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Type 1 Diabetes Mellitus

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41. Management of Type 2 Diabetes Mellitus

= generally should not be performed. Level of evidence supporting a diagnostic method or an intervention: A=randomized controlled trials; B=controlled trials, no randomization; C=observational trials; D=opinion of expert panel. 2 UMHS Management of Type 2 Diabetes Mellitus June, 2017 Table 1. Diagnosis of Diabetes: Diagnostic Tests and Glucose Values Diagnostic Test Normal Pre-diabetes Diabetes Hemoglobin A1c (A1c) a 30 mg/gm, check UA to rule out asymptomatic UTI. • Repeat spot urine ratio twice within 6 (...) for patients with type 2 diabetes. However, their use is rarely successful in patients with type 1 diabetes. 21 UMHS Management of Type 2 Diabetes Mellitus June, 2017 Symlin. Symlin is not a type of insulin but an amylinomimetic agent approved as adjunct therapy in patients with type 1 and type 2 diabetes who use mealtime insulin but who are not achieving optimal control. Symlin is used at mealtimes to augment the effects of insulin on glycemic control. This can cause hypoglycemia which can occur within 3

2020 University of Michigan Health System

42. Children and adolescents with type 1 and type 2 diabetes mellitus in the Pediatric Diabetes Consortium Registries: comparing clinical characteristics and glycaemic control. (Abstract)

Children and adolescents with type 1 and type 2 diabetes mellitus in the Pediatric Diabetes Consortium Registries: comparing clinical characteristics and glycaemic control. To compare the characteristics of children and adolescents with type 1 vs. type 2 diabetes in the Pediatric Diabetes Consortium (PDC) registries.Participants were 10 to < 21 years of age at diagnosis; there were 484 with type 1 diabetes and 1236 with type 2 diabetes.Children and adolescents with type 2 diabetes were more (...) likely to be female, overweight/obese, and from low-income, minority ethnic families. Children and adolescents with type 1 diabetes were more likely to present with diabetic ketoacidosis and have higher mean HbA1c levels at diagnosis. More than 70% in both cohorts achieved target HbA1c levels < 58 mmol/mol (< 7.5%) within 6 months, but fewer participants with type 1 than type 2 diabetes were able to maintain target HbA1c levels after 6 months consistently throughout 3 years post diagnosis. Of the 401

2020 Diabetic Medicine

43. Sodium-glucose cotransporter (SGLT) 2 inhibitors for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Full Text available with Trip Pro

Sodium-glucose cotransporter (SGLT) 2 inhibitors for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Sodium-glucose cotransporter (SGLT) 2 inhibitors were recently approved as glucose-lowering interventions in people with type 2 diabetes mellitus (T2DM). Potential beneficial or harmful effects of SGLT 2 inhibitors in people at risk for the development of T2DM are unknown.To assess the effects (...) for the development of type 2 diabetes and a follow-up of 24 to 26 weeks. Both trials will mainly report on surrogate outcome measures with some data on adverse effects and health-related quality of life.Due to lack of data it is not possible to conclude whether SGLT 2 inhibitors prevent or delay the diagnosis of T2DM and its associated complications.

2016 Cochrane

44. Insulin glargine/lixisenatide (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V

Insulin glargine/lixisenatide (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Insulin glargin/Lixisenatid (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 May 2018). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text (...) is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A18-16 Insulin glargine/lixisenatide (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-16 Version 1.0 Insulin glargine/lixisenatide (type 2 diabetes mellitus) 20 May 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Insulin glargine/lixisenatide (type

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

45. Ertugliflozin/sitagliptin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V

Ertugliflozin/sitagliptin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Ertugliflozin/Sitagliptin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Version 1.1; Status: 6 September 2018). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text (...) is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A18-31 Ertugliflozin/sitagliptin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-31 Version 1.1 Ertugliflozin/sitagliptin (type 2 diabetes mellitus) 6 September 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ertugliflozin/sitagliptin (type 2

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

46. Altered superoxide dismutase-1 activity and intercellular adhesion molecule 1 (ICAM-1) levels in patients with type 2 diabetes mellitus. Full Text available with Trip Pro

Altered superoxide dismutase-1 activity and intercellular adhesion molecule 1 (ICAM-1) levels in patients with type 2 diabetes mellitus. Inflammation and oxidative stress are linked to type 2 diabetes mellitus (T2DM). In this work, we analyzed patients' blood markers of antioxidant capacity, oxidative stress and inflammation in individuals with T2DM, in pre-diabetes state (pre-DM) and controls without diabetes. Patients were divided into three groups, according to glycated hemoglobin A1c (HbA1c (...) ): <7%, 7-9%, and >9%. Superoxide dismutase (SOD) and glutathione peroxidase (GPX) activities, total thiols, nitric oxide (•NO), tumor necrosis factor alpha (TNF-α) and intercellular adhesion molecule 1 (ICAM-1) levels of the individuals were measured. Plasma SOD activity was higher in T2DM subjects compared to the controls. While total thiols levels were lower in T2DM groups when compared to pre-DM, the values remained unchanged when compared to controls. ICAM-1 levels of T2DM groups were lower

2019 PLoS ONE

47. Flash Glucose Monitoring System for People with Type 1 or Type 2 Diabetes

Flash Glucose Monitoring System for People with Type 1 or Type 2 Diabetes Published December 2019 Volume 19, Number 8 ONTARIO HEALTH TECHNOLOGY ASSESSMENT SERIES Flash Glucose Monitoring System for People with Type 1 or Type 2 Diabetes: A Health Technology Assessment KEY MESSAGES What Is This Health Technology Assessment About? Diabetes is a health condition in which the pancreas cannot produce any insulin, the pancreas cannot produce enough insulin, or the body cannot properly use the insulin (...) the pancreas does produce. Insulin is a hormone that helps the body’s cells use glucose (a type of sugar) for energy. Without insulin, glucose builds up in the blood and can cause serious damage to the body. Type 1 diabetes occurs when the pancreas produces little or no insulin. Type 2 diabetes occurs when the pancreas does not produce enough insulin or when the body does not respond to insulin properly. People with diabetes have a greater risk of being sent to hospital with life-threating conditions

2019 Health Quality Ontario

48. The Effect of Sleep Hygiene Education on Sleep Quality in Children with Type 1 Diabetes Mellitus: A Preliminary Study. (Abstract)

The Effect of Sleep Hygiene Education on Sleep Quality in Children with Type 1 Diabetes Mellitus: A Preliminary Study. To identify the effect of sleep hygiene education on sleep quality in children with Type 1 Diabetes Mellitus (T1DM), a quasi-experiment with control group and pretest-posttest design was conducted. Samples of 46 children with T1DM in IKADAR were assigned into intervention (n = 23) and control (n = 23). The intervention group received sleep hygiene education for 10 minutes via

2019 Comprehensive child and adolescent nursing Controlled trial quality: uncertain

49. Psychological interventions for diabetes-related distress in adults with type 2 diabetes mellitus. Full Text available with Trip Pro

Psychological interventions for diabetes-related distress in adults with type 2 diabetes mellitus. Many adults with type 2 diabetes mellitus (T2DM) experience a psychosocial burden and mental health problems associated with the disease. Diabetes-related distress (DRD) has distinct effects on self-care behaviours and disease control. Improving DRD in adults with T2DM could enhance psychological well-being, health-related quality of life, self-care abilities and disease control, also reducing (...) depressive symptoms.To assess the effects of psychological interventions for diabetes-related distress in adults with T2DM.We searched the Cochrane Library, MEDLINE, Embase, PsycINFO, CINAHL, BASE, WHO ICTRP Search Portal and ClinicalTrials.gov. The date of the last search was December 2014 for BASE and 21 September 2016 for all other databases.We included randomised controlled trials (RCTs) on the effects of psychological interventions for DRD in adults (18 years and older) with T2DM. We included trials

2017 Cochrane

50. Diabetes Stewardship – Pharmaceutical care of adolescents with type 1 diabetes mellitus provided by community pharmacists. (Abstract)

Diabetes Stewardship – Pharmaceutical care of adolescents with type 1 diabetes mellitus provided by community pharmacists. Diabetes mellitus Type 1 is one of the most common diseases in childhood. Severe, secondary diseases like hypertension or blindness are results of micro- and macrovascular complications caused by insufficient glycaemic control. Especially adolescent patients with type 1 diabetes have a lower adherence rate. The DIADEMA trial proved that community pharmacist (...) in collaboration with diabetologists and diabetes advisors can have a positive impact on the therapy of adolescents with type 1 diabetes. This article highlights and explains which components of the pharmacist intervention caused the preferable adjustments and improved the insulin therapy of the patients.

2018 Medizinische Monatsschrift fur Pharmazeuten Controlled trial quality: uncertain

51. Pharmacotherapy Management of Type 2 Diabetes Mellitus: Guidelines

Pharmacotherapy Management of Type 2 Diabetes Mellitus: Guidelines Pharmacotherapy Management of Type 2 Diabetes Mellitus: Guidelines | CADTH.ca Find the information you need Pharmacotherapy Management of Type 2 Diabetes Mellitus: Guidelines Pharmacotherapy Management of Type 2 Diabetes Mellitus: Guidelines Last updated: December 12, 2018 Project Number: RA0993-000 Product Line: Research Type: Drug Report Type: Reference List Result type: Report Question What are the evidence-based guidelines (...) regarding the optimal pharmacological management of Type 2 Diabetes Mellitus? Key Message Thirteen evidence-based guidelines were identified regarding the optimal pharmacological management of Type 2 Diabetes Mellitus. Files Rapid Response Reference List Published : December 12, 2018 Related Content Follow us: © 2019 Canadian Agency for Drugs and Technologies in Health Get our newsletter:

2018 Canadian Agency for Drugs and Technologies in Health - Rapid Review

52. Ozempic - semaglutide - Diabetes mellitus, type 2

Ozempic - semaglutide - Diabetes mellitus, type 2 semaglutide | CADTH.ca Find the information you need semaglutide semaglutide Last Updated: June 18, 2019 Result type: Reports Project Number: SR0594-000 Product Line: Generic Name: semaglutide Brand Name: Ozempic Manufacturer: Novo Nordisk Canada Inc. Indications: Diabetes mellitus, type 2 Manufacturer Requested Reimbursement Criteria 1 : For the treatment of adults patients with type 2 diabetes to improve glycemic control, in combination (...) with metformin (second line treatment) and in combination with metformin and sulfonylurea (third line treatment). Submission Type: New Project Status: Complete Biosimilar: No Date Recommendation Issued: May 15, 2019 Recommendation Type: Reimburse with clinical criteria and/or conditions Fee Schedule: Schedule A The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation

2018 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

53. Soliqua - lixisenatide + insulin glargine - Diabetes mellitus, Type 2

Soliqua - lixisenatide + insulin glargine - Diabetes mellitus, Type 2 lixisenatide + insulin glargine | CADTH.ca Find the information you need lixisenatide + insulin glargine lixisenatide + insulin glargine Last Updated: January 3, 2019 Result type: Reports Project Number: SR0564-000 Product Line: Generic Name: lixisenatide + insulin glargine Brand Name: Soliqua Manufacturer: sanofi-aventis Canada Inc. Indications: Diabetes mellitus, Type 2 Manufacturer Requested Reimbursement Criteria 1 (...) : Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when oral glucose-lowering medicinal products combined with basal insulin, or basal insulin alone do not provide adequate glycaemic control. Submission Type: New Combination Project Status: Complete Biosimilar: No Companion Diagnostics: No Date Recommendation Issued: December 24, 2018 Recommendation Type: Reimburse with clinical criteria and/or conditions Fee Schedule: Schedule

2018 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

54. Steglatro - ertugliflozin - Diabetes mellitus, Type 2

Steglatro - ertugliflozin - Diabetes mellitus, Type 2 ertugliflozin | CADTH.ca Find the information you need ertugliflozin ertugliflozin Last Updated: January 25, 2019 Result type: Reports Project Number: SR0565-000 Product Line: Generic Name: ertugliflozin Brand Name: Steglatro Manufacturer: Merck Canada Inc. Indications: Diabetes mellitus, Type 2 Manufacturer Requested Reimbursement Criteria 1 : As monotherapy for patients who have inadequate glycemic control and for whom metformin (...) or a sulfonylurea is inappropriate due to contraindications or intolerance. Add-on to metformin for patients who have inadequate glycemic control on metformin and have a contraindication or intolerance to a sulfonylurea. Submission Type: New Project Status: Complete Biosimilar: No Companion Diagnostics: No Date Recommendation Issued: January 23, 2019 Recommendation Type: Do not reimburse Fee Schedule: Schedule A The requested reimbursement criteria are provided by the applicant and do not necessarily reflect

2018 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

55. Segluromet - ertugliflozin and metformin hydrochloride - Diabetes mellitus, Type 2

Segluromet - ertugliflozin and metformin hydrochloride - Diabetes mellitus, Type 2 ertugliflozin and metformin | CADTH.ca Find the information you need ertugliflozin and metformin ertugliflozin and metformin Last Updated: January 25, 2019 Result type: Reports Project Number: SR0566-000 Product Line: Generic Name: ertugliflozin and metformin hydrochloride Brand Name: Segluromet Manufacturer: Merck Canada Inc. Indications: Diabetes mellitus, Type 2 Manufacturer Requested Reimbursement Criteria 1 (...) : Added on to metformin for patients who have inadequate glycemic control on metformin and have a contraindication or intolerance to a sulfonylurea, or To replace the individual components of ertugliflozin and metformin for those patients who are on both therapies Submission Type: New Combination Project Status: Complete Biosimilar: No Companion Diagnostics: No Date Recommendation Issued: January 23, 2019 Recommendation Type: Do not reimburse Fee Schedule: Schedule C The requested reimbursement

2018 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

56. A community-based primary prevention programme for type 2 diabetes mellitus integrating identification and lifestyle intervention for prevention: a cluster randomised controlled trial Full Text available with Trip Pro

A community-based primary prevention programme for type 2 diabetes mellitus integrating identification and lifestyle intervention for prevention: a cluster randomised controlled trial A community-based primary prevention programme for type 2 diabetes mellitus integrating identification and lifestyle intervention for prevention: a cluster randomised controlled trial Journals Library An error occurred retrieving content to display, please try again. >> >> >> Page Not Found Page not found (404 (...) Realf 4 , Timothy Skinner 6 , Bernie Stribling 4 , Jacqui Troughton 4 , Thomas Yates 1 , Kamlesh Khunti 1 1 Diabetes Research Centre, University of Leicester, Leicester, UK 2 Department of Health Sciences, University of Leicester, Leicester, UK 3 Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK 4 Leicester Diabetes Centre, University Hospitals of Leicester, Leicester, UK 5 Patient and Public Involvement Group, Leicester Diabetes Centre

2017 NIHR HTA programme

57. Alogliptin (Nesina) - type 2 diabetes mellitus

Alogliptin (Nesina) - type 2 diabetes mellitus Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs written for approved after September 1, 2012 (...) Activity/submission type, control number Date submitted Decision and date Summary of activities Summary Basis of Decision (SBD) for Date SBD issued: The following information relates to the new drug submission for . Drug Identification Number (DIN): 1 What was approved? 2 Why was approved? 3 What steps led to the approval of ? Submission Milestones: Submission Milestone Date 4 What follow-up measures will the company take? 5 What post-authorization activity has taken place for ? 6 What other

2018 Health Canada - Drug and Health Product Register

58. Ertugliflozin l-pyroglutamic acid (Steglatro) - Diabetes Mellitus, Type 2

the Fridericia formula R AC Accumulation ratio RH relative humidity RQ (Environmental) Risk Quotient SBP systolic blood pressure SGLT1 sodium-glucose co-transporter 1 SGLT2 sodium-glucose co-transporter 2 SmPC summary of product characteristics TAMC total aerobic microbial count TYMC total combined yeasts/moulds count T2DM type 2 diabetes mellitus t max time to C max UGE urinary glucose excretion UGT uridine 5’-diphospho-glucuronosyltransferase ULN upper limit of normal UV ultraviolet UV-Vis ultraviolet (...) Ertugliflozin is an oral, selective inhibitor of sodium glucose co-transporter-2 (SGLT2) which inhibits renal glucose reabsorption and results in urinary glucose excretion (UGE) and reductions in plasma glucose and haemoglobin A1c (A1C) in patients with type 2 diabetes mellitus (T2DM). It possesses a high selectivity for SGLT2 versus SGLT1 and other glucose transporters (GLUT1-4). Ertugliflozin is a new chemical entity with a chemical name of (1S,2S,3S,4R,5S)-5-[4-Chloro-3- (4- ethoxybenzyl)phenyl]-1

2018 European Medicines Agency - EPARs

59. Ertugliflozin l-pyroglutamic acid / sitagliptin phosphate monohydrate (Steglujan) - Diabetes Mellitus, Type 2

in the circulation in a glucose-dependent manner. Type of Application and aspects on development The development program has in all essentials followed the EMA Guideline “Clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus” (CHMP/EWP/1080/00 Rev. 1), the EMA guideline “Clinical development of fixed combination medicinal products” (CHMP/EWP/240/95 Rev. 1) and the scientific advice given on the following topics: Design of non-clinical and clinical phase 3 development (...) Ertugliflozin l-pyroglutamic acid / sitagliptin phosphate monohydrate (Steglujan) - Diabetes Mellitus, Type 2 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 25 January 2018 EMA/86941/2018 Committee for Medicinal Products

2018 European Medicines Agency - EPARs

60. Ertugliflozin l-pyroglutamic acid / metformin hydrochloride (Segluromet) - Diabetes Mellitus, Type 2

analysis plan SGLT1 sodium-glucose co-transporter 1 SGLT2 sodium-glucose co-transporter 2 SmPC summary of product characteristics SMQ Standard MedDRA Query SOC System organ class T2DM type 2 diabetes mellitus TAMC total aerobic microbial count Tmax time to first occurrence of maximum observed concentration TYMC total combined yeasts/moulds count UGE urinary glucose excretion ULN upper limit of normal US United States USPI United States Prescribing Information UTI urinary tract infection UV ultraviolet (...) , decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Metformin is approved for use in the US, Europe, and other countries and has an established safety and tolerability profile. Type of Application and aspects on development The development program has in all essentials followed the EMA Guideline “Clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus” (CHMP/EWP/1080/00 Rev. 1

2018 European Medicines Agency - EPARs

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