Timothy Bailey

Background SAR341402 insulin aspart (SAR-Asp) is a rapid-acting insulin analog developed as an interchangeable biosimilar to the marketed insulin aspart reference product (NovoLog; NN-Asp). GEMELLI X was a randomized controlled trial to assess outcomes with a biosimilar in line with the US Food and Drug Administration requirements for designation a...

Comparing the performance of different continuous glucose monitoring (CGM) systems is challenging due to the lack of comprehensive guidelines for clinical study design. In particular, the absence of concise requirements for the distribution of comparator (reference) blood glucose (BG) concentrations and their rate of change (RoC), that are used to...

IntroductionTo evaluate time in range metrics and HbA1c in people with type 2 diabetes (T2D) treated with ultra rapid lispro (URLi) using continuous glucose monitoring (CGM) for the first time in this population.Methods This was a Phase 3b, 12-week, single-treatment study in adults with T2D on basal-bolus multiple daily injection (MDI) therapy usin...

Aims: Severe hypoglycaemia (SH) remains common in type 1 diabetes (T1D). SH can be treated with glucagon, but its cost, short shelf life and difficulty of preparation and administration make glucagon underused. Dasiglucagon is a glucagon analogue available in a ready-to-use aqueous formulation. This is an integrated analysis of the safety and effi...

Hyperglucagonemia contributes to hyperglycemia in patients with type 1 diabetes (T1D); however, novel therapeutics that block glucagon action could improve glycemic control. This phase 2 study evaluated the safety and efficacy of volagidemab, an antagonistic monoclonal glucagon receptor (GCGR) antibody, as an adjunct to insulin therapy in adults wi...

Objective: A CGM sensor that is disposable and requires no calibration may make glucose management easier for people living with diabetes. The present study reports on the interim analysis of a new disposable zero-calibration sensor in adults and youth with type 1 (T1D) or type 2 diabetes (T2D) . Methods: A prospective study enrolled individuals (N...

There is limited data on the performance of point of care HbA1c assays when fingerstick samples are tested by intended users in CLIA waived settings. This study evaluated the precision of the Afinion HbA1c Dx (Afinion) when performed at CLIA waived sites (N=5) by operators with no laboratory training. The operators (N=12) self-trained using the mat...

Aims: In people with type 2 diabetes mellitus (PWD2) suboptimally controlled with GLP-1 receptor agonist (GLP-1 RA) therapy, addition of basal insulin (BI) is recommended. However, real-world data on the addition of BI to GLP-1 RA therapy are limited. Materials and methods: We used a US electronic medical record data source (IBM® Explorys®) of a...

Background Accuracy of a seventh-generation “G7” continuous glucose monitoring (CGM) system was evaluated in children and adolescents with type 1 diabetes (T1D). Methods Sensors were worn on the upper arm and abdomen. The CGM data were available from 127 of 132 participants, ages 7 to 17 years, across 10.5 days of use, various glucose concentratio...

Purpose A proposal that an Insulin Advisory Committee develop insulin titration guidelines 100 years after its discovery. Findings Glucose control metrics remain poor despite significant advances in diabetes technology. Summary A century after the introduction of insulin, health care providers and patients with type 1 diabetes have worldwide acce...

Background: A composite metric for the quality of glycemia from continuous glucose monitor (CGM) tracings could be useful for assisting with basic clinical interpretation of CGM data. Methods: We assembled a data set of 14-day CGM tracings from 225 insulin-treated adults with diabetes. Using a balanced incomplete block design, 330 clinicians who...

Background: Standard insulin infusion sets (IISs) are to be replaced every two-to-three days to avoid complications and diabetic ketosis due to set failure. This pivotal trial evaluated the safety and performance of a new extended-wear infusion set (EIS) when used for seven days by adults with type 1 diabetes (T1D). Method: This single-arm, non-...

Background: Severe hypoglycemic episodes are life-threatening events demanding rapid administration of glucagon by a caregiver or bystander. The glucagon analog dasiglucagon is stable in aqueous formulation and therefore suitable for delivery in a ready-to-use autoinjector, potentially increasing speed and ease of use compared with standard glucag...

Background: ACHIEVE Control, a prospective, open-label, randomized, pragmatic, real-life study in insulin-naive people with type 2 diabetes (A1C 8.0-11.0%), demonstrated superiority of insulin glargine 300 units/mL (Gla-300) versus first-generation standard-of-care basal insulin (SOC-BI; glargine 100 units/mL or insulin detemir) in achieving indiv...

Aims To compare 12-month clinical effectiveness of insulin glargine 300 units/mL (Gla-300) versus first-generation basal insulin analogues (BIAs) (insulin glargine 100 units/mL [Gla-100] or insulin detemir [IDet]) in patients with type 2 diabetes (T2D) who were at high risk of hypoglycaemia and switched from one BIA to a different one (Gla-300 or G...

Background: Use of continuous glucose monitoring (CGM) systems is being rapidly adopted as standard of care for insulin-requiring patients with diabetes. The PROMISE study (NCT03808376) evaluated the accuracy and safety of the next-generation implantable Eversense CGM system for up to 180 days. Methods: This was a prospective multicenter study invo...

Continuous glucose monitoring devices have significantly improved in many respects compared with earlier versions. As sensor accuracy improved, U.S. Food and Drug Administration approved a nonadjunctive indication for use that no longer required confirmatory blood glucose monitoring. This article discusses the performance characteristics and regula...

In adults with overweight or obesity, semaglutide 2.4 mg as an adjunct to IBT led to significantly greater weight loss and improvements in CVD risk factors and glucose metabolism vs. placebo plus IBT. Publication History Publication Date: 24 September 2021 (online) © 2021. Thieme. All rights reserved. Georg Thieme Verlag KG Rüdigerstraße 14, 70469...

Abnormal regulation of glucagon secretion contributes to impaired glycemic control in patients with T1D. We conducted two 12-week, double-blind, randomized, placebo-controlled trials to evaluate the efficacy of blocking glucagon action with the glucagon receptor antagonist antibody, volagidemab (VOLA), on glycemic control in patients with T1D. In b...

No point of care HbA1c (A1c) assays are CLIA waived for use in diagnosing diabetes. The accuracy of the Abbott Afinion HbA1c Dx (Afinion) was evaluated for this purpose. Operators with no laboratory training (N=21) tested fingerstick (FS) and venous (V) whole blood samples from subjects at 7 CLIA waived sites with 2 Afinion analyzer models (AS100 a...

Aim: To confirm the efficacy and safety of dasiglucagon when administered via an autoinjector device. Materials and methods: In this double-blind trial, 45 participants with type 1 diabetes were randomized 3:1 to receive a single subcutaneous dose of dasiglucagon 0.6 mg or placebo following controlled induction of hypoglycaemia. The primary endp...

Background: Dasiglucagon, a next-generation, ready-to-use aqueous glucagon analog formulation, has been developed to treat severe hypoglycemia in individuals with diabetes. Objective: The aim of this trial was to evaluate the safety and efficacy of dasiglucagon in pediatric individuals with type 1 diabetes (T1DM). Participants were children and...

Importance Weight loss improves cardiometabolic risk factors in people with overweight or obesity. Intensive lifestyle intervention and pharmacotherapy are the most effective noninvasive weight loss approaches. Objective To compare the effects of once-weekly subcutaneous semaglutide, 2.4 mg vs placebo for weight management as an adjunct to intensi...

The outside back cover image is based on the Original Article A pragmatic randomized clinical trial of insulin glargine 300 U/mL versus first‐generation basal insulin analogues in insulin‐naïve adults with type 2 diabetes: 6‐month outcomes of ACHIEVE Control by Luigi F. Meneghini et al., https://doi.org/10.1111/dom.14152.

Background: In this study, we evaluated the analytical performance of the second-generation factory-calibrated FreeStyle Libre Flash Glucose Monitoring (FreeStyle Libre 2) System compared to plasma venous blood glucose reference, Yellow Springs Instrument 2300 (YSI). Methods: The study enrolled participants aged four and above with type 1 or typ...

Background: Diabetes-related distress is common among persons affected by diabetes and is associated with suboptimal glycemic control and complications, thus constituting a relevant patient-report outcome (PRO). Improving glycemic control may reduce diabetes distress and improve treatment satisfaction. This post hoc analysis evaluated PRO data for...

Aims: To compare the safety and efficacy of insulin glargine 300 U/mL (Gla-300) versus first-generation standard-of-care basal insulin analogues (SOC-BI; insulin glargine 100 U/mL or insulin detemir) at 6 months. Methods: In the 12-month, open-label, multicentre, randomized, pragmatic ACHIEVE Control trial, insulin-naïve adults with type 2 diabe...

Aims: ACHIEVE Control, a prospective pragmatic randomised real-life study in insulin-naïve adults with type 2 diabetes (T2D), demonstrated statistical superiority of insulin glargine 300 U/mL (Gla-300) over first-generation standard-of-care basal insulin analogues (SOC-BI; insulin glargine 100 U/mL or insulin detemir) for the primary composite end...

Dasiglucagon is a stable glucagon analog being developed in the HypoPal® auto-injector to address the need for easy-to-use, fast and effective treatment of severe hypoglycemia in individuals with diabetes. In this pediatric Phase 3 trial, ZP4207-17086, the clinical efficacy and safety of 0.6 mg dasiglucagon administered subcutaneously (SC) (same do...

Severe hypoglycemia is a major concern for patients with diabetes on insulin therapy. Rescue requires caregivers to provide effective treatment, including glucagon injections. Dasiglucagon is a stable glucagon analog in development to be administered with the HypoPal® auto-injector for treatment of severe hypoglycemia. This phase 3 trial, ZP4207-17...

For most people with type 2 diabetes (T2D), treatment intensification with the addition of basal insulin therapy is required to maintain glycaemic control. However, this often does not happen in real‐life practice promoting the development of long‐term diabetes‐related complications. The second‐generation basal insulin analogues glargine 300 U/mL (...

Objective: To compare real-world outcomes with newer (insulin glargine 300 U/mL; Gla-300) versus standard of care (SoC) basal insulins (BIs) in the REACH (insulin-naïve; NCT02967224) and REGAIN (basal insulin-treated; NCT02967211) studies in participants with uncontrolled type 2 diabetes (T2DM) in Europe and Brazil. Methods: In these open-label, pa...

Introduction iGlarLixi is a titratable, fixed-ratio combination of insulin glargine (iGlar, 100 units/ml) and the glucagon-like peptide-1 receptor agonist lixisenatide for the treatment of patients with type 2 diabetes. This post hoc analysis of the phase 3 LixiLan-L trial (NCT02058160) investigated baseline characteristics, glycemic control, and s...

Aims: To compare the second-generation basal insulin glargine 300 units/mL (Gla-300) and first-generation basal insulins on glycaemic control and hypoglycaemia risk in older adults with type 2 diabetes (T2D). Materials and methods: DELIVER 3 was a retrospective observational cohort study of electronic medical records. A total of 1176 older adult...

ADA ePoster: https://ada.apprisor.org/epsAbstractADA.cfm?id=1 We evaluated the accuracy of FreeStyle Libre 14-day system with new glucose algorithm in adults ages 18 years or older. This was a non-randomized, multi-center, single-arm study that enrolled 144 subjects with types 1 and 2 diabetes on intensive insulin therapy at 5 U.S. sites. Subjects...

The LIGHTNING study predictive modeling of U.S. health record data previously predicted similar severe hypoglycemia rates with insulin glargine 300 U/mL (Gla-300) and insulin degludec 100 U/mL (IDeg) in T2DM, using methodology including hypothesis-free generation of subgroups automatically derived from all available data using machine learning algo...

Titration following initiation of BI tends to occur in the first 8-12 weeks. At this time, patients may be at risk of experiencing hypoglycemia, which itself may present a barrier to optimal glycemic control. BRIGHT was the first randomized controlled trial comparing efficacy and safety of two second-generation BI analogs in insulin-naïve patients...

DELIVER - High Risk study compared long-term clinical outcomes for patients with T2D and high hypoglycemia risk on first-generation BIs who were switched to Gla-300 or other first-generation BIs (other switchers). Electronic medical record data from the PHIE database were used. Eligible patients (age >18 years) had ≥1 criterion for high hypoglycemi...

Background: The MiniMed™ 670G system is FDA-approved and CE-marked for patients with T1D aged ≥7 years. Glycemic outcomes of patients aged 2-75 years with T1D using the system at home for 3 months were evaluated and compared. Methods: Data from 151 children (n=46, 2-6 years and n=105, 7-13 years) enrolled at 9 sites; and 124 adolescents and adults...

Aims To compare glycaemic control, hypoglycaemia, and treatment discontinuation of insulin glargine 300 units/mL (Gla‐300) and insulin degludec (IDeg) in a real‐world study of insulin‐naïve adults with type 2 diabetes (T2D). Materials and methods DELIVER Naive D was a retrospective observational study that used electronic medical record data from...

Background: Barriers to mealtime insulin include complexity, fear of injections, and lifestyle interference. This multicenter, randomized controlled trial evaluated efficacy, safety, and self-reported outcomes in adults with type 2 diabetes, inadequately controlled on basal insulin, initiating and managing mealtime insulin with a wearable patch ver...

Background: A prior study (PRECISE II) demonstrated that an implantable continuous glucose monitoring (CGM) system (Eversense® CGM System) provided accurate glucose readings through the 90-day sensor life with a favorable safety profile in participants with type 1 or type 2 diabetes (T1D, T2D). This study was performed to further characterize the a...

Objective: To evaluate the safety of in-home use of the MiniMed™ 670G system with SmartGuard™ technology in children with type 1 diabetes (T1D). Methods: Participants (N = 105, ages 7–13 years, mean age 10.8 ± 1.8 years) were enrolled at nine centers (eight in the United States and one in Israel) and completed a 2-week baseline run-in phase in Manu...

Aims To investigate the association between day‐to‐day fasting self‐monitored blood glucose (SMBG) variability and risk of hypoglycaemia in type 1 (T1D) and type 2 diabetes (T2D), and compare day‐to‐day fasting SMBG variability between treatments with insulin degludec (degludec) and insulin glargine 100 units/mL (glargine U100). Materials and meth...

Background: The Medtronic predictive low-glucose management (PLGM) algorithm automatically stops insulin delivery when sensor glucose (SG) is predicted to reach or fall below a preset low-glucose value within the next 30 min, and resumes delivery after hypoglycemia recovery. The present study evaluated the PLGM algorithm performance of the MiniMed...

Background: The majority of therapies have generally targeted fasting glucose control, and current mealtime insulin therapies have longer time action profiles than that of endogenously secreted insulin. The primary purpose of this study was to assess both glucose time-in-range (TIR: 70-180 mg/dL) and postprandial glucose excursions (PPGE) in 1-4 h...

Objectifs Des études antérieures ont montre une association entre une forte variabilité glycémique (VG) et un risque élevé de développer une hypoglycémie. La corrélation entre la variabilité intra-journalière et la survenue d’hypoglycémies a été étudiée dans deux études croisées, double aveugle, selon la stratégie « en treat to target »,comparant l...

Objectifs La relation entre les hypoglycémies et variabilités inter-journalière n’est pas établie, une analyse post-hoc a été réalisée afin d’évaluer la corrélation entre la variabilité glycémique inter-journalière de la glycémie à jeun (GAJ) en auto-mesure et la survenue d’hypoglycémies dans deux études menées en crossover et double aveugle, de tr...

Background: This study evaluated the safety and performance of the Guardian™ continuous glucose monitoring (CGM) system in children and adolescents with type 1 diabetes (T1D). Materials and methods: Subjects 2-18 years of age (mean ± standard deviation [SD] 13.1 ± 3.9 years) with T1D and duration of diagnosis ≥1 year were enrolled at 11 sites in...

Objective: Evaluate the efficacy and safety of the dual sodium-glucose cotransporter 1 (SGLT1) and SGLT2 inhibitor sotagliflozin in combination with optimized insulin in type 1 diabetes (T1D). Research design and methods: The inTandem1 trial, a double-blind, 52-week phase 3 trial, randomized North American adults with T1D to placebo (n = 268), s...

Objective: Cleared blood glucose monitor systems (BGMs) for personal use may not always deliver levels of accuracy currently specified by international and U.S. regulatory bodies. This study's objective was to assess the accuracy of 18 such systems cleared by the U.S. Food and Drug Administration representing approximately 90% of commercially avai...

In-home use of the MiniMed™ 670G system with SmartGuard™ technology for 3 months improved A1C, 24-hour, and overnight (10PM-7AM) glycemia in T1D patients ≥14 years.1 Recently, the system was shown to improve A1C and time in target range (TIR) (>70-180mg/dL, 3.9-10mmol/L) during 24-h and overnight periods in T1D children aged 7-13 years. Effect of t...

Sixty patients with T1D on multiple daily injections (MDI) were randomized in a multi-center study, stratified by A1c values (<8.5% or ≥ 8.5%) to the control arm using aspart (n=34) vs. TI group (n=26). Patients in the TI arm were advised to take extra inhalations at 1 and 2 hours after meals based on post-prandial blood glucose (PPBG) values. Base...

Sotagliflozin (SOTA) is a dual SGLT1 and SGLT2 inhibitor in development as adjunct therapy to insulin in T1D. In this double-blind, 52-week North American trial, 793 adults with T1D treated with multiple daily insulin injections (40%) or pump (60%) were randomized 1:1:1 to placebo (n=268), SOTA 200 mg (n=263) or SOTA 400 mg (n=262) once daily after...

Post-prandial hyperglycemia is difficult to control due to lack of an ideal prandial insulin. TI (Afrezza®) has the most rapid onset of action, lasts for 2 hours. Sixty patients with T1D on multiple daily injections (MDI) were randomized in a multi-center study, stratified by baseline A1c values (<8.5% or ≥ 8.5%) to the control group using aspart (...

This multicenter RCT compared clinical, subject-reported, and safety outcomes in T2D subjects on basal insulin (A1C 7.5-11%) initiating mealtime insulin with a wearable bolus insulin delivery patch (Patch, Calibra Medical) vs. an insulin pen (Pen, NovoLog FlexPen®). The Patch was applied at least every 3 days and delivered subcutaneous bolus insuli...

This multicenter RCT compared efficacy, safety, and User-/HCP-reported outcomes for adults with T2D (Users, A1C: 7.5-11%) on basal insulin initiating mealtime insulin with a wearable bolus insulin delivery patch (Patch, Calibra Medical, n=139) vs. an insulin pen (Pen, NovoLog FlexPen®, n=139). The Patch was applied at least every 3 days and deliver...

The CONTOUR®NEXT ONE BGM system (BGMS) includes a wireless-enabled BG meter that links to the CONTOUR®Diabetes app installed on a mobile device. The system, based on the IMB model, detects and reports patterns of BG readings and provides guidance for self-management. The IMB model emphasizes the need for actionable information, motivation to act, a...

Previous studies demonstrated the accuracy of the CONTOUR®NEXT ONE BGM system (BGMS), which includes a wireless-enabled BG meter that links to the CONTOUR®Diabetes app installed on a mobile device. The CONTOUR®Diabetes app Version 2 Prototype detects repeated behavioral patterns in testing results and reports them back to the user. By decision of t...

Activation of “suspend before low” in the Medtronic PLGM algorithm stops insulin delivery when sensor glucose (SG) is predicted to reach or fall below a preset low glucose limit in 30min. Basal insulin delivery automatically resumes once the algorithm detects an increasing SG trend. We evaluated the “suspend before low” feature of the MiniMed™ 670G...

The accuracy of the CONTOUR®NEXT ONE BGM system (BGMS), which includes a wireless-enabled BG meter that links to the CONTOUR®Diabetes app installed on a mobile device, has been shown in previous studies. The CONTOUR®Diabetes app Version 2 Prototype detects repeated behavioral patterns in testing results and reports them back to the user. The user c...

Background: Persistent use of real-time continuous glucose monitoring (CGM) improves diabetes control in individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D). Methods: PRECISE II was a nonrandomized, blinded, prospective, single-arm, multicenter study that evaluated the accuracy and safety of the implantable Eversense CGM system amon...

In Reply The SWITCH 1 trial was the first trial, to our knowledge, to investigate hypoglycemia as a primary outcome in patients with type 1 diabetes, comparing insulin degludec with insulin glargine. Personalizing fasting blood glucose targets for patients remains important in clinical practice. However, in the trial, identical fasting blood glucos...

Bolus advisors that are designed to improve the accuracy of individual bolus doses relative to a meal’s carb content and the current glucose have not substantially changed since they were introduced 15 years ago despite an obvious need for enhancement and innovation. Although some glycemic benefits have been demonstrated, bolus advisors largely ign...

Background: This study evaluated the accuracy and performance of a fourth-generation subcutaneous glucose sensor (Guardian(™) Sensor 3) in the abdomen and arm. Methods: Eighty-eight subjects (14-75 years of age, mean ± standard deviation [SD] of 42.0 ± 19.1 years) with type 1 or type 2 diabetes participated in the study. Subjects wore two sensor...

Importance Hypoglycemia, common in patients with type 1 diabetes, is a major barrier to achieving good glycemic control. Severe hypoglycemia can lead to coma or death. Objective To determine whether insulin degludec is noninferior or superior to insulin glargine U100 in reducing the rate of symptomatic hypoglycemic episodes. Design, Setting, and...

Background: Predictions based on continuous glucose monitoring (CGM) data are the basis for automatic suspension and resumption of insulin delivery by a predictive low-glucose management feature termed "suspend before low," which is part of the Medtronic MiniMed(®) 640G combined insulin pump and CGM system. This study assessed the safety and perfo...

Background: These studies investigated the accuracy of the new Contour®Next ONE blood glucose monitoring system (BGMS) that is designed to sync with the Contour™ Diabetes app on a smartphone or tablet. Methods: A laboratory study tested fingertip capillary blood samples from 100 subjects in duplicate using 3 test strip lots, based on ISO 15197:2...

Background: The new Contour(®)Plus ONE blood glucose monitoring system (BGMS) features an easy-to-use, wireless-enabled blood glucose meter that links to a smart mobile device via Bluetooth(®) connectivity and can sync with the Contour(™) Diabetes app on a smartphone or tablet. Methods: The accuracy of the new BGMS was assessed in 2 studies acco...

Background: The safety and effectiveness of the in-home use of a hybrid closed-loop (HCL) system that automatically increases, decreases, and suspends insulin delivery in response to continuous glucose monitoring were investigated. Methods: Adolescents (n = 30, ages 14–21 years) and adults (n = 94, ages 22–75 years) with type 1 diabetes participate...