Latest & greatest articles for type 1 diabetes

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Top results for type 1 diabetes

101. Efficacy of two telemonitoring systems to improve glycaemic control during basal insulin initiation in patients with type 2 diabetes: The TeleDiab-2 randomised controlled trial Full Text available with Trip Pro

Efficacy of two telemonitoring systems to improve glycaemic control during basal insulin initiation in patients with type 2 diabetes: The TeleDiab-2 randomised controlled trial TeleDiab-2 was a 13-month randomized controlled trial evaluating the efficacy and safety of two telemonitoring systems to optimize basal insulin (BI) initiation in subjects with inadequately controlled type 2 diabetes (HbA1c, 7.5%-10%). A total of 191 participants (mean age 58.7 years, mean HbA1c 8.9%) were randomized (...) into three groups: group 1(G1, standard care, n = 63), group 2 (G2, interactive voice response system, n = 64) and group 3 (G3, Diabeo-BI app software, n = 64). The two telemonitoring systems proposed daily adjustments of BI doses, in order to facilitate the achievement of fasting blood glucose (FBG) values targeted at ~100 mg/dL. At 4 months follow-up, HbA1c reduction was significantly higher in the telemonitoring groups (G2: -1.44% and G3: -1.48% vs. G1: -0.92%; P < 0.002). Moreover, target FBG

2019 EvidenceUpdates

102. A 24-week, randomized, double-blind, active-controlled clinical trial comparing bexagliflozin with sitagliptin as an adjunct to metformin for the treatment of type 2 diabetes in adults (Abstract)

A 24-week, randomized, double-blind, active-controlled clinical trial comparing bexagliflozin with sitagliptin as an adjunct to metformin for the treatment of type 2 diabetes in adults To compare the relative safety and effectiveness of bexagliflozin and sitagliptin as adjuncts to metformin for the treatment of adults with type 2 diabetes.Participants (n = 386) were randomized to receive bexagliflozin (20 mg) or sitagliptin (100 mg) in addition to their existing doses of metformin. The primary (...) . The changes from baseline FPG, body mass and SBP were -1.82 mmol L-1 , -3.35 kg and -4.23 mmHg in the bexagliflozin arm and -1.45 mmol L-1 , -0.81 kg and -1.90 mmHg in the sitagliptin arm, respectively. These differences were significant for the first two measures (one-sided P = 0.0123, P < 0.0001 and P = 0.0276, respectively.) Adverse events were experienced by 47.1% of subjects in the bexagliflozin arm and 56.0% of subjects taking sitagliptin. Serious adverse events affected 3.7% of subjects

2019 EvidenceUpdates

103. Efficacy and safety of oral semaglutide with flexible dose adjustment versus sitagliptin in type 2 diabetes (PIONEER 7): a multicentre, open-label, randomised, phase 3a trial (Abstract)

Efficacy and safety of oral semaglutide with flexible dose adjustment versus sitagliptin in type 2 diabetes (PIONEER 7): a multicentre, open-label, randomised, phase 3a trial Oral semaglutide is the first oral formulation of a glucagon-like peptide-1 (GLP-1) receptor agonist developed for the treatment of type 2 diabetes. We aimed to compare the efficacy and safety of flexible dose adjustments of oral semaglutide with sitagliptin 100 mg.In this 52-week, multicentre, randomised, open-label (...) , phase 3a trial, we recruited patients with type 2 diabetes from 81 sites in ten countries. Patients were eligible if they were aged 18 years or older (19 years or older in South Korea), had type 2 diabetes (diagnosed ≥90 days before screening), HbA1c of 7·5-9·5% (58-80 mmol/mol), and were inadequately controlled on stable daily doses of one or two oral glucose-lowering drugs (for 90 days or more before screening). Participants were randomly assigned (1:1) by use of an interactive web-response system

2019 EvidenceUpdates

104. Type 2 diabetes remission 1 year after an intensive lifestyle intervention: A secondary analysis of a randomized clinical trial Full Text available with Trip Pro

Type 2 diabetes remission 1 year after an intensive lifestyle intervention: A secondary analysis of a randomized clinical trial To investigate whether an intensive lifestyle intervention induces partial or complete type 2 diabetes (T2D) remission.In a secondary analysis of a randomized, assessor-blinded, single-centre trial, people with non-insulin-dependent T2D (duration <10 years), were randomly assigned (2:1, stratified by sex, from April 2015 to August 2016) to a lifestyle intervention (...) group (n = 64) or a standard care group (n = 34). The primary outcome was partial or complete T2D remission, defined as non-diabetic glycaemia with no glucose-lowering medication at the outcome assessments at both 12 and 24 months from baseline. All participants received standard care, with standardized, blinded, target-driven medical therapy during the initial 12 months. The lifestyle intervention included 5- to 6-weekly aerobic and combined aerobic and strength training sessions (30-60 minutes

2019 EvidenceUpdates

105. Efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment (PIONEER 5): a placebo-controlled, randomised, phase 3a trial Full Text available with Trip Pro

Efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment (PIONEER 5): a placebo-controlled, randomised, phase 3a trial Oral semaglutide is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist for glycaemic control in patients with type 2 diabetes. Type 2 diabetes is commonly associated with renal impairment, restricting treatment options. We aimed to investigate the efficacy and safety of oral semaglutide in patients with type 2 diabetes (...) and moderate renal impairment.This randomised, double-blind, phase 3a trial was undertaken at 88 sites in eight countries. Patients aged 18 years and older, with type 2 diabetes, an estimated glomerular filtration rate of 30-59 mL/min per 1·73 m2, and who had been receiving a stable dose of metformin or sulfonylurea, or both, or basal insulin with or without metformin for the past 90 days were eligible. Participants were randomly assigned (1:1) by use of an interactive web-response system

2019 EvidenceUpdates

106. Effects of dapagliflozin on development and progression of kidney disease in patients with type 2 diabetes: an analysis from the DECLARE-TIMI 58 randomised trial (Abstract)

with type 2 diabetes both with and without established atherosclerotic cardiovascular disease and mostly with preserved renal function.In DECLARE-TIMI 58, patients with type 2 diabetes, HbA1c 6·5-12·0% (47·5-113·1 mmol/mol), with either established atherosclerotic cardiovascular disease or multiple risk factors, and creatinine clearance of at least 60 mL/min were randomly assigned (1:1) to 10 mg dapagliflozin or placebo once daily. A prespecified secondary cardiorenal composite outcome was defined (...) Effects of dapagliflozin on development and progression of kidney disease in patients with type 2 diabetes: an analysis from the DECLARE-TIMI 58 randomised trial Sodium-glucose co-transporter-2 (SGLT2) inhibitors have shown beneficial effects on renal outcomes mainly in patients with established atherosclerotic cardiovascular disease. Here we report analyses of renal outcomes with the SGLT2 inhibitor dapagliflozin in the DECLARE-TIMI 58 cardiovascular outcomes trial, which included patients

2019 EvidenceUpdates

107. Adjunctive liraglutide treatment in patients with persistent or recurrent type 2 diabetes after metabolic surgery (GRAVITAS): a randomised, double-blind, placebo-controlled trial (Abstract)

Adjunctive liraglutide treatment in patients with persistent or recurrent type 2 diabetes after metabolic surgery (GRAVITAS): a randomised, double-blind, placebo-controlled trial Many patients with type 2 diabetes do not achieve sustained diabetes remission after metabolic (bariatric) surgery for the treatment of obesity. Liraglutide, a glucagon-like peptide-1 analogue, improves glycaemic control and reduces bodyweight in patients with type 2 diabetes. Our aim was to assess the safety (...) and efficacy of liraglutide 1·8 mg in patients with persistent or recurrent type 2 diabetes after metabolic surgery.In the GRAVITAS randomised double-blind, placebo-controlled trial, we enrolled adults who had undergone Roux-en-Y gastric bypass or vertical sleeve gastrectomy and had persistent or recurrent type 2 diabetes with HbA1c levels higher than 48 mmol/mol (6·5%) at least 1 year after surgery from five hospitals in London, UK. Participants were randomly assigned (2:1) via a computer-generated

2019 EvidenceUpdates

108. Empaglifozin linagliptin fixed-dose combination (Glyxambi) - type 2 diabetes mellitus:

Empaglifozin linagliptin fixed-dose combination (Glyxambi) - type 2 diabetes mellitus: Published 12 August 2019 1 Product Update: empagliflozin plus linagliptin 10mg/5mg, 25mg/5mg film-coated tablets (Glyxambi ® ) SMC No. (1236/17) Boehringer Ingelheim Ltd. 07 April 2017 (Issued July 2019) The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHS Scotland. The advice (...) is summarised as follows: ADVICE: following an abbreviated submission empagliflozin/linagliptin (Glyxambi ® ) is accepted for restricted use within NHS Scotland. Indication under review: in adults aged 18 years and older with type 2 diabetes mellitus: ? To improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi ® do not provide adequate glycaemic control ? When already being treated with the free combination of empagliflozin and linagliptin SMC

2019 Scottish Medicines Consortium

109. Dietary fats and mortality among patients with type 2 diabetes: analysis in two population based cohort studies. Full Text available with Trip Pro

Dietary fats and mortality among patients with type 2 diabetes: analysis in two population based cohort studies. To assess the association of dietary fatty acids with cardiovascular disease mortality and total mortality among patients with type 2 diabetes.Prospective, longitudinal cohort study.Health professionals in the United States.11 264 participants with type 2 diabetes in the Nurses' Health Study (1980-2014) and Health Professionals Follow-Up Study (1986-2014).Dietary fat intake assessed (...) for other fats, isocalorically replacing 2% of energy from saturated fatty acids with total PUFAs or linoleic acid was associated with 13% (hazard ratio 0.87, 0.77 to 0.99) or 15% (0.85, 0.73 to 0.99) lower cardiovascular disease mortality, respectively. A 2% replacement of energy from saturated fatty acids with total PUFAs was associated with 12% (hazard ratio 0.88, 0.83 to 0.94) lower total mortality.In patients with type 2 diabetes, higher intake of PUFAs, in comparison with carbohydrates

2019 BMJ

110. Novel Smartphone Game Improves Physical Activity Behavior in Type 2 Diabetes (Abstract)

Novel Smartphone Game Improves Physical Activity Behavior in Type 2 Diabetes Many type 2 diabetes patients show insufficient levels of physical activity and are often unmotivated to change physical activity behaviors. This study investigated whether a newly developed smartphone game delivering individualized exercise and physical activity promotion through an elaborate storyline can generate sustained improvements in daily physical activity (steps/day).Thirty-six participants were enrolled (...) in this 24-week RCT between August 2016 and April 2018. After baseline assessment, participants were randomized in equal numbers to the intervention or control condition. Data analysis was performed in May-June 2018.Inactive, overweight type 2 diabetes patients, aged 45-70 years, were recruited through advertising and from hospitals and diabetes care centers in the Basel, Switzerland, metropolitan area.Participants were instructed to play the innovative smartphone game (intervention group

2019 EvidenceUpdates

111. Dapagliflozin Plus Saxagliptin Add-on Therapy Compared With Insulin in Patients With Type 2 Diabetes Poorly Controlled by Metformin With or Without Sulfonylurea Therapy: A Randomized Clinical Trial (Abstract)

weight.In a multinational, open-label, randomized, phase 3 trial (ClinicalTrials.gov reg. no. NCT02551874), adults with type 2 diabetes inadequately controlled on metformin, with or without sulfonylurea, were randomized (1:1) to receive dapagliflozin (DAPA) plus saxagliptin (SAXA) or titrated insulin glargine (INS). The primary end point was change in glycated hemoglobin A1c (HbA1c) from baseline to week 24. DAPA + SAXA treatment was tested for noninferiority versus INS.The efficacy data set included (...) Dapagliflozin Plus Saxagliptin Add-on Therapy Compared With Insulin in Patients With Type 2 Diabetes Poorly Controlled by Metformin With or Without Sulfonylurea Therapy: A Randomized Clinical Trial This study evaluated whether an oral combination of a sodium-glucose cotransporter 2 inhibitor and a dipeptidyl peptidase 4 inhibitor achieved glycemic control similar to basal insulin in patients with type 2 diabetes, poorly controlled with metformin, without increasing hypoglycemia or body

2019 EvidenceUpdates

112. Changes in Visceral and Subcutaneous Fat in Youth With Type 2 Diabetes in the TODAY Study (Abstract)

Changes in Visceral and Subcutaneous Fat in Youth With Type 2 Diabetes in the TODAY Study In the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study, metformin plus rosiglitazone (M + R) maintained glycemic control better than metformin alone (M) or metformin plus lifestyle (M + L) in youth with type 2 diabetes (T2D). We hypothesized that changes in visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) would explain the differential treatment effects (...) in adults with T2D, in TODAY, M + R resulted in the most VAT accumulation compared with M + L or M. Differential effects on depot-specific indirect measures of adiposity are unrelated to treatment effects in sustaining glycemic control. Additional studies are needed to understand the clinical markers of metabolic risk profile in youth with T2D on rosiglitazone.© 2019 by the American Diabetes Association.

2019 EvidenceUpdates

113. Determining the optimal fasting glucose target for patients with type 2 diabetes: results of the multicentre, open-label, randomized-controlled FPG GOAL trial Full Text available with Trip Pro

Determining the optimal fasting glucose target for patients with type 2 diabetes: results of the multicentre, open-label, randomized-controlled FPG GOAL trial The optimal fasting blood glucose (FBG) target of achieving HbA1c less than 7.0% in type 2 diabetes (T2D) patients remains controversial. This open-label trial randomized (1:3:3) 947 adults with uncontrolled T2D (HbA1c >7% to ≤10.5%) who were using one to three oral antidiabetic drugs to achieve an FBG target of 3.9 < FBG ≤5.6 mmol/L (...) %; P < 0.001) but was not in Group 2 vs Group 3 (27.5% vs 23.3%; P = 0.177). Clinically important hypoglycaemia (glucose ≤3.0 mmol/L) was reported in 4.8%, 2.0% and 3.8% of patients in Groups 1, 2 and 3, respectively. In conclusion, the optimal FBG target for most Chinese patients with T2D appears to be 3.9-6.1 mmol/L.© 2019 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

2019 EvidenceUpdates

114. Addition of canagliflozin to insulin improves glycaemic control and reduces insulin dose in patients with type 2 diabetes mellitus: A randomized controlled trial (Abstract)

Addition of canagliflozin to insulin improves glycaemic control and reduces insulin dose in patients with type 2 diabetes mellitus: A randomized controlled trial The aim of this study was to evaluate the efficacy of canagliflozin in reducing the required insulin dose and the risk of hypoglycaemia in type 2 diabetes (T2D). This study was conducted in patients with T2D treated with insulin. They were randomly assigned to the control (n = 17) and canagliflozin (n = 17, plus 100 mg/day

2019 EvidenceUpdates

115. Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial (Abstract)

Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial Hypoglycaemia unawareness and severe hypoglycaemia can increase fear of hypoglycaemia and the risk of subsequent hypoglycaemic events. We aimed to assess the safety and efficacy of insulin pump therapy with integrated continuous glucose monitoring (CGM) and a suspend-before-low feature (Medtronic MiniMed 640G with SmartGuard (...) ) in hypoglycaemia-prone adults with type 1 diabetes.SMILE was an open-label randomised controlled trial done in people aged 24-75 years with type 1 diabetes for 10 years or longer, HbA1c values of 5·8-10·0% (40-86 mmol/mol), and at high risk of hypoglycaemia (recent severe hypoglycaemia or hypoglycaemia unawareness defined by a Clarke or Gold score ≥4). Participants were enrolled from 16 centres (eg, clinics, hospitals, or university medical centres) in Canada, France, Italy, the Netherlands, and the UK. After

2019 EvidenceUpdates

116. GLP-1 receptor agonists: reports of diabetic ketoacidosis when concomitant insulin was rapidly reduced or discontinued

ketoacidosis has been reported in patients with type 2 diabetes on a combination of a GLP-1 receptor agonist and insulin who had doses of concomitant insulin rapidly reduced or discontinued. GLP-1 receptor agonists are not substitutes for insulin, and any reduction of insulin should be done in a stepwise manner with careful glucose self-monitoring. Abrupt discontinuation or reduction in insulin doses can lead to poor glycaemic control, with a risk of diabetic ketoacidosis. Published 19 June 2019 From (...) is recommended discuss with patients the risk factors for and signs and symptoms of diabetic ketoacidosis (see below) and advise them to seek immediate medical advice if these develop report suspected adverse drug reactions on a Background Exenatide ( , ), liraglutide ( , ▼, ▼[combination product with insulin]), and dulaglutide ( ▼) are glucagon-like peptide-1 (GLP-1) receptor agonists (also known as GLP-1 mimetic therapies) and are authorised for use in adults with type 2 diabetes to improve glycaemic

2019 MHRA Drug Safety Update

117. Triple therapy with low-dose dapagliflozin plus saxagliptin versus dual therapy with each monocomponent, all added to metformin, in uncontrolled type 2 diabetes Full Text available with Trip Pro

Triple therapy with low-dose dapagliflozin plus saxagliptin versus dual therapy with each monocomponent, all added to metformin, in uncontrolled type 2 diabetes To evaluate the efficacy and safety of triple therapy with low-dose dapagliflozin plus saxagliptin added to metformin in uncontrolled type 2 diabetes.This 24-week, double-blind trial (NCT02681094) randomized 883 patients (glycated haemoglobin [HbA1c] 7.5-10.0%) on metformin ≥1500 mg/d to add-on dapagliflozin 5 mg/d plus saxagliptin 5 mg (...) dapagliflozin 5 mg, saxagliptin 5 mg and metformin significantly improved glycaemic control versus dual therapy with either agent added to metformin in uncontrolled type 2 diabetes, and was generally well tolerated.© 2019 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

2019 EvidenceUpdates

118. Management of people with Type 2 diabetes shared between a specialized outpatient clinic and primary health care is noninferior to management in a specialized outpatient clinic: a randomized, noninferiority trial Full Text available with Trip Pro

Management of people with Type 2 diabetes shared between a specialized outpatient clinic and primary health care is noninferior to management in a specialized outpatient clinic: a randomized, noninferiority trial To evaluate whether management of people with Type 2 diabetes shared between a specialized outpatient clinic and primary health care has noninferior HbA1c outcomes compared with mono-sectorial management in a specialized outpatient clinic.A randomized controlled, noninferiority study (...) interval (CI) -1.3, 3.9] (0.1%, 90% CI -0.1, 0.4). Noninferiority was confirmed in both per protocol and intention to treat analyses.We found that our shared care programme was noninferior to specialized outpatient management in maintaining glycaemic control in this group of people with Type 2 diabetes. Shared care should be considered for the future diabetes management of Type 2 diabetes.© 2019 Diabetes UK.

2019 EvidenceUpdates

119. Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. Full Text available with Trip Pro

Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. Establishing cardiovascular safety of new therapies for type 2 diabetes is important. Safety data are available for the subcutaneous form of the glucagon-like peptide-1 receptor agonist semaglutide but are needed for oral semaglutide.We assessed cardiovascular outcomes of once-daily oral semaglutide in an event-driven, randomized, double-blind, placebo-controlled trial involving patients at high cardiovascular risk (...) of 1592 (1.0%), respectively (hazard ratio, 0.74; 95% CI, 0.35 to 1.57). Death from any cause occurred in 23 of 1591 patients (1.4%) in the oral semaglutide group and 45 of 1592 (2.8%) in the placebo group (hazard ratio, 0.51; 95% CI, 0.31 to 0.84). Gastrointestinal adverse events leading to discontinuation of oral semaglutide or placebo were more common with oral semaglutide.In this trial involving patients with type 2 diabetes, the cardiovascular risk profile of oral semaglutide was not inferior

2019 NEJM Controlled trial quality: predicted high

120. An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes. Full Text available with Trip Pro

An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes. Type 1 diabetes is a chronic autoimmune disease that leads to destruction of insulin-producing beta cells and dependence on exogenous insulin for survival. Some interventions have delayed the loss of insulin production in patients with type 1 diabetes, but interventions that might affect clinical progression before diagnosis are needed.We conducted a phase 2, randomized, placebo-controlled, double-blind trial (...) of teplizumab (an Fc receptor-nonbinding anti-CD3 monoclonal antibody) involving relatives of patients with type 1 diabetes who did not have diabetes but were at high risk for development of clinical disease. Patients were randomly assigned to a single 14-day course of teplizumab or placebo, and follow-up for progression to clinical type 1 diabetes was performed with the use of oral glucose-tolerance tests at 6-month intervals.A total of 76 participants (55 [72%] of whom were ≤18 years of age) underwent

2019 NEJM Controlled trial quality: predicted high