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19 papers found.
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DEVOTE 3: temporal relationships between severe hypoglycaemia, cardiovascular outcomes and mortality

Aims/hypothesis The double-blind Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE) assessed the cardiovascular safety of insulin degludec. The incidence and rates of adjudicated severe hypoglycaemia, and all-cause mortality were also determined. This paper reports a secondary ...

Pharmacokinetic Properties of Liraglutide as Adjunct to Insulin in Subjects with Type 1 Diabetes Mellitus

A/S. Simon Heller has served as a consultant to Novo Nordisk, Eli Lilly, Sanofi, Boehringer– Ingelheim and Takeda, served on the speaker panel of Novo Nordisk, Eli Lilly, Sanofi, MSD, and Takeda, and

Estimation of individual beneficial and adverse effects of intensive glucose control for patients with type 2 diabetes

Aims/hypothesis Intensive glucose control reduces the risk of vascular complications while increasing the risk of severe hypoglycaemia at a group level. We sought to estimate individual beneficial and adverse effects of intensive glucose control in patients with type 2 diabetes. Methods We performed a post hoc analysis of the Action in Diabetes and Vascular Disease: Preterax and ...

Long-term Benefits of Intensive Glucose Control for Preventing End-Stage Kidney Disease: ADVANCE-ON

Stephen Harrap Simon Heller Stephen MacMahon Giuseppe Mancia Michel Marre David Matthews Bruce Neal Neil Poulter Anthony Rodgers Bryan Williams Sophia Zoungas for the ADVANCE-ON Collaborative Group

Uncovering the emotional aspects of working on a clinical trial: a qualitative study of the experiences and views of staff involved in a type 1 diabetes trial

Background The perspectives and experiences of trial staff are increasingly being investigated as these can be used to improve recruitment, adherence to trial protocols and support given to future staff. We interviewed staff working on a type 1 diabetes trial in order to aid interpretation of trial findings, inform recommendations for the rollout of the treatments investigated and ...

Comment on Doyle et al. Closed-Loop Artificial Pancreas Systems: Engineering the Algorithms. Diabetes Care 2014;37:1191–1197

. Evans,2 Roman Hovorka,2 Simon Heller,3 Desmond G. Johnston,1 Stephanie A. Amiel,4 and Katharine Barnard5 To effectively develop future diabetes technologies that meet these standards, robust and

Insulin degludec is not associated with a delayed or diminished response to hypoglycaemia compared with insulin glargine in type 1 diabetes: a double-blind randomised crossover study

lecture fees from Novo Nordisk, AstraZeneca, Bristol-Myers Squibb and Eli Lilly. Simon Heller has received: consulting fees from Abbott, Amylin, AstraZeneca, Eli Lilly, Johnson and Johnson, Mannkind, Novo

Once-Weekly Exenatide Versus Once- or Twice-Daily Insulin Detemir: Randomized, open-label, clinical trial of efficacy and safety in patients with type 2 diabetes treated with metformin alone or in combination with sulfonylureas

OBJECTIVE This multicenter, open-label, parallel-arm study compared the efficacy and safety of exenatide once weekly (EQW) with titrated insulin detemir in patients with type 2 diabetes inadequately controlled with metformin (with or without sulfonylureas).

A Psychoeducational Program to Restore Hypoglycemia Awareness: The DAFNE-HART Pilot Study

OBJECTIVE To develop and pilot a novel intervention addressing motivational and cognitive barriers to avoiding hypoglycemia in people with type 1 diabetes and persistent impaired awareness of hypoglycemia (IAH) despite training in flexible insulin therapy.

Impact of age, age at diagnosis and duration of diabetes on the risk of macrovascular and microvascular complications and death in type 2 diabetes

Aims/hypothesis Data are inconsistent regarding the associations between age, age at diagnosis of diabetes, diabetes duration and subsequent vascular complications. Methods The associations between age (or age at diagnosis), diabetes duration and major macrovascular events, all-cause death and major microvascular events were examined in 11,140 patients with type 2 diabetes randomly ...

Improved Biomedical and Psychological Outcomes 1 Year After Structured Education in Flexible Insulin Therapy for People With Type 1 Diabetes: The U.K. DAFNE experience

OBJECTIVE DAFNE (Dose Adjustment For Normal Eating), a structured education program in flexible insulin therapy, has been widely adopted in the U.K. after validation in a randomized trial. To determine benefits in routine practice, we collected biomedical and psychological data from all participants attending during a 12-month period.

Structured Type 1 Diabetes Education Delivered Within Routine Care: Impact on glycemic control and diabetes-specific quality of life

OBJECTIVE To determine whether improvements in glycemic control and diabetes-specific quality of life (QoL) scores reported in research studies for the type 1 diabetes structured education program Dose Adjustment For Normal Eating (DAFNE) are also found when the intervention is delivered within routine U.K. health care.

Linguistic and Psychometric Validation of the Diabetes-Specific Quality-of-Life Scale in U.K. English for Adults With Type 1 Diabetes

DEBBIE COOKE PHD MARY CLARE O'HARA MSC NAOMI BEINART MSC SIMON HELLER DM ROBERTO LA MARCA PHD MOLLY BYRNE PHD PETER MANSELL DM DPHIL OBJECTIVEdTo develop a linguistically and psychometrically

Does Glycemic Control Offer Similar Benefits Among Patients With Diabetes in Different Regions of the World?: Results from the ADVANCE trial

MARK WOODWARD PHD ANUSHKA PATEL PHD SOPHIA ZOUNGAS PHD LISHENG LIU CHANGYU PAN NEIL POULTER ANDRZEJ JANUSZEWICZ NIKHIL TANDON PHD PRASHANT JOSHI SIMON HELLER BRUCE NEAL PHD JOHN CHALMERS PHD

Does self monitoring of blood glucose as opposed to urinalysis provide additional benefit in patients newly diagnosed with type 2 diabetes receiving structured education? The DESMOND SMBG randomised controlled trial protocol

Kamlesh Khunti 2 Melanie J Davies Simon Heller 0 Diabetes Research Department, University Hospitals of Leicester NHS Trust , Leicester , UK 1 AHP Research , Hornchurch , UK/The Australian Centre for 2

Hypoglycemia in Type 1 Diabetic Pregnancy: Role of preconception insulin aspart treatment in a randomized study

SIMON HELLER PETER DAMM DMSC HENRIETTE MERSEBACH PHD TRINE VANG SKJTH RISTO KAAJA PHD MOSHE HOD SANTIAGO DUR AN-GARCA PHD DAVID MCCANCE ELISABETH R. MATHIESEN DMSC OBJECTIVE - A recent randomized

Combined Effects of Routine Blood Pressure Lowering and Intensive Glucose Control on Macrovascular and Microvascular Outcomes in Patients With Type 2 Diabetes: New results from the ADVANCE trial

SOPHIA ZOUNGAS PHD BASTIAAN E. DE GALAN PHD TOSHIHARU NINOMIYA PHD DIEDERICK GROBBEE PHD PAVEL HAMET PHD SIMON HELLER STEPHEN MACMAHON DSC PHD OBJECTIVE To assess the magnitude and independence of

Maternal Glycemic Control and Hypoglycemia in Type 1 Diabetic Pregnancy: A randomized trial of insulin aspart versus human insulin in 322 pregnant women

OBJECTIVE—To assess the safety and efficacy of insulin aspart (IAsp) versus regular human insulin (HI) in basal-bolus therapy with NPH insulin in pregnant women with type 1 diabetes. RESEARCH DESIGN AND METHODS—Subjects (n = 322) who were pregnant or planning pregnancy were randomized to IAsp or HI as meal-time insulin in an open-label, parallel-group, multicenter study. Subjects ...