various ailments. This study aimed to investigate vitamin D levels among T2DM patients and evaluate the impact of supplementation on those deficient, alongside its effect on quality of life and comorbidities. Methodology: A double-blinded randomized controlled trial was conducted among T2DM patients aged 18-75 years with HbA1c ≥ 7% and vitamin D deficiency (<12 ng/mL). Participants were divided into intervention (vitamin D supplementation) and control (placebo) groups. Data on demographics, diabetic status, and comorbidities were collected. Blood samples were analyzed for HbA1c and Vitamin D levels. Results: Of the 66 participants initially recruited, 60 completed the study. No adverse effects were observed. There was no significant difference in glycemic control between the intervention and control groups at 3 and 6 months. Quality of life showed no significant improvement with supplementation. Conclusion: This study did not find evidence supporting the efficacy of vitamin D supplementation in improving glycemic control or quality of life among T2DM patients with vitamin D deficiency. Further research is warranted to explore alternative interventions or factors influencing glycemic control and quality of life in T2DM patients.

Impact of Gliclazide Modified Release or Glimepiride as Add-on Therapy to Metformin on Glycemic and Oxidative Stress Parameters in Type 2 Diabetic Patients

Background: Type 2 diabetes mellitus is a condition characterized by an elevation of oxidative stress, which has been implicated in diabetic progression and its vascular complications. Aim: Assessing the impact of gliclazide modified release (MR) versus glimepiride on oxidative stress markers, glycemic indices, lipid profile, and estimated glomerular filtration rate in uncontrolled type 2 diabetic patients on metformin monotherapy. Methods: This was an observational comparative study conducted in Thi-Qar specialized diabetic, endocrine, and metabolism center. Sixty-six patients were randomized into two groups based on the addition of the sulfonylureas (SUs). Group 1 (33 patients) was on gliclazide MR, whereas Group 2 (33 patients) was on glimepiride. The measured oxidative stress markers were reduced glutathione (GSH), superoxide dismutase (SOD), malondialdehyde (MDA), and protein carbonyl (PC) evaluated before and after 16 weeks of SUs addition. Results: There were significant drops in SOD (P < 0.001), MDA (P < 0.001), and PC (P = 0.001) and a significant increase in GSH (p = 0.029) levels after gliclazide MR add-on therapy. There were significant drops in SOD (P = 0.026) and MDA (P < 0.001) levels with non-significant changes in both GSH (P = 0.214) and PC (P = 0.538) after glimepiride add-on therapy. There was a significant difference in improvement of PC level (P = 0.048) in the gliclazide group compared to the glimepiride group, with a non-significant numerically higher improvement of GSH, SOD, and MDA in gliclazide MR than glimepiride. At the end of the study, there were no significant differences in glycemic control, lipid profile, or eGFR improvement between the two groups. Conclusion: Glycemic control plays a pivotal role in decreasing oxidative stress. The control of diabetes with the gliclazide-MR-metformin combination reduced oxidative stress more than the glimepiride-metformin combination, indicating its antioxidant property. Keywords: Oxidative Stress, T2DM, Gliclazide MR, Glimepiride, Metformin.

The effect of cognitive behavioral therapy for insomnia on sleep and glycemic outcomes in people with type 2 diabetes: A randomized controlled trial

Study objectivesInvestigate whether aiding sleep by online cognitive behavioral therapy for insomnia (CBT-I) can improve glycemic and metabolic control, mood, quality of life (QoL) and insomnia symptoms in people with type 2 diabetes and assess the mediating role of lifestyle factors. MethodsAdults with type 2 diabetes and insomnia symptoms were randomly assigned to CBT-I or care as usual. At baseline, three and six months we assessed HbA1c as primary outcome and glycemic control, metabolic outcomes, sleep, mood and QoL as secondary outcomes. Mixed models were used to determine within-person and between-persons differences in outcomes and mediation analysis for lifestyle factors. ResultsWe randomized 29 participants to CBT-I and 28 to care as usual. Intention-to-treat analysis showed no significant differences in glycemic control, metabolic outcomes, anger, distress or QoL, but showed a significantly larger decrease in insomnia (−1.37(2.65: 0.09)) and depressive symptoms (−0.92(-1.77: 0.06)) and increase in BMI (0.29 kg/m2(0.00:0.57)) in the intervention compared to the control group. Only half of the intervention participants completed the CBT-I. Per protocol analysis showed a not statistically significant decrease in HbA1c (−2.10 mmol/l(-4.83:0.63)) and glucose (−0.39 mmol/l(-1.19:0.42)), metabolic outcomes and increase in QoL. Furthermore, the intervention group showed a significant decrease in insomnia (−2.22(-3.65: 0.78)) and depressive symptoms (−1.18(-2.17: 0.19)) compared to the control group. Lifestyle factors partially mediated the effect of the intervention. ConclusionsCBT-I might improve insomnia symptoms and mood, and perhaps improves glycemic control, albeit not significant, in people with type 2 diabetes and insomnia symptoms, compared to care as usual.

The effect of closed-loop glucose control on C-peptide secretion in youth with newly diagnosed type 1 diabetes: the CLOuD RCT

Background We assessed whether a sustained period of intensive glucose control with hybrid closed-loop for 12 months following diagnosis of type 1 diabetes in children and adolescents can preserve C-peptide secretion compared to standard insulin therapy. Methods In an open-label, multicentre, randomised, parallel trial, youth aged 10–16.9 years were randomised within 21 days of type 1 diabetes diagnosis to hybrid closed-loop or standard insulin therapy (control). Primary end point was the difference in mixed-meal C-peptide area under the curve 12 months post diagnosis. Key secondary end points included time spent in target glucose range, glycated haemoglobin and time spent below target glucose range at 12 months. Analysis was by intention to treat. The Closed Loop from Onset in Type 1 Diabetes consortium secured external funding for participants to continue on beyond 12 months, but the funding by National Institute for Health and Care Research and the results reported here refer only to the 12 months follow-up. Results We randomised 97 participants (mean ± standard deviation age 12 ± 2 years), 51 to closed-loop and 46 to control therapy. There was no difference in C-peptide area under the curve at 12 months between groups [geometric mean (interquartile range) closed-loop (n = 46): 0.35 pmol/ml (0.16, 0.49) vs. control (n = 37): 0.46 pmol/ml (0.22, 0.69); mean adjusted difference –0.06 (95% confidence interval –0.14 to 0.03); p = 0.19]. The proportion of time in target range 3.9–10.0 mmol/l based on 14-day masked LibrePro (Abbott Diabetes Care, Maidenhead, UK) sensor glucose data at 12 months was 10 percentage points (95% confidence interval 2 to 17) higher in the closed-loop group (64 ± 14%) compared to control group (54 ± 23%). Arithmetic mean glycated haemoglobin A1c was lower in the closed-loop group by 4 mmol/mol (0.4%) [95% confidence interval 0 to 8 mmol/mol (0.0% to 0.7%)] at 12 months. The mean difference in time spent < 3.9 mmol/l between groups was 0.9 percentage points (95% confidence interval –1.0 to 2.8). Three severe hypoglycaemic events occurred in the closed-loop group (two participants), and one in the control group; one diabetic ketoacidosis occurred in the closed-loop group. Conclusions A sustained period of hybrid closed-loop glucose control following diagnosis of type 1 diabetes in children and adolescents does not slow down the decline in residual C-peptide secretion compared with standard insulin therapy. Despite the lack of effect on C-peptide, glycaemic control was sustained in the closed-loop group, whereas glycaemic control deteriorated in the control group 6 to 9 months after diagnosis and closed-loop safely accommodated the variability in exogenous insulin requirements which occur with beta-cell recovery post diagnosis. Limitations of the study included no central measurement of auto-antibodies at diagnosis. There was imbalance in the rate of diabetic ketoacidosis at diagnosis which is associated with a more rapid decline in C-peptide secretion, but this was adjusted for in the analyses. This highlights the need for improved therapies to allow youth to achieve recommended glycaemic targets from onset of type 1 diabetes irrespective of the lack of effect on residual C-peptide secretion. Future work includes ongoing follow-up of the study population for up to 4 years after diagnosis to observe how any differences in glycaemic control between treatment groups develop over time. Trial registration This trial is registered as Clinicaltrials.gov NCT02871089. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme (NIHR award ref: 14/23/09), the Helmsley Trust (2016PG-T1D045 and 2016PG-T1D046), and JDRF (22-2013-266 and 2-RSC-2019-828-M-N), and is published in full in Efficacy and Mechanism Evaluation; Vol. 11, No. 8. See the NIHR Funding and Awards website for further award information. Additional support for the artificial pancreas work was from the NIHR Cambridge Biomedical Research Centre and NIHR Oxford Biomedical Research Centre. Abbott Diabetes Care supplied free glucose monitoring devices, and Dexcom supplied discounted continuous glucose monitoring devices. Medtronic supplied discounted insulin pumps, phone enclosures, continuous glucose monitoring devices, and pump consumables.

Glycaemic control among adults with type 2 diabetes mellitus in the Gulf Cooperation Council countries: an updated review.

Type 2 diabetes mellitus (T2DM) has become a major public health concern, causing significant disability and death worldwide. Fuelled by a modern sedentary lifestyle and poor dietary practices, T2DM affects at least 10.5% of the world's population. This paper seeks to review the progress made by the Gulf Cooperation Council (GCC) countries (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates) in addressing T2DM, focusing on glycaemic control proportions and comparing it with the 2015 review. The results indicate no significant improvement in glycaemic control proportions since the last review, with only 9.2% to 56.9% of patients having good control (glycosylated haemoglobin < 7%). However, there are no significant differences in glycaemic control between the GCC countries and other places worldwide despite being considered hotbeds of T2DM. Many factors contribute to poor glycaemic control. Specifically, evidence shows that being overweight or obese is the most common modifiable risk factor for T2DM incidence and poor glycaemic control. The GCC countries have higher rates of obesity. Additionally, poor glycaemic control is mainly related to a lack of adherence to insulin and medication use. Poor diet, rich in calories and low in fruits and vegetables, and a sedentary lifestyle also significantly contribute to poor glycaemic control and obesity. Therefore, to reduce the incidence of disease and improve glycaemic control in diabetic patients, educational programs promoting lifestyle changes should be implemented. Ongoing research is also necessary to assess the trend of glycaemic control and its risk factors in our region.

Differences in Glycemic Control for Inpatients with Type 1 Diabetes on Insulin Pump Versus Subcutaneous Insulin Therapy.

Inpatient use of insulin pump therapy has been increasing due to greater availability of this technology, however there is a paucity of research that investigates glycemic control of inpatient insulin pump users. To compare the glycemic control of hospitalized patients with type 1 diabetes (T1D) who used insulin pump vs. multiple daily injections(MDI). Retrospective chart review. Patients with T1D who were hospitalized between January 1, 2017, and December 31, 2019, in an academic medical center in the New York metropolitan area. Patients were categorized into three groups based on their method of insulin administration: "pump only" groupused insulin pump exclusively, "MDI only" group used MDI only, and "intermittent pump" group used a combination of both methods. The primary endpoints are mean blood glucose, rates of hypoglycemic events (blood glucose < 70mg/dL), and rates of hyperglycemic events (blood glucose > 250mg/dL).Separate multivariable Poisson regressions were performed to determine the association between the type of insulin administration and rate outcomes (i.e., rate of hypoglycemic events and rate of hyperglycemic events). The study included 78 patients with a mean age of 51, who were mostly male (54%), and white (72%). The average proportion of glucose measurements that were hyperglycemic for the "pump only", "MDI only", and "intermittent pump" groups were 0.11 (SD = 0.11), 0.25 (SD = 0.19), and 0.24 (SD = 0.25), respectively. The "pump only" group has a significantly lower proportion of hyperglycemic events as compared to the "MDI only" group (p = 0.0227). In this sample, patients who exclusively used their insulin pump while inpatient had a lower rate of hyperglycemic events than patients who used MDI only; suggesting that select patients can safely continue their insulin pump therapy in the inpatient setting.

Are all sugars equal? Role of the food source in physiological responses to sugars with an emphasis on fruit and fruit juice.

High (free) sugar intakes can increase self-reported energy intake and are associated with unfavourable cardiometabolic health. However, sugar source may modulate the effects of sugars due to several mechanisms including the food matrix. The aim of this review was to assess the current state of evidence in relation to food source effects on the physiological responses to dietary sugars in humans relevant to cardiometabolic health. An additional aim was to review potential mechanisms by which food sources may influence such responses. Evidence from meta-analyses of controlled intervention trials was used to establish the balance of evidence relating to the addition of sugars to the diet from sugar-sweetened beverages, fruit juice, honey and whole fruit on cardiometabolic outcomes. Subsequently, studies which have directly compared whole fruit with fruit juices, or variants of fruit juices, were discussed. In summary, the sources of sugars can impact physiological responses, with differences in glycaemic control, blood pressure, inflammation, and acute appetite. Longer-term effects and mechanisms require further work, but initial evidence implicates physical structure, energy density, fibre, potassium and polyphenol content, as explanations for some of the observed responses.

Fetal Overgrowth and Preterm Delivery in Women With Type 1 Diabetes Using Insulin Pumps or Multiple Daily Injections: A Post Hoc Analysis of the EVOLVE Study Cohort.

To compare the risk of fetal overgrowth and preterm delivery in pregnant women with type 1 diabetes (T1D) treated with insulin pumps versus multiple daily injections (MDI) and examine whether possible differences were mediated through improved glycemic control or gestational weight gain during pregnancy. The risk of pregnancy and perinatal outcomes were evaluated in a cohort of 2,003 pregnant women with T1D enrolled from 17 countries in a real-world setting during 2013-2018. In total, 723 women were treated with pumps and 1,280 with MDI. At inclusion (median gestational weeks 8.6 [interquartile range 7-10]), pump users had lower mean HbA1c (mean ± SD 50.6 ± 9.8 mmol/mol [6.8 ± 0.9%] vs. 53.6 ± 13.8 mmol/mol [7.1 ± 1.3%], P < 0.001), longer diabetes duration (18.4 ± 7.8 vs. 14.4 ± 8.2 years, P < 0.001), and higher prevalence of retinopathy (35.3% vs. 24.4%, P < 0.001). Proportions of large for gestational age (LGA) offspring and preterm delivery were 59.0% vs. 52.2% (adjusted odds ratio [OR] 1.36 [95% CI 1.09; 1.70], P = 0.007) and 39.6% vs. 32.1% (adjusted OR 1.46 (95% CI 1.17; 1.82), P < 0.001), respectively. The results did not change after adjustment for HbA1c or gestational weight gain. Insulin pump treatment in pregnant women with T1D, prior to the widespread use of continuous glucose monitoring or automated insulin delivery, was associated with a higher risk of LGA offspring and preterm delivery compared with MDI in crude and adjusted analyses. This association did not appear to be mediated by differences in glycemic control as represented by HbA1c or by gestational weight gain.

SAT096 Disparities Associated With Technology Use And Diabetes Control In A Minority Cohort Of Children And Adolescents

Abstract Disclosure: A. Granados: None. D. Baboun: None. R. Alvarez-Salvat: None. A. Martinez Sanchez: None. A. Carrillo: None. Background: Children and adolescents of racial and ethnic minorities exhibit suboptimal glycemic control and have the lowest rates of diabetes technology use. The utilization of technology has been found to improve overall diabetes control in children and adolescents. Objective: The purpose of this study is to determine whether technology use impacts diabetes control in a minority cohort of children and adolescents with either type 1 or type 2 diabetes. Methods: A retrospective study was conducted among a minority cohort of children and adolescents with diabetes seen at a multidisciplinary clinic. Data were collected from January to November of 2022. Patients who used their continuous glucose monitors (CGMs) and/or insulin pumps were categorized as technology users, whereas patients who did not were categorized as non-technology users. Demographic data, glycated hemoglobin (HbA1C) levels, BMI z-scores, LDL levels, and psychological functioning scores (PHQ-9 and DEPS-R) were collected for all participants during clinic visits. Chi-squared and t-tests were performed to compare all collected data according to device use. Results: We analyzed data from 170 children and adolescents with diabetes. Of the 170 patients, 125 (73.53%) were Hispanic, 7 (4.12%) were Non-Hispanic White, and 39 (22.94%) were Black; 85 (50.00%) were female; and the age range was 4-20 years (mean 13.62 ± 3.33). Of the 165 patients who had health insurance, 124 (75.15%) were publicly insured, and 41 (24.85%) were privately insured. Large racial-ethnic disparities in technology use existed, as 95 (76.00%) Hispanics, 5 (71.43%) Non-Hispanic Whites, and 20 (51.28%) Blacks were categorized as technology users (p = 0.007). There was no difference between the HbA1C levels of technology users (9.1%) and non-technology users (9.4%) (p = 0.6). The BMI z-score was lower in technology users (0.33) than in non-technology users (1.39) (p = 0.05). Likewise, LDL levels were lower in technology users (93.80 mg/dl) than in non-technology users (108.53 mg/dl) (p = 0.05). There was no significant difference in PHQ-9 and DEPS-R between the groups. Conclusions: The results provide novel insights into the impact of technology in diabetes control in a minority cohort of children and adolescents. Despite the high overall rate of technology use, there was no significant difference in glycemic control between technology users and non-technology users. This finding suggests that the utilization of diabetes technology may not be correlated with better glycemic control in minority groups. However, BMI z-scores and LDL levels were lower in technology users. Further research is needed to determine the root causes of disparities in diabetes control in children and adolescents of racial and ethnic minorities. Presentation: Saturday, June 17, 2023

Comparison of Glycemic Control Between In-Person and Virtual Diabetes Consults in Hospitalized Patients With Diabetes.

There is limited evidence that the diabetes in-person consult in hospitalized patients can be replaced by a virtual consult. During COVID-19 pandemic, the diabetes in-person consult service at the University of Miami and Miami Veterans Affairs Healthcare System transitioned to a virtual model. The aim of this study was to assess the impact of telemedicine on glycemic control after this transition. We retrospectively analyzed glucose metrics from in-person consults (In-person) during January 16 to March 14, 2020 and virtual consults during March 15 to May 14, 2020. Data from virtual consults were analyzed by separating patients infected with COVID-19, who were seen only virtually (Virtual-COVID-19-Pos), and patients who were not infected (Virtual-COVID-19-Neg), or by combining the two groups (Virtual-All). Patient-day-weighted blood glucose was not significantly different between In-person, Virtual-All, and Virtual-COVID-19-Neg, but Virtual-COVID-19-Pos had significantly higher mean ± SD blood glucose (mg/dL) compared with others (206.7 ± 49.6 In-person, 214.6 ± 56.2 Virtual-All, 206.5 ± 57.2 Virtual-COVID-19-Neg, 229.7 ± 51.6 Virtual-COVID-19-Pos; P = .015). A significantly less percentage of patients in this group also achieved a mean ± SD glucose target of 140 to 180 mg/dL (23.8 ± 22.5 In-person, 21.5 ± 20.5 Virtual-All, 25.3 ± 20.8 Virtual-COVID-19-Neg, and 14.4±18.1 Virtual-COVID-19-Pos, P = .024), but there was no significant difference between In-person, Virtual-All, and Virtual-COVID-19-Neg. The occurrence of hypoglycemia was not significantly different among groups. In-person and virtual consults delivered by a diabetes team at an academic institution were not associated with significant differences in glycemic control. These real-world data suggest that telemedicine could be used for in-patient diabetes management, although additional studies are needed to better assess clinical outcomes and safety.

Health-related Quality of Life among Type 2 Diabetes Patients in Southern Province of Saudi Arabia using WHOQOL-BREF: A Cross-section Study.

Quality of life has become a more important health outcome with advancements in medical therapies and disease management, leading to better lives for people in general, particularly those living with chronic diseases. Diabetes has a direct impact on the physical, psychological, and social aspects of personal health. This study aimed to determine healthrelated quality of life (HRQOL) and its predictors in patients with type 2 diabetes. A cross-sectional study was carried out on 420 patients with type 2 diabetes who presented to primary healthcare centers in Samtah Town, Saudi Arabia, from March 2017 to February 2018. The HRQOL of the study participants was determined using the World Health Organization Quality of Life-BREF. Multi-level linear regression was employed to ascertain the factors associated with HRQOL among patients with type 2 diabetes. Female sex was significantly associated with higher HbA1c, anxiety, depression, and stress scores and a lower HRQL in the physical, psychological, and environmental health subscales than males (P<0.001). All subscales of HRQOL were significantly lower in the > 50 years age group. When compared to those with low levels of education (illiterate, primary, or elementary school), patients with secondary and bachelor's degrees had significantly higher HRQOL in all subscales (P<0.001). In addition, there were significant differences in glycemic control and HRQL with a longer duration of diabetes, the presence of one or more diabetes complications, and the presence of comorbid hypertension (P<0.001). However, no significant differences in the Depression Anxiety and Stress Scale (DASS) index were observed with a longer duration of diabetes and the presence of comorbid hypertension. Patients with diabetes on combined therapy and healthy diet and exercise showed significantly higher HRQOL on physical functioning (P<0.001). Type 2 diabetes was significantly associated with impaired health-related quality of life and mental health among study participants. Females appeared to have worse quality of life and mental health than males. Age, duration of diabetes, comorbid hypertension, diabetes complications, and level of education were significantly associated with lower HRQOL and mental health scores. Healthy diet and exercise, when combined with hypoglycemic and insulin therapy, were found to improve HRQOL and mental health among patients with diabetes. Scales based on a broad definition of health, such as the WHOQOL-BREF, are appropriate for use in primary care settings and can enhance patient management and care.

Perbandingan Efektivitas Antara Metformin dan Glimepiride Berdasarkan Kadar Gdp pada Pasien Dm Tipe 2 di Rsud Dr.M.Soewandhie pada Tahun 2019

Diabetes Mellitus is a chronic metabolic disease characterized by elevated blood sugar levels and impaired carbohydrate, lipid, and protein metabolism due to betta pancreatic-cell dysfunction or insulin resistance in body cells. The prevalence of diabetes mellitus continues to increase worldwide. Indonesia itself has a prevalence of type 2 diabetes mellitus reaching 90% of all diabetes (WHO, 2016) (Riskesdas, 2018). The management of type 2 diabetes mellitus is very diverse, ranging from non-pharmacological therapy to pharmacological therapy such as insulin injection and oral anti-diabetes. Each anti-diabetic drug has a variety of ways of working, administration, and side effects. This study aims to analyze the comparison of the effectiveness of anti-diabetic medications based on blood sugar levels from the use of metformin and glimepiride (sulfonylureas) or a combination of both in patients with type 2 diabetes mellitus at Dr. Soewandhie Regional Public Hospital. This research is an analytic retrospective observational using secondary data in the form of medical records of patients with type 2 Diabetes Mellitus (outpatient) at Dr. Soewandhie Regional Public Hospital in 2019. The sample of this study consisted of 121 samples that met the inclusion criteria (43 patients on metformin therapy, 40 patients on glimepiride therapy, and 38 patients on combination therapy). The analysis of this study used data on FBG (Fasting Blood Glucose) before and three months after receiving metformin or sulfonylurea (glimepiride) therapy or a combination of both in the medical record. Data analysis of this study was performed using the Friedman test. This study showed that there was no significant difference in glycemic control (∆FBG) of metformin, glimepiride, and combination therapy in patients with type 2 diabetes mellitus (p value=0.575). There was no significant difference in the effectiveness of metformin, glimepiride, and combination therapy in patients with type 2 diabetes mellitus in Dr. Soewandhie Regional Public Hospital in 2019. In a study conducted in Japan showed that there’s efficacy of high-dose metformin use in patients with type 2 diabetes mellitus in Japan. The efficacy and safety of metformin are similar when used either twice daily or thrice daily. Further research needs to be done to assess the glycemic control (∆FBG) rate of metformin, glimepiride, and combination therapy in patients with type 2 diabetes mellitus by taking into account other factors such as medication adherence, diet, and physical activity.

Achieving comparability in glycemic control between antidiabetic treatment strategies in pregnancy when using real world data.

Healthcare utilization databases often lack information on glycemic control, a key confounder when studying the safety of antidiabetic treatments, since patients with worse control are channeled to second-line agents, in particular insulin, versus first-line agents such as metformin. We evaluated whether adjustment for measured characteristics attains balance in glycemic control when comparing antidiabetic treatment strategies in pregnant women with pregestational type 2 diabetes (T2DM). In a US insurance claims database, we identified 3360 women with T2DM pregnant between 2004 and 2015, of whom a subset of 996 had data on hemoglobin A1c (HbA1c ) levels. We selected insulin only as the comparator group and used propensity score (PS)-matching on comorbidities and proxies of diabetes severity, but not on HbA1c , to adjust for confounding. We used standardized differences (st.diff) to assess balance in claims-based covariates and mean HbA1c (% ± SD) in the subset. There were imbalances in claims-based covariates before PS-matching, with smaller differences when both treatment strategies included insulin. After PS-matching, balance was achieved in most claims-based covariates (st.diff <0.1). Mean HbA1c was similar before and after PS-matching when both treatments included insulin (e.g., 7.1 ± 1.5 vs. 7.7 ± 1.8 and 7.1 ± 1.5 vs. 7.5 ± 1.7, respectively, for metformin + insulin vs. insulin only). Differences in mean HbA1c remained after PS-matching when non-insulin treatments were compared to treatments including insulin (e.g., 6.3 ± 1.1 vs. 7.6 ± 1.7 for metformin only vs. insulin only). Balance in both claims-based characteristics and glycemic control was attained after restricting the population to women with T2DM and comparing treatment strategies indicated for patients with similar diabetes severity. When comparing treatment strategies with versus without insulin, differences in glycemic control persisted after PS-matching even when balance was attained for other measured characteristics.

The impact of pharmacist interventions, follow-up frequency and default on glycemic control in Diabetes Medication Therapy Adherence Clinic program: a multicenter study in Malaysia

BackgroundPharmacist’s involvement in optimizing medication adherence among diabetic patients has been implemented for over a decade. Diabetes Medication Therapy Adherence Clinic (DMTAC) was set up to educate diabetic patients, monitor treatment outcomes, and manage drug-related problems. While evidence shows that pharmacist-led DMTAC was effective in reducing HbA1c, there was limited data regarding the impact of different intervention types and default to follow-up on glycemic control.AimTo assess the impact DMTAC on glycemic control and the difference in glycemic control between hospital and health clinic settings as well as defaulter and non-defaulter. In addition, the impact of pharmacist’s interventions, DMTAC follow-up frequencies, and duration of diabetes on glycemic control were also determined.MethodsA retrospective study was conducted among diabetes patients under DMTAC care between January 2019 and June 2020 in five hospitals and 23 primary health clinics. Patients’ demographics data, treatment regimens, frequencies of DMTAC visits, defaulter (absent from DMTAC visits) and types of pharmacists’ intervention were retrieved from patients’ medical records and electronic database. HbA1c was collected at baseline, 4–6 months (post-1), and 8–12 months (post-2).ResultsWe included 956 patients, of which 60% were females with a median age of 58.0 (IQR: 5.0) years. Overall, the HbA1c reduced significantly from baseline (median: 10.2, IQR: 3.0) to post-1 (median: 8.8, IQR: 2.7) and post-2 (median: 8.3, IQR: 2.6%) (p < 0.001). There were 4317 pharmacists’ interventions performed, with the majority being dosage adjustment (n = 2407, 55.8%), followed by lab investigations (849, 19.7%), drugs addition (653, 15.1%), drugs discontinuation (408, 9.5%). Patients treated in hospitals received significantly more interventions than those treated in primary health clinics (p < 0.001). We observed significantly less reduction in HbA1c in DMTAC follow-up defaulters than non-defaulters after 1 year (− 1.02% vs. − 2.14%, p = 0.001). Frequencies of DMTAC visits (b: 0.19, CI: 0.079–0.302, p = 0.001), number of dosage adjustments (b: 0.83, CI: 0.015–0.151, p = 0.018) and number of additional drugs recommended (b: 0.37, CI: 0.049–0.691, p = 0.024) had positive impact on glycemic control whereas duration of diabetes (b: − 0.0302, CI: − 0.0507, − 0.007, p = 0.011) had negative impact.Conclusion Glycemic control improved significantly and sustained up to one year among patients in pharmacists-led DMTAC. However, DMTAC defaulters experienced poorer glycemic control. Considering more frequent visits and targeted interventions by pharmacists at DMTAC resulted in improved HbA1c control, these strategies should be taken into account for future program planning.

Real-world study of ethnic differences in glycaemic control and clinical characteristics among insulin-naïve people with type 2 diabetes initiating biphasic insulin aspart 30/70: A retrospective, observational cohort study in England.

This study investigated the ethnic differences in glycaemic levels and clinical characteristics among insulin-naïve people with type 2 diabetes (T2D) initiating biphasic insulin aspart 30/70 (BIAsp 30) in primary practice in England. Retrospective, observational cohort study utilizing data from the Clinical Practice Research Datalink Aurum database, including White, South Asian, Black and Chinese insulin-naïve adults with T2D, initiating BIAsp 30. The index date was that of the first BIAsp 30 prescription. Endpoints included change in glycated haemoglobin (HbA1c) and body mass index (BMI) 6 months post index. In total, 11 186 eligible people were selected (9443 White, 1116 South Asian, 594 Black, 33 Chinese). HbA1c decreased across all subgroups 6 months post index: estimated %-point changes [95% CI of -2.32 (-2.36; -2.28) (White); -1.91 (-2.02; -1.80) (South Asian); -2.55 (-2.69; -2.40) (Black); and -2.64 (-3.24; -2.04) (Chinese)]. The BMI increased modestly 6 months post index in all subgroups [estimated changes (95% CI) kg/m2 : White, 0.92 (0.86; 0.99); South Asian, 0.60 (0.41; 0.78); Black, 1.41 (1.16; 1.65); and Chinese, 0.32 (-0.67; 1.30)]. In the overall population, hypoglycaemic event rates increased from 0.92 events per 100 patient-years before the index to 3.37 events per 100 patient-years post index; event numbers were too low to be analysed by subgroup. Among insulin-naïve people with T2D initiating BIAsp 30, clinically meaningful HbA1c reductions in all ethnicities were observed. Some ethnic groups had larger reductions than others, but differences were small. In all groups, small BMI increases were seen, with small differences observed between groups. Hypoglycaemia rates were low.

Intensified follow-up of patients with type 1 diabetes and poor glycaemic control: a multicentre quality improvement collaborative based on data from the Norwegian Diabetes Register for Adults

BackgroundPatients with type 1 diabetes mellitus (T1DM) and poor glycaemic control are at high risk of developing microvascular and macrovascular complications. The aim of this study was to determine if...

Differences in positive expectancy of hybrid closed loop (HCL) insulin delivery systems do not explain racial differences in HCL use

AimsHybrid closed loop (HCL) insulin delivery systems improve glycemia and quality of life among youth with type 1 diabetes (T1D), however there are inequities in use. We aimed to evaluate whether differences in positive expectancy of HCL systems may explain differences in use. MethodsFifteen publicly-insured, non-Hispanic Black (NHB) youth with hemoglobin A1C (HbA1c) ≥ 10% enrolled in a study exploring changes in glycemia and person reported outcomes (PRO) during 6 months of Tandem t:slim X2 insulin pump with Control-IQ technology. At baseline youth and parents completed PROs, including Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations (INSPIRE) survey assessing positive expectancy of HCL use, and Problem Areas in Diabetes (PAID) survey assessing diabetes-related distress. Differences between this cohort and the Tandem Control-IQ pediatric pivotal trial (DCLP5) cohort were assessed. ResultsAs compared to the DCLP5 cohort (0% NHB, 10% publicly-insured), baseline glycemic indicators were suboptimal (MHbA1c 11.9 ± 1.4% vs 7.6 ± 0.9%, p < 0.0001; continuous glucose monitor (CGM) time-above-range > 180 mg/dL 82 ± 15% vs 45 ± 18%, p < 0.0001). INSPIRE scores in both cohorts were equally high among youth (80 ± 10 vs 77 ± 13, p = 0.41) and parents (88 ± 14 vs 85 ± 11, p = 0.37). PAID scores were higher among parents (68 ± 19 vs 43 ± 16, p < 0.0001), but not youth (43 ± 16 vs 35 ± 16, p = 0.09) in the historically marginalized cohort as compared to the DCLP5 cohort. ConclusionsDespite differences in glycemic control and diabetes related burden, positive expectancy of HCL systems is comparable among historically marginalized youth with T1D and the predominantly non-Hispanic White, privately insured DCLP5 cohort. These findings suggest that differences in perceptions of HCL technology may not explain inequities in use.

Real-time artificial intelligence assisted insulin dosage titration system for glucose control in type 2 diabetic patients: a proof of concept study

ObjectiveThis study aims to develop an insulin dosage adjustment model using machine learning of high quality electronic health records (EHRs) notes and then to form an artificial intelligence-based insulin clinical decision support workflow (iNCDSS) implemented in the HIS system to give a real-time recommendation of insulin dosage titration. The efficacy and safety in clinical practice is evaluated in this proof-of-concept study.Research design and methodsWe extracted patient-specific and time-varying features from the original EHRs data and performed machine learning analysis through 5-fold cross validation. In the patient-blind, single-arm interventional study, insulin dosage was titrated according to iNCDSS in type 2 diabetic inpatients for up to 7 d or until hospital discharge. The primary end point of the trial was the difference in glycemic control as measured by mean daily blood glucose concentration during the intervention period.ResultsA total of 3275 type 2 diabetic patients with 38,406 insulin counts were included for the model analysis. The XGBoost model presented the best performance with root mean square error (RMSE) of 1.06 unit and mean absolute relative difference (MARD) of 6.0% in the training dataset, and RMSE of 1.30 unit and MARD of 6.9% in the testing dataset. Twenty-three patients with T2DM (male 14, 60.9%; age 58.8 ± 10.7 years; duration of diabetes 11.8 ± 8.8 years, HbA1c 9.1 ± 1.1%) were enrolled in the proof of concept trial. The duration of iNCDSS intervention was 7.0 ± 0.1 d. The insulin dose recommended by iNCDSS was accepted by physicians in 97.8%. The mean daily capillary blood glucose was markedly improved during the intervention period, with a reduction of mean daily capillary BG from 11.3(8.0, 13.9) mmol/L in the first 24 h to 7.9(6.5,8.9) mmol/L in the last 24 h of the trial (P < 0.001). In addition, the time range below 3.9 mmol/L was decreased from 1.1% to 0.5%.ConclusionsThe clinical decision support system of insulin dosage titration developed using a machine learning algorithm based on the EHRs data was effective and safe in glycemic control in in type 2 diabetic inpatients.Trial registrationsClinicalTrials.gov Identifier: NCT04053959.

A randomized trial of oral gamma aminobutyric acid (GABA) or the combination of GABA with glutamic acid decarboxylase (GAD) on pancreatic islet endocrine function in children with newly diagnosed type 1 diabetes

Gamma aminobutyric acid(GABA) is synthesized by glutamate decarboxylase(GAD) in β-cells. Regarding Type 1 diabetes(T1D), animal/islet-cell studies found that GABA promotes insulin secretion, inhibits α-cell glucagon and dampens immune inflammation, while GAD immunization may also preserve β-cells. We evaluated the safety and efficacy of oral GABA alone, or combination GABA with GAD, on the preservation of residual insulin secretion in recent-onset T1D. Herein we report a single-center, double-blind, one-year, randomized trial in 97 children conducted March 2015 to June 2019(NCT02002130). Using a 2:1 treatment:placebo ratio, interventions included oral GABA twice-daily(n = 41), or oral GABA plus two-doses GAD-alum(n = 25), versus placebo(n = 31). The primary outcome, preservation of fasting/meal-stimulated c-peptide, was not attained. Of the secondary outcomes, the combination GABA/GAD reduced fasting and meal-stimulated serum glucagon, while the safety/tolerability of GABA was confirmed. There were no clinically significant differences in glycemic control or diabetes antibody titers. Given the low GABA dose for this pediatric trial, future investigations using higher-dose or long-acting GABA formulations, either alone or with GAD-alum, could be considered, although GABA alone or in combination with GAD-alum did nor preserve beta-cell function in this trial.

PSUN316 Racial Disparities in Diabetes Control and Use of Technology in a High Risk Cohort of Youth with Diabetes

Abstract Background Racial and ethnic minority children experience significant disparities in achieving the American Diabetes Association-recommended hemoglobin A1c (HbA1c) levels when compared to non-Hispanic Whites (NHW). Continuous glucose monitoring (CGM) and insulin pump (IP) use are associated with improved glycemic control. Racial and ethnic disparities exist in the use of these technologies in youth with Type 1 diabetes (T1D), which may contribute to the observed poor glycemic outcomes in this population. However, racial and ethnic differences in CGM and IP use have not been examined in children and adolescents with diabetes. Objective We describe the differences in glycemic control, CGM and IP use in an ethnically diverse cohort of children and adolescents seen in a multidisciplinary diabetes clinic designed to provide support (i.e., diabetes education, psychology, social work, nutrition) to youth with poorly controlled diabetes. Methods Demographic data, HbA1c levels, CGM and IP use were collected from a cohort of high-risk youth with T1D and T2D attending a multidisciplinary diabetes clinic from January to December of 2021. Results A total of 125 children and adolescents (age: 4-20 years) diagnosed with diabetes were included. Twenty (16%) were African Americans (AA), 81 (65%) Hispanic (H), 23 (15%) non-Hispanic White (NHW), and 1 (0.8%) Asian (A). The mean HbA1c in the cohort was 9.07%. HbA1c in AA patients was 12.9% (SD + 3.11), in Hispanics 8.64% (SD + 2.28), and 9.00% (SD + 1.84) in NHW. Seventy percent of AA patients had an A1c&amp;gt; 9%, compared to 36% of Hispanics and 48% of NHW. Use of CGM and IP was 40% and 10% in AA, 79% and 36% in Hispanics, and 82% and 57% in NHW, respectively. Conclusions Our study describes recent data on glycemic control and use of diabetes technology among a racially diverse cohort of children and adolescents seen in a multidisciplinary diabetes clinic. Consistent with literature on adults, HbA1c was highest and CGM and IP use were lowest in AA as compared to H and NHW youth. Data was collected during the COVID-19 pandemic, which may have disproportionately impacted AA patients’ economic, social, and personal behaviors that may contribute to diabetes care. These data support the need for multidisciplinary interventions using systems-based and culturally tailored approaches to improve access and use of technology for diabetes management. The current multidisciplinary diabetes clinic is designed to identify high-risk factors and reduce barriers to optimal management of diabetes. Future research will focus on the impact of multidisciplinary intervention on diabetes control through the use of technology, especially for African Americans. Presentation: Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m.