Sustained Improvement In Glycemic Control Research Articles

Eighteen-Month Hybrid Closed-Loop Use in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Trial.

We aimed to evaluate the longer-term safety and efficacy of hybrid closed-loop (CL) therapy in very young children with type 1 diabetes (T1D). Following a 16-week multinational, randomized crossover trial comparing hybrid CL with sensor-augmented pump (SAP) therapy in 74 very young children aged 1-7 years with T1D, participants were invited to an extension phase using CL for a further 18 months. Outcomes were compared with the primary-phase SAP period and primary-phase CL period. After the primary study phase, 60 participants were eligible to enroll in the extension. Of these, 49 consented (mean ± SD age 6.6 ± 1.5 years) to continue use of CL for 18 months. Percentage time in range (TIR) 3.9-10.0 mmol/L was 8.4 percentage points (95% CI 6.7 to 10.1; P < 0.001) higher, while HbA1c was 0.4% ([5.0 mmol/mol], 95% CI 0.3 to 0.6 [3.7 to 6.2]; P < 0.001) lower during the CL extension phase compared with primary-phase SAP period. At 18 months, mean HbA1c was 6.7 ± 0.5% and TIR was 70 ± 7%, compared with 6.7 ± 0.5% and 71 ± 6% in the primary-phase CL period. Time in hypoglycemia (<3.9 mmol/L) was similar between CL extension phase and both primary-phase SAP (P = 0.31) and CL periods (P = 0.70). There were two severe hypoglycemia events and one other serious adverse event during the extension phase. One unexpected serious adverse device effect occurred. Use of the Cambridge hybrid CL system led to sustained improvements in glycemic control lasting more than 18 months in very young children with T1D.

Real-Life Use of Automated Insulin Delivery in Individuals With Type 2 Diabetes.

The objective of this work is to document performance of automated insulin delivery (AID) during real-life use in type 2 diabetes (T2D). A retrospective analysis was performed of continuous glucose monitoring and insulin delivery data from 796 individuals with T2D, who transitioned from 1-month predictive low-glucose suspend (PLGS) use to 3-month AID use, in real-life settings. Primary outcome was change of time in range (TIR = 70-180 mg/dL) from PLGS to AID. Secondary outcomes included time above/below range (TAR/TBR) and total daily insulin (TDI). Compared with PLGS, AID increased TIR on average from 63.2% to 72.6%, decreased TAR from 36.2% to 26.8%, and increased TDI from 70.2 to 76.3 U (all P < .001), without significant change to TBR. Glycemic improvements were more pronounced in those with worse glycemic control during PLGS use (P < .001). Real-life use of AID led to a rapid and sustained improvement of glycemic control in individuals with T2D.

Single anastomosis duodeno-ileal bypass with sleeve gastrectomy generates sustained improvement of glycemic control compared with sleeve gastrectomy in the diet-induced obese rat model.

Bariatric surgery has become a recognized and effective procedure for treating obesity and type 2 diabetes (T2D). Our objective was to directly compare the caloric intake-independent effects of sleeve gastrectomy (SG) and single anastomosis duodenoileal bypass with SG (SADI-S) on glucose tolerance in rats with diet-induced obesity (DIO) and to elucidate the differences between bariatric surgery and caloric restriction.A total of 120 adult male Wistar rats with DIO and insulin resistance were randomly assigned to surgical (sham operation, SG, and SADI-S) and dietary (pair-feeding the amount of food eaten by animals undergoing the SG or SADI-S surgeries) interventions. Body weight and food intake were weekly monitored, and 6weeks after interventions, fasting plasma glucose, oral glucose and insulin tolerance tests, plasma insulin, adiponectin, GIP, GLP-1, and ghrelin levels were determined.The body weight of SADI-S rats was significantly (p < 0.001) lower as compared to the sham-operated, SG, and pair-fed groups. Furthermore, SADI-S rats exhibited decreased whole body fat mass (p < 0.001), lower food efficiency rates (p < 0.001), and increased insulin sensitivity, as well as improved glucose and lipid metabolism compared to that of the SG and pair-fed rats.SADI-S was more effective than SG, or caloric restriction, in improving glycemic control and metabolic profile, with a higher remission of insulin resistance as well as long-term weight loss.

Continuous Subcutaneous Insulin Infusions: Closing the Loop.

Continuous subcutaneous insulin infusions (CSIIs) and continuous glucose monitors (CGMs) have revolutionized the management of diabetes mellitus (DM). Over the last 2 decades the development of advanced, small, and user-friendly technology has progressed substantially, essentially closing the loop in the fasting and postabsorptive state, nearing the promise of an artificial pancreas (AP). The momentum was mostly driven by the diabetes community itself, to improve its health and quality of life. Literature regarding CSII and CGM was reviewed. Management of DM aims to regulate blood glucose to prevent long-term microvascular and macrovascular complications. CSIIs combined with CGMs provide an integrated system to maintain tight glycemic control in a safe and uninterrupted fashion, while minimizing hypoglycemic events. Recent advances have allowed to "closing of the loop" by better mimicking endogenous insulin secretion and glucose level regulation. Evidence supports sustained improvement in glycemic control with reduced episodes of hypoglycemia using these systems, while improving quality of life. Ongoing work in delivery algorithms with or without counterregulatory hormones will allow for further layers of regulation of the AP. Ongoing efforts to develop an AP have created effective tools to improve the management of DM. CSIIs and CGMs are useful in diverse populations ranging from children to older individuals, as well as in various clinical contexts. Individually and more so together, these have had a tremendous effect on the management of DM, while avoiding treatment fatigue. However, cost and accessibility are still a hindrance to its wider application.

Sustained Improvement in Glycemic Control in Emerging Adults with Type1 Diabetes 2Years After the Start of the COVID-19 Pandemic.

Although there were initial concerns that the public health response to the COVID-19 pandemic would adversely affect glycemic control in people with type1 diabetes, several early continuous glucose monitor (CGM) studies reported an unexpected slight improvement in glucose metrics. Early emerging adulthood (roughly spanning the ages of 18-24years) is often a vulnerable time in the life of a person with type1 diabetes. Here, we set out to determine how the care and glucose management of emerging adults with type1 diabetes changed over a period of approximately 2years from the start of the COVID-19 pandemic. This was a retrospective study of a tertiary referral, multidisciplinary young adult diabetes clinic, spanning before and after the 777-day state of emergency in the City of Toronto. Of 130 emerging adults with type1 diabetes (80 male, 50 female; mean age 21.0 ± 2.1years), baseline pre-pandemic HbA1c values were available for 120 individuals. During 24.9 ± 5.4months of follow-up before and after the start of the COVID-19 pandemic, HbA1c fell from 8.5 ± 1.7% (69.3 ± 18.8mmol/mol) to 8.1 ± 1.9% (65.2 ± 20.5mmol/mol) (P < 0.05), with change in HbA1c from pre-lockdown levels being sustained throughout the second year of the pandemic. Over the same period, CGM use rose from 43% to 83%, primarily through increased uptake of intermittently scanned CGM, which is covered through the Ontario Drug Benefit program. Change in HbA1c was most evident in DexcomG6 real-time CGM users -0.7 ± 1.2% (-9.8 ± 17.1mmol/mol) (P < 0.01 vs. self-monitoring of blood glucose). Among emerging adults with type1 diabetes attending a multidisciplinary clinic in a high-income country, glycated hemoglobin levels are on average 0.4% (4.1mmol/mol) lower than they were before the pandemic. This reduction in HbA1c is unlikely to be a consequence of early strict lockdowns given the length of time of follow-up. Rather, improved glycemic control coincided with increased utilization of wearable diabetes devices.

Long-term effectiveness of advanced hybrid closed loop in children and adolescents with type 1 diabetes.

Advanced hybrid closed loop (AHCL) systems are the newest tool to improve metabolic control in type 1 diabetes (T1D). Long-term glycemic control of children and adolescents with T1D switching to MiniMed™ 780G in a real clinical setting was evaluated. Time in range (TIR) and in different glucose ranges, glycemic variability indexes, HbA1c and basal-bolus insulin distribution were evaluated in 44 subjects (mean age 14.2 ± 4.0 years, 22 males) during manual mode period, first 14 days (A14d) and first month after auto-mode activation (A1M), first 14 days after 3 months (A3M) and 6 months (A6M) in auto-mode. Mean TIR at A14d was 76.3 ± 9.6% versus 69.3 ± 12.6% in manual mode (p < 0.001), and this improvement was maintained over 6 months. Subjects with TIR >70% and >80% in manual mode were 45% and 23%, respectively, and increased to 80% (p=0.041) and 41% (p=0.007) at A14d. Basal-bolus distribution changed in favor of bolus, and auto-correction boluses inversely correlated with TIR. HbA1c was 7.2 ± 0.7% (55 mmol/mol) at baseline and significantly improved after 3 months (6.7 ± 0.5%, 50 mmol/mol, p < 0.001) and 6 months (6.6 ± 0.5%, 49 mmol/mol, p < 0.001). TIR was higher in individuals >13 years at all time periods (p < 0.001). Glycemic target <120 mg/dl was associated with better TIR. AHCL MiniMed™ 780G allowed rapid and sustained improvement of glycemic control in young T1D patients, reaching recommended TIR. Teenagers showed good technology adherence with optimal TIR, maintained better over time compared to younger children. Stricter settings were associated with better metabolic control, without increase in severe hypoglycemia occurrence.

Continuous Subcutaneous Insulin Infusion in Type 1 Diabetes Mellitus Patients: Results from the Spanish National Registry.

Aim: To analyze the clinical effect of continuous subcutaneous insulin infusion (CSII) in type 1 diabetes mellitus (T1D) patients in the Spanish real-world scenario. Methods: All T1D patients on CSII registered in the SPAnish Insulin Pump (SPAIP) registry were included. The primary efficacy outcome was change in HbA1c during follow-up. Secondary efficacy outcomes included: insulin pump indications, diabetes complication rates, insulin and pump use, and continuous glucose monitoring (CGM) glycometrics. Patient data were typed through the web-based SPAIP registry. Results: Data from 2979 T1D patients treated with CSII were analyzed. The median age was 44 years (interquartile range [IQR] 34-52 years), and T1D duration was 27 years (IQR 18-35 years). The median duration of CSII therapy was 6 years (IQR 3-10 years). The main indications for treatment were suboptimal glycemic control (33.8%), hypoglycemia (22.1%), and increased glycemic variability (18.8%). Glycated hemoglobin decreased by 6 mmol/mol (95% CI, -5 to -6 mmol/mol, P < 0.001) [-0.5%, 95% CI, -0.4 to -0.5, P < 0.001] during the follow-up. The percentage of patients with severe hypoglycemia decreased from 14.9% to 0.9% (P < 0.001). We observed an inverse correlation between final HbA1c levels and CGM adherence (R = -0.24, P < 0.001) or percentage of time with active hybrid closed-loop functions (R = -0.25, P < 0.001). Conclusions: CSII treatment was associated with a sustained improvement in glycemic control in the Spanish population. This benefit was greater among patients with higher CGM or active hybrid closed-loop functions adherence. The protocol was publicly registered at ClinicalTrials.gov (NCT04761094).

Pancreatic islet transplantation in type 1 diabetes: 20-year experience from a single-centre cohort in Canada

Islet transplantation offers an effective treatment for selected people with type 1 diabetes and intractable hypoglycaemia. Long-term experience, however, remains limited. We report outcomes from a single-centre cohort up to 20 years after islet transplantation. This cohort study included patients older than 18 years with type 1 diabetes undergoing allogeneic islet transplantation between March 11, 1999, and Oct 1, 2019, at the University of Alberta Hospital (Edmonton, AB, Canada). Patients who underwent islet-after-kidney transplantation and islet transplantation alone or islet transplantation before whole-pancreas transplantation (follow-up was censored at the time of whole-pancreas transplantation) were included. Patient survival, graft survival (fasting plasma C-peptide >0·1 nmol/L), insulin independence, glycaemic control, and adverse events are reported. To identify factors associated with prolonged graft survival, recipients with sustained graft survival (≥90% of patient follow-up duration) were compared with those who had non-sustained graft survival (<90% of follow-up duration). Multivariate binary logistic regression analyses were done to determine predictors of sustained graft survival. Between March 11, 1999, and Oct 1, 2019, 255 patients underwent islet transplantation and were included in the analyses (149 [58%] were female and 218 [85%] were White). Over a median follow-up of 7·4 years (IQR 4·4-12·2), 230 (90%) patients survived. Median graft survival was 5·9 years (IQR 3·0-9·5), and graft failure occurred in 91 (36%) patients. 178 (70%) recipients had sustained graft survival, and 77 (30%) had non-sustained graft survival. At baseline, compared with patients with non-sustained graft survival, those with sustained graft survival had longer median type 1 diabetes duration (33·5 years [IQR 24·3-41·7] vs 26·2 years [17·0-35·5]; p=0·0003), median older age (49·4 years [43·5-56·1] vs 44·2 years [35·4-54·2]; p=0·0011), and lower median insulin requirements (0·53 units/kg per day [0·45-0·67] vs 0·59 units/kg per day [0·48-0·70]; p=0·032), but median HbA1c concentrations were similar (8·2% [7·5-9·0] vs 8·5% [7·8-9·2]; p=0·23). 201 (79%) recipients had insulin independence, with a Kaplan-Meier estimate of 61% (95% CI 54-67) at 1 year, 32% (25-39) at 5 years, 20% (14-27) at 10 years, 11% (6-18) at 15 years, and 8% (2-17) at 20 years. Patients with sustained graft survival had significantly higher rates of insulin independence (160 [90%] of 178 vs 41 [53%] of 77; p<0·0001) and sustained improvements in glycaemic control mixed-main-effects model group effect, p<0·0001) compared with those with non-sustained graft survival. Multivariate analyses identified the combined use of anakinra plus etanercept (adjusted odds ratio 7·5 [95% CI 2·7-21·0], p<0·0001) and the BETA-2 score of 15 or higher (4·1 [1·5-11·4], p=0·0066) as factors associated with sustained graft survival. In recipients with sustained graft survival, the incidence of procedural complications was lower (23 [5%] of 443 infusions vs 17 [10%] of 167 infusions; p=0·027), whereas the incidence of cancer was higher (29 of [16%] of 178 vs four [5%] of 77; p=0·015) than in those with non-sustained graft survival; most were skin cancers (22 [67%] of 33). End-stage renal disease and severe infections were similar between groups. We present the largest single-centre cohort study of long-term outcomes following islet transplantation. Although some limitations with our study remain, such as the retrospective component, a relatively small sample size, and the absence of non-transplant controls, we found that the combined use of anakinra plus etanercept and the BETA-2 score were associated with improved outcomes, and therefore these factors could inform clinical practice. None.

Use of a Meter With Color-Range Indicators and a Mobile Diabetes Management App Improved Glycemic Control and Patient Satisfaction in an Underserved Hispanic Population: "Tu Salud"-A Randomized Controlled Partial Cross-Over Clinical Study.

ObjectiveTo demonstrate the clinical value of OneTouch (OT) Verio Flex glucose meter used in combination with a Spanish-language version of the OT Reveal mobile application (app) to support diabetes care and improve glycemic control in an underserved Hispanic population with type 2 diabetes.Research Design and MethodsTest subjects (n = 81) used the meter and app for 12 weeks, while a randomized control group (n = 39) used their own glucose meters without connection to an app. Thereafter, test subjects continued the same regimen for an additional 12 weeks to determine the durability of effect, and control subjects crossed over to use the new meter and app.ResultsTest subjects experienced a mean reduction in A1C of 1.0% after 12 weeks (P <0.001), a statistically significant greater reduction than in control subjects (P = 0.045). The improvement in A1C in test subjects was sustained over the next 12 weeks. Crossed-over subjects also demonstrated significant improvements in A1C (P <0.001). Mean blood glucose was reduced significantly without an increase in hypoglycemia, and results in range increased over 12 weeks of meter and mobile app use. Results were independent of subjects’ numeracy skills. Subjects using the new meter and app reacted favorably to the tools and expressed improvements in their diabetes treatment satisfaction based on Diabetes Treatment Satisfaction Questionnaire–Change scores.ConclusionUse of the OT meter and a Spanish-language version of its diabetes management app in an underserved population helped participants achieve a sustained improvement in glycemic control. The tools were well received by the subjects and may have important utility in other low-numeracy, low-literacy populations.

Implementation of an Intensive Telehealth Intervention for Rural Patients with Clinic-Refractory Diabetes.

BackgroundRural patients with type 2 diabetes (T2D) may experience poor glycemic control due to limited access to T2D specialty care and self-management support. Telehealth can facilitate delivery of comprehensive T2D care to rural patients, but implementation in clinical practice is challenging.ObjectiveTo examine the implementation of Advanced Comprehensive Diabetes Care (ACDC), an evidence-based, comprehensive telehealth intervention for clinic-refractory, uncontrolled T2D. ACDC leverages existing Veterans Health Administration (VHA) Home Telehealth (HT) infrastructure, making delivery practical in rural areas.DesignMixed-methods implementation study.Participants230 patients with clinic-refractory, uncontrolled T2D.InterventionACDC bundles telemonitoring, self-management support, and specialist-guided medication management, and is delivered over 6 months using existing VHA HT clinical staffing/equipment. Patients may continue in a maintenance protocol after the initial 6-month intervention period.Main MeasuresImplementation was evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The primary effectiveness outcome was hemoglobin A1c (HbA1c).Key ResultsFrom 2017 to 2020, ACDC was delivered to 230 patients across seven geographically diverse VHA sites; on average, patients were 59 years of age, 95% male, 80% white, and 14% Hispanic/Latinx. Patients completed an average of 10.1 of 12 scheduled encounters during the 6-month intervention period. Model-estimated mean baseline HbA1c was 9.56% and improved to 8.14% at 6 months (− 1.43%, 95% CI: − 1.64, − 1.21; P < .001). Benefits persisted at 12 (− 1.26%, 95% CI: − 1.48, − 1.05; P < .001) and 18 months (− 1.08%, 95% CI − 1.35, − 0.81; P < .001). Patients reported increased engagement in self-management and awareness of glycemic control, while clinicians and HT nurses reported a moderate workload increase. As of this submission, some sites have maintained delivery of ACDC for up to 4 years.ConclusionsWhen strategically designed to leverage existing infrastructure, comprehensive telehealth interventions can be implemented successfully, even in rural areas. ACDC produced sustained improvements in glycemic control in a previously refractory population.Supplementary InformationThe online version contains supplementary material available at 10.1007/s11606-021-07281-8.

Universal Subsidized Continuous Glucose Monitoring Funding for Young People With Type 1 Diabetes: Uptake and Outcomes Over 2 Years, a Population-Based Study.

Continuous glucose monitoring (CGM) is increasingly used in type 1 diabetes management; however, funding models vary. This study determined the uptake rate and glycemic outcomes following a change in national health policy to introduce universal subsidized CGM funding for people with type 1 diabetes aged <21 years. Longitudinal data from 12 months before the subsidy until 24 months after were analyzed. Measures and outcomes included age, diabetes duration, HbA1c, episodes of diabetic ketoacidosis and severe hypoglycemia, insulin regimen, CGM uptake, and percentage CGM use. Two data sources were used: the Australasian Diabetes Database Network (ADDN) registry (a prospective diabetes database) and the National Diabetes Service Scheme (NDSS) registry that includes almost all individuals with type 1 diabetes nationally. CGM uptake increased from 5% presubsidy to 79% after 2 years. After CGM introduction, the odds ratio (OR) of achieving the HbA1c target of <7.0% improved at 12 months (OR 2.5, P < 0.001) and was maintained at 24 months (OR 2.3, P < 0.001). The OR for suboptimal glycemic control (HbA1c ≥9.0%) decreased to 0.34 (P < 0.001) at 24 months. Of CGM users, 65% used CGM >75% of time, and had a lower HbA1c at 24 months compared with those with usage <25% (7.8 ± 1.3% vs. 8.6 ± 1.8%, respectively, P < 0.001). Diabetic ketoacidosis was also reduced in this group (incidence rate ratio 0.49, 95% CI 0.33-0.74, P < 0.001). Following the national subsidy, CGM use was high and associated with sustained improvement in glycemic control. This information will inform economic analyses and future policy and serve as a model of evaluation diabetes technologies.

Ten-year outcomes of islet transplantation in patients with type 1 diabetes: Data from the Swiss-French GRAGIL network

To describe the 10-year outcomes of islet transplantation within the Swiss-French GRAGIL Network, in patients with type 1 diabetes experiencing high glucose variability associated with severe hypoglycemia and/or with functional kidney graft. We conducted a retrospective analysis of all subjects transplanted in the GRAGIL-1c and GARGIL-2 islet transplantation trials and analyzed components of metabolic control, graft function and safety outcomes over the 10-year period of follow-up. Forty-four patients were included between September 2003 and April 2010. Thirty-one patients completed a 10-year follow-up. Ten years after islet transplantation, median HbA1c was 7.2% (6.2-8.0) (55mmol/mol [44-64]) versus 8.0% (7.1-9.1) (64mmol/mol [54-76]) before transplantation (p<.001). Seventeen of 23 (73.9%) recipients were free of severe hypoglycemia, 1/21 patients (4.8%) was insulin-independent and median C-peptide was 0.6ng/ml (0.2-1.2). Insulin requirements (UI/kg/day) were 0.3 (0.1-0.5) versus 0.5 (0.4-0.6) before transplantation (p<.001). Median (IQR) β-score was 1 (0-4) (p<.05 when comparing with pre-transplantation values) and 51.9% recipients had a functional islet graft at 10years. With a 10-year follow-up in a multicentric network, islet transplantation provided sustained improvement of glycemic control and was efficient to prevent severe hypoglycemia in almost 75% of the recipients.

Two-year use of flash glucose monitoring is associated with sustained improvement of glycemic control and quality of life (FLARE-NL-6)

IntroductionThe FreeStyle Libre (FSL) is a flash glucose monitoring (FGM) system. The Flash Monitor Register in the Netherlands (FLARE-NL-4) study previously demonstrated the positive effects of FSL-FGM use during 1...

Long-term impact of bariatric surgery on glycemic control and glucose-lowering therapy for people with type 2 diabetes: population-based cohort study

Randomized controlled trials (RCTs) have demonstrated that bariatric surgery improves glycemic control among people with diabetes. However, evidence from RCTs may not be generalizable to real-world clinical care with unselected patients in routine clinical practice. To examine long-term glycemic control and glucose-lowering drug regimens following bariatric surgery for people with type 2 diabetes (T2D) in unselected patients in routine clinical practice. Population-based cohort study using linked routinely collected real-world data from Ontario, Canada. Individuals with T2D who were assessed for bariatric surgery at any referral center in the province between February 2010 and November 2016 were identified and divided into those who received surgery within 2 years of the initial assessment and those who did not. There were 3674 people who had bariatric surgery and 1335 who did not. By 2 years, people who had undergone surgery had a significantly lower HbA1C (6.3 ± 1.2 % versus 7.8 ± 1.8 %, P < .0001), and this difference persisted at 3, 4, 5, and 6 years. Even by 6 years, half of those who had undergone surgery remained on no glucose-lowering drugs, and they were nearly 6 times less likely to be on insulin than those who had not undergone surgery. In real-world clinical care, bariatric surgery was associated with large and sustained improvements in glycemic control.

21-OR: Implementation of an Intensive Telehealth Intervention for Rural Patients with Uncontrolled Diabetes

Background: In rural areas, lack of access to specialty care and intensive self-management programs may perpetuate poor diabetes outcomes. Telehealth presents an opportunity to extend specialized diabetes care to rural areas, but may be difficult to implement in routine practice. We examined rural implementation of an intensive telehealth intervention designed to leverage existing Veterans Health Administration (VHA) Home Telehealth (HT) infrastructure for patients with uncontrolled type 2 diabetes despite receiving routine care. Methods: Advanced Comprehensive Diabetes Care (ACDC) is a 6-month telehealth intervention for patients with poor glycemic control (varies by site, typically ≥8.5%), established as effective in a prior randomized trial. ACDC combines telemonitoring, self-management support, and clinician-guided medication management, and is delivered by clinical HT nurses using standard HT equipment. During 2017-2019, we implemented and evaluated ACDC at 5 rural VHA sites with guidance from the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Results: From 2017-2019, 30-100% of eligible patients at each site were enrolled in ACDC, for a total of 125 patients (94% male, 89% white, 71% classified as rural/highly rural). Across sites, mean HbA1c improved from 9.25% at baseline to 7.89% at 6 months (-1.36%, 95% CI: -1.61,-1.11; p&amp;lt;0.001), a benefit that persisted at 12 (-1.22%, 95% CI: -1.48,-0.97; p&amp;lt;0.001) and 18 months (-1.07%, 95% CI -1.40,-0.73; p&amp;lt;0.001). Implementation at each site was acceptable, with an average of 8-10 of 12 scheduled ACDC calls completed. Qualitatively, ACDC enhanced patient engagement and awareness of glycemic control, while moderately increasing workload for providers. Conclusions: When strategically designed to use existing infrastructure, intensive telehealth interventions are conducive to implementation and produce sustained improvements in glycemic control among rural patients. Disclosure E.A. Kobe: None. A. Lewinski: None. S. Danus: None. E.L. Sidoli: None. B. Greck: None. L.C. Horne: None. D. Saxon: None. S.D. Shook: None. L.E. Aguirre: None. C. Evenson: None. C.S. Elizagaray: None. G.L. Jackson: None. H.B. Bosworth: Board Member; Self; Preventric Diagnostic. Consultant; Self; Abbott, Medicines Company, Novartis Pharmaceuticals Corporation. Research Support; Self; improved patient outcomes, Novo Nordisk Foundation, Otsuka Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Pharma foundation, Proteus Digital Health, Proteus Digital Health, Sanofi. D. Edelman: None. M. Crowley: None. Funding VA Office of Rural Health; Veterans Rural Health Resource Center-Iowa City (13366); National Center for Advancing Translation Sciences (TL1TR002555); VA Health Services Research and Development Service (IIR 16-213, 08-027); U.S. Department of Veterans Affairs (TPH 21-000); Durham Center of Innovation to Accelerate Discovery and Practice Transformation (CIN 13-410)

Long-Term Safety and Effectiveness of Linagliptin in Japanese Patients with Type 2 Diabetes and Renal Dysfunction: a Post-Marketing Surveillance Study.

IntroductionInternational clinical trials have shown that linagliptin significantly improves glycemic control and can be used at a single dose regardless of renal function in patients with type 2 diabetes (T2D). However, to date, no studies have evaluated the use of linagliptin in Japanese patients with T2D by renal function in routine clinical care.MethodsThis was a subgroup analysis of data from a prospective observational post-marketing surveillance (PMS) study of linagliptin conducted in Japan that evaluated the safety and effectiveness of linagliptin in routine clinical care for 3 years in Japanese patients with T2D. The subgroup analysis examined the patient population of this PMS study according to renal function using estimated glomerular filtration rate (eGFR) data. The incidence of linagliptin-related adverse events (adverse drug reactions [ADRs]) was the primary endpoint, and the change in glycated hemoglobin (HbA1c) from baseline to last observation was the secondary endpoint.ResultsOf the 2235 patients included in the safety analysis, eGFR was ≥ 90 mL/min/1.73 m2 (defined as group G1) in 16.9% (n = 377), ≥ 60 to < 90 mL/min/1.73 m2 (group G2) in 44.5% (n = 995), ≥ 30 to < 60 mL/min/1.73 m2 (group G3) in 21.7% (n = 486), ≥ 15 to < 30 mL/min/1.73 m2 (group G4) in 2.6% (n = 58) and < 15 mL/min/1.73 m2 (group G5) in 1.7% (n = 37). No eGFR data were available for 12.6% (n = 282) of patients. In these GFR groups, the incidence of ADRs with linagliptin was 6.9% in group G1, 11.1% in group G2, 13.8% in group G3, 15.5% in group G4 and 16.2% in group G5; the change in HbA1c from baseline to the last observation was − 1.11, − 0.64, − 0.35, − 0.46 and − 0.54% in the respective subgroups.ConclusionsLong-term linagliptin use showed sustained improvements in glycemic control with no new safety concerns regardless of renal function.Trial RegistrationClinicalTrials.gov (NCT01650259).FundingThis study was funded by Nippon Boehringer Ingelheim Co., Ltd. and Eli Lilly Japan K.K.Electronic Supplementary MaterialThe online version of this article (10.1007/s13300-019-00754-4) contains supplementary material, which is available to authorized users.

Continuous Subcutaneous Insulin Infusion in Adult Type 1 Diabetes Mellitus Patients: Results from a Public Health System.

Aims: To analyze prevalence and clinical effect of continuous subcutaneous insulin infusion (CSII) in adult type 1 diabetes mellitus (T1DM) patients in a public health system real-world scenario. Materials and Methods: All adult T1DM patients on CSII being followed at Castilla-La Mancha Health Public Service were included. Primary efficacy outcome was the change in HbA1c during the follow-up. Secondary efficacy outcomes included evaluation of the following variables: insulin pump indications, diabetes complication rates, insulin and pump use, continuous glucose monitoring use, patients achieving an HbA1c decrease ≥6 mmol/mol (0.5%) with or without severe hypoglycemia, and discontinuations. Direct patient data were typed through the web-based Spanish national registry on CSII therapy by nine diabetologists from eight different health care areas. Results: A total of 7% of T1DM adult patients were treated with insulin pumps in our region, with a regional prevalence of 18.7 CSII patients/100,000 inhabitants. Three hundred thirteen patients were analyzed with a mean age of 34.1 ± 11.0 years and T1DM duration of 16.6 ± 9.7 years. Mean duration of CSII therapy was 6.2 ± 4.0 years. Data completion was 91.2%. Main indications for treatment were high glucose variability (36%) and suboptimal glycemic control (32%). Mean duration of CSII therapy was 6.2 ± 4.0 years. Sensor-augment pump therapy was used by 26% of the patients. Glycated hemoglobin decreased to -5 mmol/mol (95% CI -6 to -3 mmol/mol; P < 0.001) during the follow-up (Mean difference in change -0.4%, 95% CI -0.5 to -0.2; P < 0.001). Percentage of patients with severe hypoglycemia decreased from 32% to 13% (P < 0.001). Frequent nonsevere hypoglycemia, severe hypoglycemia, and diabetic ketoacidosis were less frequent among patients using higher number of daily basal rates at the study end. The rate of CSII interruption was 3.8%. Conclusions: Prevalence of CSII therapy in our region remains under 10% of adult T1DM patients, although CSII treatment was associated with a sustained improvement in glycemic control.

1184-P: Efficacy of Hydroxychloroquine (HCQ) 400mg in Patients with Poorly Controlled Insulin-Treated Type 2 Diabetes Mellitus

Objective: We retrospectively investigated the effects of adding HCQ 400 mg in patients with type 2 diabetes showing sub-optimal control by basal insulin and other OHA therapy. Method: This is an open label, parallel group, retrospective and multicentre observational study. 123 patients with poorly controlled type 2 diabetes (baseline HbA1c 8.5 ± 0.6%) who are on basal insulin (glargine) with other OHA therapy (metformin 1gm+Sitagliptin 100 mg), were given HCQ 400 mg in addition to insulin. FPG, PPG and HbA1c values, daily insulin dose, body weight and the number of hypoglycemic events were recorded at weeks 0, 12 and 24. Result: HbA1c decreased by 1.6%, from 8.5 ± 0.6% to 6.9 ± 0.8% (P&amp;lt;0.0001) at 24 weeks. FPG and PPG was reduced significantly from 223.7 ± 31 to 121± 19 mg/dl and from 313.2 ± 41 to 161± 21 mg/dl at the end of 24 week (P&amp;lt;0.0001). Required insulin dose was reduced significantly from 29.4 ± 14.5 to 22.1 ± 12.1 units/day (P= 0.0187). Body weight decreased significantly from 69.5 ± 5.2 to 67.0 ± 6.7 kg, (P= 0.0232). Numbers of hypoglycemic events per patient per month were 0.25 ± 0.35. No severe hypoglycemia occurred during the study period. 56% patients achieved HbA1c ≤ 7% at 24 weeks. Conclusion: Administration of HCQ 400 mg resulted in sustained improvement in glycemic control when given as an adjunct to insulin therapy in patients with poorly controlled type 2 diabetes. Disclosure R. Ahmed: None. A. Sharma: None. A. Natarajan: None. D. Agarwal: None. A. Narayanan: None.

Randomized Trial of a Lifestyle Intervention for Urban Low-Income African Americans with Type 2 Diabetes.

African Americans suffer more than non-Hispanic whites from type 2 diabetes, but diabetes self-management education (DSME) has been less effective at improving glycemic control for African Americans. Our objective was to determine whether a novel, culturally tailored DSME intervention would result in sustained improvements in glycemic control in low-income African-American patients of public hospital clinics. This randomized controlled trial (n= 211) compared changes in hemoglobin A1c (A1c) at 6, 12, and 18months between two arms: (1) Lifestyle Improvement through Food and Exercise (LIFE), a culturally tailored, 28-session community-based intervention, focused on diet and physical activity, and (2) a standard of care comparison group receiving two group DSME classes. Cluster-adjusted ANCOVA modeling was used to assess A1c changes from baseline to 6, 12, and 18months, respectively, between arms. At 6months, A1c decreased significantly more in the intervention group than the control group (- 0.76 vs - 0.21%, p= 0.03). However, by 12 and 18months, the difference was no longer significant (12months - 0.63 intervention vs - 0.45 control, p= 0.52). There was a decrease in A1c over 18months in both the intervention (β= - 0.026, p= 0.003) and the comparison arm (β= - 0.018, p= 0.048) but no difference in trend (p= 0.472) between arms. The intervention group had greater improvements in nutrition knowledge (11.1 vs 6.0 point change, p= 0.002) and diet quality (4.0 vs - 0.5 point change, p= 0.018) while the comparison group had more participants with improved medication adherence (24% vs 10%, p< 0.05) at 12months. The LIFE intervention resulted in improved nutrition knowledge and diet quality and the comparison intervention resulted in improved medication adherence. LIFE participants showed greater A1c reduction than standard of care at 6months but the difference between groups was no longer significant at 12 and 18months. NCT01901952.

Efficacy and tolerability of exenatide once weekly over 7 years in patients with type 2 diabetes: An open-label extension of the DURATION-1 study

AimsTo investigate the glycemic efficacy, effects on cardiovascular risk factors, and safety of exenatide once weekly (QW) in patients with type 2 diabetes over 7 years in the DURATION-1 study. MethodsPatients were initially randomized to exenatide QW 2 mg or exenatide twice daily for 30 weeks, after which they received open-label, open-ended treatment with exenatide QW 2 mg for up to 7 years. Efficacy analyses included changes from baseline in glycated hemoglobin (HbA1C) and cardiovascular risk factors. ResultsOf 295 patients in the intention-to-treat population, 122 (41%) completed 7 years of treatment. Patients in the 7-year completer population showed sustained glycemic improvements from baseline (7-year least-squares mean [LSM] change in HbA1C, −1.53%) and significant improvements in several cardiovascular risk factors, including body weight, diastolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Seven-year completers who received no additional glucose-lowering therapies (n = 65 [53%]) had similar improvements in HbA1C, and numerically greater reductions in body weight (7-year LSM change, −6.46 kg vs −3.87 kg), compared with the overall cohort. There were no unexpected safety findings. ConclusionsTreatment with exenatide QW for 7 years was associated with sustained improvements in glycemic control and several cardiovascular risk factors.