Greater Improvement In Glycemic Control Research Articles

A register-based study describing time trends in risk factor control and serious hypoglycaemia together with the effects of starting continuous glucose monitoring in people with type 1 diabetes in Norway.

To describe trends in risk factor control and serious hypoglycaemia in people with type 1 diabetes and to assess the effect of starting continuous glucose monitoring (CGM) in the real-world setting. Two cross-sectional surveys including 5746 individuals in 2012 and 18,984 individuals in 2020 based on data recorded in the Norwegian Diabetes Register for Adults (NDR-A) and an analysis of a longitudinal cohort of 2057 individuals where data on CGM and HbA1c were available in the NDR-A in 2012 and 2020. In the cross-sectional surveys mean HbA1c decreased from 66 mmol/mol (99% CI 65, 66) (8.2%) in 2012 to 61 mmol/mol (99% CI 61, 61) (7.7%) in 2020 (p < 0.0001). The proportion reporting serious hypoglycaemia decreased from 16.9 to 6.2% in 2020 (p < 0.0001). Mean LDL-cholesterol decreased from 2.80 (99% CI 2.78, 2.83) to 2.63 (99% CI 2.61, 2.65) mmol/l in 2020 (p < 0.0001). Mean blood pressure increased slightly. In the CGM cohort, we found a 3 mmol/mol (0.3%) greater improvement in mean HbA1c and a greater reduction in serious hypoglycaemia (-12.3% vs. -6.2%) among individuals that had started using CGM between 2013 and 2020 when compared with individuals that had not started using CGM. Between 2012 and 2020, we found marked improvements in glycaemic control and a considerable decrease in the proportion of individuals reporting serious hypoglycaemia. The proportion of individuals using CGM increased substantially and individuals that had started using CGM by 2020 showed greater improvement in glycaemic control and less serious hypoglycaemia.

Reduction of prevalence of patients meeting the criteria for metabolic syndrome with tirzepatide: a post hoc analysis from the SURPASS Clinical Trial Program

BackgroundMetabolic syndrome is characterized as the co-occurrence of interrelated cardiovascular risk factors, including insulin resistance, hyperinsulinemia, abdominal obesity, dyslipidemia and hypertension. Once weekly tirzepatide is approved in the US and EU for the treatment of type 2 diabetes (T2D) and obesity. In the SURPASS clinical trial program for T2D, tirzepatide demonstrated greater improvements in glycemic control, body weight reduction and other cardiometabolic risk factors versus placebo, subcutaneous semaglutide 1 mg, insulin degludec, and insulin glargine. This post hoc analysis assessed the effect of tirzepatide use on the prevalence of patients meeting the criteria for metabolic syndrome across SURPASS 1–5.MethodsMetabolic syndrome was defined as having ≥ 3 of 5 criteria according to the US National Cholesterol Education Program: Adult Treatment Panel III. Analyses were based on on-treatment data at the primary endpoint from patients adherent to treatment (taking ≥ 75% study drug). A logistic regression model with metabolic syndrome status as the response variable, metabolic syndrome status at the baseline visit as an adjustment, and randomized treatment as fixed explanatory effect was used. The effect of tirzepatide use on the prevalence of patients meeting the criteria for metabolic syndrome by categorical weight loss, background medication and gender were assessed.ResultsIn SURPASS, the prevalence of patients meeting the criteria for metabolic syndrome at baseline was 67–88% across treatment groups with reductions at the primary endpoint to 38–64% with tirzepatide versus 64–82% with comparators. Reductions in the prevalence of patients meeting the criteria for metabolic syndrome was significantly greater with all tirzepatide doses versus placebo, semaglutide 1 mg, insulin glargine, and insulin degludec (p < 0.001). Individual components of metabolic syndrome were also reduced to a greater extent with tirzepatide vs comparators. Greater reductions in body weight were associated with greater reductions in the prevalence of patients meeting the criteria for metabolic syndrome and its individual components. Background SGLT2i or sulfonylurea use or gender did not impact the change in prevalence of patients meeting the criteria for metabolic syndrome.ConclusionsIn this post hoc analysis, tirzepatide at all doses studied was associated with a greater reduction in the prevalence of patients meeting the criteria for metabolic syndrome compared to placebo, semaglutide 1 mg, insulin degludec, and insulin glargine. Although more evidence is needed, these data would support greater potential improvement in cardiovascular risk factor profile with tirzepatide treatment in people across the continuum of T2D.

SAT131 Acceptability And Impact Of Basic Carbohydrate Counting On Glycemic Control In Children And Young People With Type 1 Diabetes

Abstract Disclosure: A. Tandon: None. E. Bhowmik: None. Z. Ali: None. S. Tripathi: None. A. B k: None. V. Bhatia: None. P. Dabadghao: None. S. Sudhanshu: None. Background- Basic carbohydrate counting (BCC) represents a meal-planning approach for people with T1DM, emphasizing on consistency in the timing and amount of carbohydrate intake at each meal. In contrast to advanced carbohydrate counting, it is simpler to learn for people with varied levels of education or numeracy skills. The effect of BCC on glycemic control in children with T1DM using MDI is largely unknown. We aimed to determine whether BCC, compared to routine nutritional education (RNE) of our clinic, would improve glycemic control in these children with typical Indian diets. Methods- This randomized, controlled trial included children, adolescents and young adults with T1DM using MDI. In addition to RNE, the intervention group received BCC education including a personalised diet plan with suggestions for carbohydrate exchanges at each meal based on a 2-week food log prepared by them. The control group received the RNE of our clinic including instructions on healthy food choices, food groups, calorie-free foods, glycemic index, and instructions for special occasions. A retrospective CGM study and HbA1c were performed at baseline and at 12 weeks after the dietary education. The primary outcome was the difference in change in TIR (Time in range; 70-180 mg/dl) from baseline through 12 weeks between the two groups. A questionnaire on acceptability of BCC was administered. Results- Ninety two patients [age 15.7 ± 5.0 years, median (IQR) duration of diabetes 5.9 (5.9) years, baseline HbA1c 8.0 ± 1.5 %] wore the FreeStyle Libre Pro sensor for a median of 14 days. Median (IQR) TIR was 41 (18) %, TBR (Time below range; &amp;lt;70 mg/dl) 14 (13) % and TAR (Time above range; &amp;gt;180 mg/dl) 40.7 ± 20.4 %. Coefficient of variation (% CV) was 49.1±10.3% and 92% had high (&amp;gt;36 %) CV. Multivariate regression showed that older age at onset of diabetes was associated with a higher TIR, TBR and a lower TAR, whereas these glycemic metrics were not influenced by current age, urban vs rural residence, education of mother or socioeconomic status. The use of NPH vs glargine for basal insulin was also associated with higher TBR and %CV but lower TAR. Significant improvement was seen in HbA1c in the BCC group, when compared with their own values during the prior 24 months (baseline [8.2 ± 1.3%], 12 weeks [7.9 ± 1.2%], p = 0.042), but not so in the RNE group (baseline [8.0 ± 1.0%], 12 weeks [8.1 ± 1.0%], p = 0.881). However, no significant differences were observed in the changes in TIR, TBR, TAR, %CV and HbA1c between the two groups after 12 weeks of dietary intervention. Although, acceptability of BCC was high, only half of the participants correctly practiced it at more than 50 percent of their meals. Conclusion- Among our families with T1DM treated with MDI, although BCC had high acceptability, it was not frequently practiced and did not lead to greater improvement in glycemic control as compared to routine nutritional education. Presentation: Saturday, June 17, 2023

A multicomponent health care intervention is associated with improved glycaemic control in subjects with poorly controlled type 2 diabetes compared with routine care: The INTEGRA study.

The INTEGRA study evaluated whether a specially designed multicomponent health care intervention improved glycaemic control in subjects with poorly controlled type 2 diabetes compared with standard of care practice. Pragmatic study in subjects from primary care centres with type 2 diabetes and glycated haemoglobin (HbA1c) >9% (75 mmol/mol). The multifaceted intervention (N = 225 subjects) included a diabetes-focused visit encouraging therapeutic intensification by health care professionals. Retrospective data from matched controls (N = 675) were obtained from electronic medical records of a primary care database. The primary outcome was to compare the change in HbA1c values between the groups at 12 months of follow-up. The mean HbA1c decreased substantially in both groups after 3 months, and the mean reduction was significantly greater in the intervention group than in the usual care group after 12 months [mean difference -0.66% (-7 mmol/mol), 95% CI -0.4, -1.0; p < .001]. A larger percentage of participants in the intervention group achieved HbA1c <7% and <8% goals (15.5% vs. 5.3% and 29.3% vs. 13.5%, respectively; p < .001). The improvement in HbA1c levels was sustained throughout the study only in the intervention arm. Glucose-lowering therapy was more frequently intensified in patients in the intervention group at the initial and final time points of the study (between 0-3 and 6-12 months; p < .001), with a significant increase in the number of patients prescribed ≥2 antidiabetic therapies (p < .001). A multifaceted intervention oriented at reducing therapeutic inertia by primary care physicians was associated with greater improvement in glycaemic control compared with patients treated as per usual care.

115-OR: Improving Glycemic Outcomes through Virtual Diabetes Self-Management Education Pathway

The purpose of this quality improvement project was to implement and evaluate if a virtual diabetes self-management education (DSME) pathway is a cost-effective intervention in improving glycemic control for adult patients with type 2 diabetes (T2D). A one group pre and post-test design was utilized. Total of 41 participants completed the 4-week diabetes self-management pathway. The virtual curriculum integrated spaced education through a mobile health app called Calcium©. Primary outcome measure was change in HbA1c levels three months after intervention. Wilcoxon signed-rank test was used to analyze the difference before and after the DSME intervention. There was a 1.6% mean reduction of HbA1c levels (P=&amp;lt;0.001). There was also statistically significant improvement of other metabolic markers including blood sugar averages, body weight, BMI and systolic blood pressure (P=&amp;lt;0.005). Mean comparison of HbA1c shows that those who significantly utilized the virtual pathway were found to have greater improvement in glycemic control (-2.55% vs -0.43%). This quality improvement project implemented evidence-based interventions to improve patient outcomes, lower healthcare cost and hopefully influence health care policy. Moving this body of knowledge forward with attention to developing and implementing DSME initiatives and exploring novel practice models open doors for building this body of evidence further. Disclosure E.P.Soliman: None.

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...

Changes in Glycemic Control Following Use of a Spanish-Language, Culturally Adapted Diabetes Program: Retrospective Study

Several barriers to diabetes treatment and care exist, particularly in underserved medical communities. This study aimed to evaluate a novel, culturally adapted, Spanish-language mHealth diabetes program for glycemic control. Professional Spanish translators, linguists, and providers localized the entirety of the Vida Health Diabetes Management Program into a culturally relevant Spanish-language version. The Spanish-language Vida Health Diabetes Management Program was used by 182 (n=119 women) Spanish-speaking adults with diabetes. This app-based program provided access to culturally adapted educational content on diabetes self-management, one-on-one remote counseling and coaching sessions, and on-demand in-app messaging with bilingual (Spanish and English) certified health coaches, registered dietitian nutritionists, and certified diabetes care and education specialists. Hemoglobin A1c (HbA1c) was the primary outcome measure, and a 2-tailed, paired t test was used to evaluate changes in HbA1c before and after program use. To determine the relationship between program engagement and changes in glycemic control, a cluster-robust multiple regression analysis was employed. We observed a significant decrease in HbA1c of -1.23 points between baseline (mean 9.65%, SD 1.56%) and follow-up (mean 8.42%, SD 1.44%; P<.001). Additionally, we observed a greater decrease in HbA1c among participants with high program engagement (high engagement: -1.59%, SD 1.97%; low engagement: -0.84%, SD 1.64%; P<.001). This work highlights improvements in glycemic control that were clinically as well as statistically significant among Spanish-preferring adults enrolled in the Vida Health Spanish Diabetes Management Program. Greater improvements in glycemic control were observed among participants with higher program engagement. These results provide needed support for the use of digital health interventions to promote meaningful improvements in glycemic control in a medically underserved community.

Effectiveness of roux-en-Y gastric bypass vs sleeve gastrectomy on lipid levels in type 2 diabetes: a meta-analysis

Abstract Introduction Obesity and its co-morbidities, including type 2 diabetes (T2DM) and dyslipidemia, are accompanied by excess cardiovascular morbi-mortality. Aside from excess low density lipoprotein-cholesterol (LDL-C), atherogenic dyslipidemia (AD), mainly characterized by elevated triglycerides and decreased high density lipoprotein-cholesterol (HDL-C) levels, is often present in T2DM obese patients. Bariatric surgery, such as Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG), has become a reference treatment in that population. However, the respective effects of RYGB vs SG on lipid metabolism in T2DM patients have been rarely studied. Methods A meta-analysis of randomized controlled trials, comparing the effects of RGYBG vs SG on lipid metabolism 12 months after surgery in T2DM patients, was performed. Results Four studies including a total of 298 patients (151 patients in the RYGB and 147 patients in the SG group) were examined. Despite a greater decrease in body mass index and greater improvement in glycaemic control in RYGB compared to SG. RYGB vs SG was more effective in reducing total cholesterol, LDL-C and non-HDL-C levels (mean difference [MD] −24.10 mg/dL, 95% CI −33.76 to −14.44, p&amp;lt;0.00001; [MD] −23.24 mg/dL, 95% CI −34.84 to −11.63, p&amp;lt;0.00001 and MD 31.70 mg/dL, 95% CI −46.00 to −17.40, p&amp;lt;0.00001, respectively). Conclusions The superiority of RYGB vs SG in reducing LDL-C, with an effect comparable to a moderate-intensity statin, suggests RYBG should be favoured in hypercholesterolemic T2DM patients in order to further reduce cardiovascular risk. Funding Acknowledgement Type of funding sources: None.

967-P: Decentralizing Diabetes Specialty Care Improves Glycemic Control

Parkland Health and Hospital System (PHHS) is the Dallas County safety-net health system and serves indigent Dallas County residents. PHHS has primary care clinics (COPCs) located in underserved areas of the county to provide easier access to its residents. The Diabetes Specialty Clinic (DSC) is located next to the Parkland Hospital, but this location can be difficult to access for patients with limited means. We studied the effect of co-locating a diabetes specialty practice (H-DSC) at a community primary care practice (Hatcher Station COPC (HSC)) by comparing the A1c change between the patients managed by primary care providers at HSC alone or by specialists at H-DSC. Table 1 displays the results of this study. The data show that there was a significant reduction in A1c in the HSC patients seen by primary care and H-DSC patients of -0.2% and -0.5% respectively. There is also a significant difference in baseline and final A1cs between both groups that show that H-DSC patients had poorer baseline glycemic control but also greater improvement in glycemic control. H-DSC patients were also being seen by their primary care providers at HSC, and without the co-location of the DSC to H-DSC, many of these patients would not have accessed care at the DSC main location. This suggests that co-locating diabetes specialty services at local, easy-to-access primary care centers at a safety-net health system can improve the glycemic control of patients with diabetes. Disclosure U.Gunasekaran: None.

Effectiveness of Roux-en-Y Gastric Bypass vs Sleeve Gastrectomy on Lipid Levels in Type 2 Diabetes: a Meta-analysis

IntroductionObesity and its co-morbidities, including type 2 diabetes (T2DM) and dyslipidemia, are accompanied by excess cardiovascular morbi-mortality. Aside from excess low density lipoprotein-cholesterol (LDL-C), atherogenic dyslipidemia (AD), mainly characterized by elevated triglycerides and decreased high density lipoprotein-cholesterol (HDL-C) levels, is often present in T2DM obese patients. Bariatric surgery, such as Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG), has become a reference treatment in that population. However, the respective effects of RYGB vs SG on lipid metabolism in T2DM patients have been rarely studied. MethodsA meta-analysis of randomized controlled trials, comparing the effects of RGYBG vs SG on lipid metabolism 12 months after surgery in T2DM patients, was performed. ResultsFour studies including a total of 298 patients (151 patients in the RYGB and 147 patients in the SG group) were examined. Despite a greater decrease in body mass index and greater improvement in glycemic control in RYGB compared to SG. RYGB vs SG was more effective in reducing total cholesterol, LDL-C, and non-HDL-C levels (mean difference [MD] −26.10 mg/dL, 95 % CI −38.88 to −13.50, p<0.00001; [MD] −20.10 mg/dL, 95 % CI −27.90 to −12.20, p<0.00001 and MD 31.90 mg/dl, 95 % CI −46.90 to −16.80, p<0.00001, respectively). ConclusionsThe superiority of RYGB vs SG in reducing LDL-C, with an effect comparable to a moderate-intensity statin, suggests RYBG should be favored in hypercholesterolemic T2DM patients in order to further reduce cardiovascular risk.

Effect of Treatment of OSA With CPAP on Glycemic Control in Adults With Type 2 Diabetes: The Diabetes Sleep Treatment Trial (DSTT)

ObjectiveThe effect of obstructive sleep apnea (OSA) treatment with continuous positive airway pressure (CPAP) on glycemic measures in patients with type 2 diabetes (T2D) remains unclear. We aimed to determine whether CPAP treatment of OSA improves glycemic measures in patients with T2D. MethodsThis randomized controlled trial (N = 98) examined changes in glycemic measures following 12 weeks of active (n = 49) or sham (n = 49) CPAP and consideried participants’ adherence to CPAP therapy (percentage of days with ≥4 hours use and average hours/day of use). ResultsBaseline treatment groups were similar. Regarding the efficacy of active vs sham-CPAP over time, at 6 weeks, both groups had similar reductions in fructosamine (mean difference [MD], 95% confidence interval [CI]: CPAP −13.10 [−25.49 to −0.7] vs. sham −7.26 [−20.2 to 5.69]; P = .519) but different in HbA1c (CPAP −0.24 [−0.48 to −0.003] vs sham 0.15 [−0.10 to 0.4]; P = .027). At 12 weeks, reductions in HbA1c values were similar by group (CPAP −0.26 [−0.53 to 0.002] vs sham −0.24 [−0.53 to 0.04]; P = .924). HbA1c reductions were associated with a greater percentage of cumulative days of CPAP usage ≥4 hours per day (b [SE] = 0.006 [0.002]; P = .013) and cumulative hours of CPAP use (b [SE] = 0.08 [0.08]; P = .012). CPAP use of ≥7 hours was associated with a significant reduction in HbA1c (b [SE] 0.54 [0.16]; P = .0012). ConclusionCPAP treatment of OSA did not result in sustained improved glycemic control compared to sham in the intent-to-treat analysis. CPAP adherence was associated with greater improvements in glycemic control.

Effectiveness of Mobile Phone and Web-Based Interventions for Diabetes and Obesity Among African American and Hispanic Adults in the United States: Systematic Review.

BackgroundMobile health (mHealth) and web-based technological advances allow for new approaches to deliver behavioral interventions for chronic diseases such as obesity and diabetes. African American and Hispanic adults experience a disproportionate burden of major chronic diseases.ObjectiveThis paper reviews the evidence for mHealth and web-based interventions for diabetes and obesity in African American and Hispanic adults.MethodsLiterature searches of PubMed/Medline, The Cochrane Library, EMBASE, CINAHL Plus, Global Health, Scopus, and Library & Information Science Source were conducted for relevant English-language articles. Articles identified through searches were reviewed by 2 investigators and, if they met the inclusion criteria, were extracted and assessed for risk of bias. Findings were summarized in tabular and narrative format. The overall strength of the evidence was assessed as high, moderate, low, or insufficient on the basis of risk of bias, consistency of findings, directness, precision, and other limitations.ResultsSearches yielded 2358 electronic publications, 196 reports were found to be eligible for inclusion, and 7 studies met the eligibility criteria. All 7 included studies were randomized control trials. Five studies evaluated the effectiveness of an mHealth intervention for weight loss, including one that evaluated the effectiveness for diabetes and two studies focused on diabetes. Of all the studies that focused on weight loss, 3 reported significant differences in weight loss in participants in the intervention group compared with those in the usual care group. Although all studies on diabetes control showed greater improvement in glycemic control for the intervention group compared to that in the control group, only one study showed a significant difference between the 2 groups.ConclusionsThis analysis indicates that there are few published studies that assessed mHealth interventions among minority populations and focused on weight or diabetes. Although the overall strength of evidence was low for diabetes control, it was moderate for weight loss, and our findings suggest that mHealth and web-based interventions may provide a promising approach for interventions among African American and Hispanic adults who have obesity or diabetes.

Comparative Effects of Metformin and Dipeptidyl Peptidase-4 Inhibitors in Japanese Obese Patients with Type 2 Diabetes: A Claims Database Study.

IntroductionMetformin has demonstrated favorable effects on glycemic control in patients with type 2 diabetes (T2D), regardless of the body mass index (BMI). On the contrary, dipeptidyl peptidase-4 inhibitors (DPP-4is) are reportedly less effective in patients having high BMI values (≥ 25 or ≥ 30). The aim of this study was to compare metformin and DPP-4is as first-line treatment for their effects on glycemic control and improvement of other health outcomes among obese and non-obese Japanese patients with T2D.MethodsA Japanese health insurance claims database that also included annual medical checkup data was used. This database included data on company employees who were members of health insurance societies and their family members. Most patients were aged < 65 years and most were men. Inclusion criteria were: (1) a first T2D diagnosis between May 2010 and June 2017; (2) either metformin or a DPP-4i prescribed as the first-line antidiabetic therapy; and (3) glycated hemoglobin (HbA1c) and BMI data available for the 3-month period immediately preceding the initiation of antidiabetic treatment (baseline). The reduction rate in excessive HbA1c (> 6.5%; primary outcome) and changes in fasting plasma glucose, BMI, triglyceride, cholesterol, and abdominal circumference (secondary outcomes) at 12 months from baseline were compared between treatments.ResultsWhen evaluated relative to the baseline BMI, the mean reduction rate in excessive HbA1c tended to be higher in the metformin group than in the DPP-4i group, especially in patients with BMI ≥ 25. Similarly, significant improvement was observed in most outcomes in obese patients prescribed metformin compared to those prescribed a DPP-4i. In contrast, in patients with BMI < 25, HbA1c reduction was greater in patients prescribed DPP-4i and fewer outcomes showed significant improvement in patients prescribed metformin.ConclusionIn obese Japanese patients with T2D, greater improvements in glycemic control and other outcomes were seen with metformin as first-line treatment for T2D compared with DPP-4is, although some limitations regarding the database information should be considered.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-021-01101-2.

The effects of cognitive behavioral therapy for insomnia in people with type 2 diabetes mellitus, pilot RCT part II: diabetes health outcomes

BackgroundPrevious studies have shown the negative impact of sleep disturbances, specifically insomnia symptoms, on glucose metabolism for people with type 2 diabetes (T2D). People with insomnia symptoms are at risk of poor glycemic control and suboptimal diabetes self-care behavior (DSCB). Investigating the impact of a safe and effective intervention for individuals with T2D and insomnia symptoms on diabetes’ health outcomes is needed. Therefore, the aim of this exploratory study is to examine the effects of Cognitive Behavioral Therapy for Insomnia (CBT-I) on glycemic control, DSCB, and fatigue.MethodsTwenty-eight participants with T2D and insomnia symptoms, after passing an eligibility criteria at a medical research center, were randomly assigned to CBT-I (n = 14) or Health Education (HE; n = 14). The CBT-I and HE groups received 6 weekly one-hour sessions. This Randomized Controlled Trial (RCT) used a non-inferiority framework to test the effectiveness of CBT-I. Validated assessments were administered at baseline and post-intervention to assess glycemic control, DSCB, and fatigue. A Wilcoxon signed-rank test was utilized to compare within-group changes from baseline to post-intervention. A Mann-Whitney test was utilized to measure the between-group differences. Linear regression was used to assess the association between the blood glucose level and the number of days in the CBT-I group.ResultsThe recruitment duration was from October 2018 to May 2019. A total of 13 participants completed the interventions in each group and are included in the final analysis. No adverse events, because of being a part of this RCT, were reported. CBT-I participants showed significantly greater improvement in glycemic control, DSCB, and fatigue. There was a significant association between the number of days in the CBT-I intervention with the blood glucose level before bedtime (B = -0.56, p = .009) and after awakening in the morning (B = -0.57, p = .007).ConclusionsThis study demonstrated a clinically meaningful effect of CBT-I on glycemic control in people with T2D and insomnia symptoms. Also, CBT-I positively impacted daytime functioning, including DSCB and fatigue. Future research is needed to investigate the long-term effects of CBT-I on laboratory tests of glycemic control and to understand the underlying mechanisms of any improvements.Trial registrationClinical Trials Registry (NCT03713996). Retrospectively registered on 22 October 2018,

Real-world evidence of the effectiveness on glycaemic control of early simultaneous versus later sequential initiation of basal insulin and glucagon-like peptide-1 receptor agonists.

AimTo assess the impact of the timing of initiating both basal insulin and glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) on reaching glycaemic control targets over 6 and 12 months in people with type 2 diabetes (T2D) uncontrolled on oral antihyperglycaemic drugs with an HbA1c of 9% or higher.MethodsThis retrospective cohort study assessed the impact of the timing of initiating both basal insulin and GLP‐1 RA therapies on reaching glycaemic targets (HbA1c < 7% and <8%, and ≥1% and ≥2% HbA1c reduction) over 12 months in people with markedly uncontrolled T2D (HbA1c ≥ 9%) on oral antihyperglycaemic drugs identified on the Optum Humedica database (electronic medical records; 1 January 2011 to 30 June 2017). Study cohorts were defined by the days between initiating each injectable: cohort A, 30 days or less (simultaneous initiation) and cohorts B, 31‐90, C, 91‐180, D, 181‐270 and E, 271‐360 days (sequential initiation).ResultsCohort A had the best glycaemic outcomes at 6 and 12 months for all four endpoints, followed by cohort B. The likelihood of achieving an HbA1c of less than 7% did not significantly differ between cohorts A and B (hazard ratio [95% confidence interval]: 0.87 [0.76‐1.01]); cohorts C, D and E were significantly less likely to achieve an HbA1c of less than 7% than cohort A (0.62 [0.53‐0.72]; 0.62 [0.53‐0.72]; 0.63 [0.54‐0.73]).ConclusionsIn people with uncontrolled T2D requiring treatment with a GLP‐1 RA and basal insulin, greater improvements in glycaemic control were observed when both therapies were initiated within close proximity of one another (≤90 days) compared with initiation 91‐360 days apart.

Effect of 6 Months of Flash Glucose Monitoring in Youth With Type 1 Diabetes and High-Risk Glycemic Control: A Randomized Controlled Trial.

To investigate whether intermittently scanned continuous glucose monitoring (isCGM) significantly improves glycemic control compared with capillary self-monitored blood glucose (SMBG) in youth with type 1 diabetes and high-risk glycemic control. This multicenter 6-month randomized, controlled, parallel-arm trial included 64 participants aged 13-20 years with established type 1 diabetes and glycated hemoglobin (HbA1c) ≥9% (≥75 mmol/mol). Participants were allocated to 6-month intervention (isCGM; FreeStyle Libre; Abbott Diabetes Care, Witney, U.K.) (n = 33) or control (SMBG; n = 31) using minimization. The primary outcome was the difference in change in HbA1c from baseline to 6 months. There was no evidence of a difference between groups for changes in HbA1c at 6 months (adjusted mean 0.2% greater improvement for isCGM [95% CI -0.9 to 0.5] [-2.1 mmol/mol (95% CI -9.6 to 5.4)]; P = 0.576). However, glucose-monitoring frequency was 2.83 (95% CI 1.72-4.65; P < 0.001) times higher in the isCGM group compared with that in the SMBG group at 6 months. The change in the Diabetes Treatment Satisfaction Questionnaire mean item score also favored isCGM at 6 months (P = 0.048), with no significant differences between groups for fear of hypoglycemia and quality of life (both general and diabetes specific) (all P > 0.1). For youth with high-risk glycemic control, isCGM led to improvements in glucose testing frequency and diabetes treatment satisfaction. However, these did not translate to greater improvement in glycemic control over usual care with SMBG at 6 months.

871-P: Baseline Time-in-Range Association with Glycemic Improvement in Adults with Type 1 Diabetes (T1D)

The DIAMOND study demonstrated real-time continuous glucose monitors (CGM) improve glycemic control for adults with T1D using multiple daily injections; subsequent analysis showed greatest benefit in participants with higher baseline A1C. This analysis assesses the relationship between baseline time in range (TIR) and change in TIR during the study with CGM or self-monitoring of blood glucose (SMBG). Baseline TIR was divided into three categories: &amp;lt;40% (9.6 h/d), &amp;lt;50% (12 h/d), and &amp;lt;60% (14.4 h/d). Of 153 participants, mean A1C was 8.6±0.6% and the mean TIR was 46±12% (10.9±2.9 h/d) at baseline. Mean increase in TIR was greater among CGM users versus SMBG users for all three baseline TIR categories (18 min/d for baseline TIR &amp;lt;40%, 90 min/d for baseline TIR &amp;lt;50%, 88 min/d for baseline TIR &amp;lt;60%). A greater percentage of participants using CGM had &amp;gt;4 h/d increase in TIR across all baseline TIR groups, and &amp;gt;2 h/d increase in TIR in most baseline TIR groups, although a few were not significant due to small sample size (Figure). The most noticeable difference occurred for participants with a baseline TIR &amp;lt;50%, with 29% of CGM users increasing TIR by &amp;gt;4 h/d compared with no SMBG users (P=0.004). Similar trends were found for improvement in mean glucose and time spent in hyper- and hypoglycemic ranges. Overall, results suggest greater improvement in glycemic control for CGM users than for SMBG users across all baseline TIR groups. Disclosure P. Calhoun: Stock/Shareholder; Self; Dexcom, Inc. D.A. Price: Employee; Self; Dexcom, Inc. R. Beck: None. Funding Dexcom, Inc.

Dietary fibre and whole grains in diabetes management: Systematic review and meta-analyses

Fibre is promoted as part of a healthy dietary pattern and in diabetes management. We have considered the role of high-fibre diets on mortality and increasing fibre intake on glycaemic control and other cardiometabolic risk factors of adults with prediabetes or diabetes. We conducted a systematic review of published literature to identify prospective studies or controlled trials that have examined the effects of a higher fibre intake without additional dietary or other lifestyle modification in adults with prediabetes, gestational diabetes, type 1 diabetes, and type 2 diabetes. Meta-analyses were undertaken to determine the effects of higher fibre intake on all-cause and cardiovascular mortality and increasing fibre intake on glycaemic control and a range of cardiometabolic risk factors. For trials, meta regression analyses identified further variables that influenced the pooled findings. Dose response testing was undertaken; Grading of Recommendations Assessment, Development and Evaluation (GRADE) protocols were followed to assess the quality of evidence. Two multicountry cohorts of 8,300 adults with type 1 or type 2 diabetes followed on average for 8.8 years and 42 trials including 1,789 adults with prediabetes, type 1, or type 2 diabetes were identified. Prospective cohort data indicate an absolute reduction of 14 fewer deaths (95% confidence interval (CI) 4-19) per 1,000 participants over the study duration, when comparing a daily dietary fibre intake of 35 g with the average intake of 19 g, with a clear dose response relationship apparent. Increased fibre intakes reduced glycated haemoglobin (HbA1c; mean difference [MD] -2.00 mmol/mol, 95% CI -3.30 to -0.71 from 33 trials), fasting plasma glucose (MD -0.56 mmol/L, 95% CI -0.73 to -0.38 from 34 trials), insulin (standardised mean difference [SMD] -2.03, 95% CI -2.92 to -1.13 from 19 trials), homeostatic model assessment of insulin resistance (HOMA IR; MD -1.24 mg/dL, 95% CI -1.72 to -0.76 from 9 trials), total cholesterol (MD -0.34 mmol/L, 95% CI -0.46 to -0.22 from 27 trials), low-density lipoprotein (LDL) cholesterol (MD -0.17 mmol/L, 95% CI -0.27 to -0.08 from 21 trials), triglycerides (MD -0.16 mmol/L, 95% CI -0.23 to -0.09 from 28 trials), body weight (MD -0.56 kg, 95% CI -0.98 to -0.13 from 18 trials), Body Mass Index (BMI; MD -0.36, 95% CI -0·55 to -0·16 from 14 trials), and C-reactive protein (SMD -2.80, 95% CI -4.52 to -1.09 from 7 trials) when compared with lower fibre diets. All trial analyses were subject to high heterogeneity. Key variables beyond increasing fibre intake were the fibre intake at baseline, the global region where the trials were conducted, and participant inclusion criteria other than diabetes type. Potential limitations were the lack of prospective cohort data in non-European countries and the lack of long-term (12 months or greater) controlled trials of increasing fibre intakes in adults with diabetes. Higher-fibre diets are an important component of diabetes management, resulting in improvements in measures of glycaemic control, blood lipids, body weight, and inflammation, as well as a reduction in premature mortality. These benefits were not confined to any fibre type or to any type of diabetes and were apparent across the range of intakes, although greater improvements in glycaemic control were observed for those moving from low to moderate or high intakes. Based on these findings, increasing daily fibre intake by 15 g or to 35 g might be a reasonable target that would be expected to reduce risk of premature mortality in adults with diabetes.

1149-P: A1C Goal Attainment after Metformin (MET) Uptitration With and Without Sitagliptin (SITA): Impact of Baseline and Target A1C

MET is generally recommended as the initial AHA for T2D, but many patients do not achieve glycemic goal at an initial, sub-maximal dose (500-1000 mg/day) and should intensify therapy. Typically, MET dose is first maximized, followed by addition of a second AHA as needed. This sequential approach can result in prolonged exposure to hyperglycemia. Therefore, addition of a second AHA during MET up-titration may be appropriate for some patients. In a recent study, patients with T2D not at glycemic goal on 1000 mg/day MET initiated SITA or PBO while increasing MET dose to 2000 mg/day. Study participants had entry A1C ≥7.5% (mean = 8.6%) and baseline characteristics were balanced. SITA provided greater improvement in glycemic control and likelihood of A1C goal attainment, with similar safety and tolerability compared to PBO. In a post hoc analysis characterizing the impact of baseline A1C, A1C goal, and treatment on A1C goal attainment, the likelihood of A1C goal attainment decreased as distance to goal at baseline increased (Table). Compared to MET increase alone, MET increase + SITA was generally more effective in achieving glycemic targets across a range of goals and baseline A1C. These results suggest that the distance to A1C goal should be considered throughout the process of MET up-titration to inform AHA intensification strategy, including the potential benefit of early SITA initiation. Disclosure M. Crutchlow: Consultant; Spouse/Partner; Crinetics, Novartis Pharmaceuticals Corporation, ProSciento, Soleno Therapeutics, Zealand Pharma A/S. Employee; Self; Merck &amp; Co., Inc. Research Support; Spouse/Partner; Dexcom, Inc. J. Lin: Employee; Self; Merck &amp; Co., Inc. Stock/Shareholder; Self; Merck &amp; Co., Inc. R.L. Lam: Employee; Self; Merck &amp; Co., Inc. E.A. O'Neill: Employee; Self; Merck &amp; Co., Inc. Stock/Shareholder; Self; Merck &amp; Co., Inc. K.D. Kaufman: Employee; Self; Merck &amp; Co., Inc. Stock/Shareholder; Self; Merck &amp; Co., Inc. S.S. Engel: Employee; Self; Merck &amp; Co., Inc. Stock/Shareholder; Self; Merck &amp; Co., Inc. Funding Merck &amp; Co., Inc.

Glycemic Outcomes with Early Initiation of Continuous Glucose Monitoring System in Recently Diagnosed Patients with Type 1 Diabetes.

We investigated the efficacy and safety of continuous glucose monitoring (CGM) initiation within 1 year of type 1 diabetes (T1D) diagnosis among children, adolescents, and adults. Differences in mean A1c (primary outcome) and diabetes-related emergency visits (secondary outcome) for 2.5 years between early CGM users and non-CGM users were studied among 396 newly diagnosed patients with T1D (94% children [age <18 years], 5% adults, 46% females) between January 2013 and December 2015 at Barbara Davis Center for Diabetes. The primary outcome was adjusted by age at diagnosis and gender. P < 0.05 was considered significant. Gender, ethnicity, body mass index, and A1c at diagnosis were similar between the groups. Irrespective of insulin delivery methods, CGM users had a significantly greater improvement in glycemic control than non-CGM users at 1, 1.5, 2, and 2.5 years. For 2.5 years of follow-up, the multiple daily injection (MDI)+CGM group (n = 19) had 1.5% ± 0.2% lower A1c than the MDI only group (n = 225) (7.7% ± 0.2% vs. 9.2% ± 0.04%, P < 0.0001), and the insulin pump (continuous subcutaneous insulin infusion [CSII])+CGM group (n = 62) had 0.7% ± 0.1% lower A1c than the CSII only group (n = 90) (8.0% ± 0.08% vs. 8.7% ± 0.07%, P < 0.0001). The MDI+CGM group had significantly lower A1c than the CSII only group (7.7% ± 0.2% vs. 8.7% ± 0.07%, P < 0.0001). The number of diabetes-related (severe hypoglycemia or hyperglycemia) emergency department visits was significantly lower among early CGM users compared with non-CGM users (P = 0.003). Irrespective of insulin delivery system, early initiation of CGM within 1 year from T1D diagnosis was associated with better glucose control and fewer diabetes-related emergency visits.