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Latest & greatest articles for type 1 diabetes
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Dapagliflozin (Forxiga) - type1diabetes mellitus 1 Published 9 September 2019 1 SMC2185 dapagliflozin 5mg film coated tablets (Forxiga®) AstraZeneca UK Ltd 9 August 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 NHSScotland. The advice is summarised as follows: ADVICE: following a full submission dapagliflozin (Forxiga®) is accepted for use within NHSScotland (...) . Indication under review: In adults for the treatment of insufficiently controlled type1diabetes mellitus as an adjunct to insulin in patients with BMI =27kg/m 2 , when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy. Dapagliflozin in combination with insulin improved glycaemic control compared with insulin alone in adult patients with inadequately controlled type1diabetes. Chairman Scottish Medicines Consortium www.scottishmedicines.org.uk 2 Indication
Canagliflozin and Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus and Chronic Kidney Disease in Primary and Secondary Cardiovascular Prevention Groups Canagliflozin reduces the risk of kidney failure in patients with type 2 diabetes mellitus and chronic kidney disease, but effects on specific cardiovascular outcomes are uncertain, as are effects in people without previous cardiovascular disease (primary prevention).In CREDENCE (Canagliflozin and Renal Events in Diabetes (...) With Established Nephropathy Clinical Evaluation), 4401 participants with type 2 diabetes mellitus and chronic kidney disease were randomly assigned to canagliflozin or placebo on a background of optimized standard of care.Primary prevention participants (n=2181, 49.6%) were younger (61 versus 65 years), were more often female (37% versus 31%), and had shorter duration of diabetes mellitus (15 years versus 16 years) compared with secondary prevention participants (n=2220, 50.4%). Canagliflozin reduced the risk
An evidence-based approach to developing low-carbohydrate diets for type 2 diabetes management: A systematic review of interventions and methods To identify core diet and delivery components of low-carbohydrate (CHO) diets that have demonstrated efficacy for type 2 diabetes (T2D) management.MEDLINE, Pre-MEDLINE, EMBASE, CINAHL and the Cochrane Library of Controlled Trials databases were systematically searched from inception until August 18, 2018. Primary intervention studies of low-CHO diets (...) . Thirty-one studies reported a total energy prescription, of which 18/31 encouraged ad libitum intakes. Twenty studies reported a prescribed dietary fat amount, of which 18/20 were unrestricted or high-fat (>35% TEI). Twenty-six studies reported a prescribed dietary protein amount, of which 22 were unrestricted or were high-protein (>25% TEI). The types of dietary CHO, fat and protein recommended were predominantly whole foods. Common delivery methods reported were dietician and/or physician
) outcomes trial. Participants with type 2 diabetes at high risk for CV events (n = 9,340) were randomized 1:1 to receive either liraglutide (≤1.8 mg daily; n = 4,668) or placebo (n = 4,672), with both groups also receiving standard care (treatment period: 3.5-5 years). Acute gallstone disease was a medical event of special interest. This post hoc analysis categorized captured events of acute gallbladder or biliary disease into four groups: uncomplicated gallbladder stones, complicated gallbladder stones (...) Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial To explore gallbladder- and biliary tract-related events reported for the liraglutide and placebo groups in the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial.LEADER was an international, randomized, double-blind, controlled cardiovascular (CV
HbA1c level as a risk factor for retinopathy and nephropathy in children and adults with type1diabetes: Swedish population based cohort study. To evaluate if the lowest target level for glycated haemoglobin (HbA1c) of <6.5% is associated with lower risk for retinopathy and nephropathy than less tight control in children and adults with type1 diabetes.Population based cohort study.Swedish National Diabetes Registry, 1 January 1998 to 31 December 2017.10 398 children and adults (...) with type1diabetes followed from diagnosis, or close thereafter, until end of 2017.Relative risk (odds ratios) for retinopathy and nephropathy for different mean levels of HbA1c.Mean age of participants was 14.7 years (43.4% female), mean duration of diabetes was 1.3 years, and mean HbA1c level was 8.0% (63.4 mmol/mol). After adjustment for age, sex, duration of diabetes, blood pressure, blood lipid levels, body mass index, and smoking, the odds ratio for mean HbA1c <6.5% (<48 mmol/mol) compared
Omega-3, omega-6, and total dietary polyunsaturated fat for prevention and treatment of type 2 diabetes mellitus: systematic review and meta-analysis of randomised controlled trials. To assess effects of increasing omega-3, omega-6, and total polyunsaturated fatty acids (PUFA) on diabetes diagnosis and glucose metabolism.Systematic review and meta-analyses.Medline, Embase, Cochrane CENTRAL, WHO International Clinical Trials Registry Platform, Clinicaltrials.gov, and trials in relevant (...) and subgrouping assessed effects of intervention type, replacement, baseline risk of diabetes and use of antidiabetes drugs, trial duration, and dose. Risk of bias was assessed with the Cochrane tool and quality of evidence with GRADE.83 randomised controlled trials (mainly assessing effects of supplementary long chain omega-3) were included; 10 were at low summary risk of bias. Long chain omega-3 had little or no effect on likelihood of diagnosis of diabetes (relative risk 1.00, 95% confidence interval 0.85
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
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
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
Assessment of chiropodist-podiatrist consultations for preventing foot lesions in diabetic patients with a grade 1 podiatric risk Assessment of chiropodist-podiatrist consultations for preventing foot lesions in diabetic patients with a grade 1 podiatric risk - INAHTA Brief
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
PIONEER 1: Randomized Clinical Trial Comparing the Efficacy and Safety of Oral Semaglutide Monotherapy with Placebo in Patients with Type 2 Diabetes This trial compared the efficacy and safety of the first oral glucagon-like peptide 1 (GLP-1) receptor agonist, oral semaglutide, as monotherapy with placebo in patients with type 2 diabetes managed by diet and exercise alone. Two estimands addressed two efficacy-related questions: a treatment policy estimand (regardless of trial product (...) discontinuation or rescue medication use) and a trial product estimand (on trial product without rescue medication use) in all randomized patients.This was a 26-week, phase 3a, randomized, double-blind, placebo-controlled, parallel-group trial conducted in 93 sites in nine countries. Adults with type 2 diabetes insufficiently controlled with diet and exercise were randomized (1:1:1:1) to once-daily oral semaglutide 3 mg, 7 mg, 14 mg, or placebo. The primary end point was change from baseline to week 26
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
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
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
were included, investigating a glucagon-like peptide-1 receptor agonist (GLP-1RA) in five, a sodium-glucose co-transporter-2 inhibitor (SGLT-2i) in two and dipeptidyl peptidase-4 inhibitors (DPP-4i) in four. Of the 102 416 participants enrolled in the included trials, only 4601 were black (4.5%). Pooled results showed no significant difference in the incidence of MACE among diabetes medications (GLP-1RA, SGLT-2i or DPP-4i) and placebo in black patients with type 2 diabetes (relative risk [RR] [95 (...) Do GLP-1RAs and SGLT-2is reduce cardiovascular events in black patients with type 2 diabetes? A systematic review and meta-analysis While recent cardiovascular safety trials (CVST) concerning newer diabetes medications included mostly white participants, results are being generalized to all races in recent guidelines. This raises a controversial question regarding the appropriateness of applying CVST data to black patients with type 2 diabetes.We searched for randomized trials comparing