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Type 1 Diabetes Mellitus

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21. Dapagliflozin (type 2 diabetes mellitus) - Addendum to Commission A19-53

Dapagliflozin (type 2 diabetes mellitus) - Addendum to Commission A19-53 1 Translation of addendum A19-92 Dapagliflozin (Diabetes mellitus Typ 2) – Addendum zum Auftrag A19-53 (Version 1.0; Status: 29 November 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Addendum 29 November 2019 1.0 Commission: A19-92 Version: Status: IQWiG Reports – Commission (...) No. A19-92 Dapagliflozin (type 2 diabetes mellitus) – Addendum to Commission A19-53 1 Addendum A19-92 Version 1.0 Dapagliflozin – Addendum to Commission A19-53 29 November 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Dapagliflozin (type 2 diabetes mellitus) – Addendum to Commission A19-53 Commissioning agency Federal Joint Committee Commission awarded on 12 November 2019 Internal Commission

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

22. Dapagliflozin/metformin (type 2 diabetes mellitus) - Addendum to Commission A19-52

Dapagliflozin/metformin (type 2 diabetes mellitus) - Addendum to Commission A19-52 1 Translation of addendum A19-93 Dapagliflozin/Metformin (Diabetes mellitus Typ 2) – Addendum zum Auftrag A19-52 (Version 1.0; Status: 29 November 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Addendum 29 November 2019 1.0 Commission: A19-93 Version: Status: IQWiG Reports (...) – Commission No. A19-93 Dapagliflozin/metformin (type 2 diabetes mellitus) – Addendum to Commission A19-52 1 Addendum A19-93 Version 1.0 Dapagliflozin/metformin – Addendum to Commission A19-52 29 November 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Dapagliflozin/metformin (type 2 diabetes mellitus) – Addendum to Commission A19-52 Commissioning agency Federal Joint Committee Commission awarded

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

23. Dapagliflozin/metformin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V

Dapagliflozin/metformin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Dapagliflozin/Metformin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (neue wissenschaftliche Erkenntnisse) (Version 1.0; Status: 27 September 2019). Please note: This translation 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. A19-52 Dapagliflozin/metformin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 (new scientific findings) Extract of dossier assessment A19-52 Version 1.0 Dapagliflozin/metformin (type 2 diabetes mellitus) 27 September 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dapagliflozin/metformin (type

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

24. Empagliflozin/linagliptin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V

Empagliflozin/linagliptin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Empagliflozin/Linagliptin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 August 2019). Please note: This translation 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. A19-49 Empagliflozin/linagliptin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-49 Version 1.0 Empagliflozin/linagliptin (type 2 diabetes mellitus) 29 August 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Empagliflozin/linagliptin (type 2 diabetes mellitus) – Benefit assessment according

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

25. Sotagliflozin with insulin for treating type 1 diabetes

rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 5 of 212 2 Information about sotagliflozin Information about sotagliflozin Marketing Marketing authorisation authorisation indication indication Sotagliflozin is indicated 'as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a body mass index (BMI) 27 kg/m 2 or more, who have failed to achieve adequate glycaemic control despite (...) optimal insulin therapy' . Sotagliflozin should not be started in people with type 1 diabetes with a low insulin need. It should not be started in people with a glomerular filtration rate of less than 60 ml/min and should be stopped at a glomerular filtration rate persistently below 45 ml/min. Sotagliflozin should be initiated and supervised by a physician experienced in the management of type 1 diabetes mellitus. During treatment with sotagliflozin, insulin therapy should be continuously optimised

2020 National Institute for Health and Clinical Excellence - Technology Appraisals

26. Sotagliflozin tablets as an adjuct therapy to insulin for Type 1 diabetes mellitus

Sotagliflozin tablets as an adjuct therapy to insulin for Type 1 diabetes mellitus Sotagliflozin tablets as an adjuct therapy to insulin for Type 1 diabetes mellitus | Innovation Observatory toggle menu Menu Search View All Filter by Speciality Filter by Year Filter by Category This search function provides links to outputs produced by NIHR Innovation Observatory. These are briefing notes or reports on new or repurposed technologies. This search will not return all technologies currently (...) in development as these outputs are produced as required for our stakeholders. > > > Sotagliflozin tablets as an adjuct therapy to insulin for Type 1 diabetes mellitus Sotagliflozin tablets as an adjuct therapy to insulin for Type 1 diabetes mellitus September 2017 Sotagliflozin is a drug being developed to lower blood sugar levels in type 1 diabetes by increasing the amount of sugars excreted in the urine. It is taken once a day tablet in conjunction with insulin to prevent large rises and falls in blood

2017 NIHR Innovation Observatory

27. A Practical Approach to the Management of Continuous Glucose Monitoring (CGM) / Real-Time Flash Glucose Scanning (FGS) in Type 1 Diabetes Mellitus in Children and Young People Under 18 years

A Practical Approach to the Management of Continuous Glucose Monitoring (CGM) / Real-Time Flash Glucose Scanning (FGS) in Type 1 Diabetes Mellitus in Children and Young People Under 18 years 1 Version 3, Oct 2018 Review 2021 Authors: ACDC Guideline Development Group N Wright, SM Ng, JC Agwu, P Adolfsson, J Drew, J Pemberton, M Kershaw, S Bissell, C Moudiotis, F Regan, C Gardner, A Astle, A Adams, G Adams, P Manning, A Timmis, A Soni, E Williams ssociation of Children ’s Diabetes Clinicians (...) FOR STAFF Healthcare professionals involved in care of children and young people with Type 1 Diabetes Mellitus PATIENTS Children and young people with diabetes mellitus This guideline is intended for use in managing continuous glucose monitoring (CGM) or real-time flash glucose scanning (FGS) for all children and young people under 18 years with Type 1 diabetes mellitus. Table of Contents Introduction 2 Overview of Pertinent NICE guidance 3 Devices Available for CGM and FGS 6 Section 1: Evidence

2018 British Society for Paediatric Endocrinology and Diabetes

28. Insulin degludec + liraglutide (Xultophy) - Diabetes mellitus, Type 2

Insulin degludec + liraglutide (Xultophy) - Diabetes mellitus, Type 2 insulin degludec + liraglutide | CADTH.ca Find the information you need insulin degludec + liraglutide insulin degludec + liraglutide Last Updated: October 3, 2019 Result type: Reports Project Number: SR0599-000 Product Line: Generic Name: insulin degludec + liraglutide Brand Name: Xultophy Manufacturer: Novo Nordisk Canada Inc. Indications: Diabetes mellitus, Type 2 Manufacturer Requested Reimbursement Criteria 1 (...) : To be reimbursed as an adjunct to lifestyle modifications to improve glycemic control in adults with type 2 diabetes mellitus when oral glucose-lowering medications combined with basal insulin, or basal insulin alone do not provide adequate glycemic control. Submission Type: New Combination Project Status: Active Biosimilar: No 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

2019 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

29. 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

30. Insulin glargine/lixisenatide (Suliqua) - for the treatment of adults with type 2 diabetes mellitus

Insulin glargine/lixisenatide (Suliqua) - for the treatment of adults with type 2 diabetes mellitus 1 Published 13 April 2020 1 SMC2235 insulin glargine plus lixisenatide (Suliqua®), 100 units/mL plus 50 microgram/mL and 100 units/mL plus 33 micrograms/mL solution for subcutaneous injection in pre-filled pens Aventis Pharma Limited, trading as Sanofi 06 March 2020 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug (...) insulin. SMC restriction: for use in patients who are uncontrolled on basal insulin (glycosylated haemoglobin [HbA1c] > 7.5% [59mmol/mol]) and for whom a GLP-1 receptor agonist is appropriate as an add-on intensification therapy to basal insulin analogues. Insulin glargine/lixisenatide improved glycaemic control compared with insulin glargine alone in adults with inadequately controlled type 2 diabetes mellitus. Chairman Scottish Medicines Consortium www.scottishmedicines.org.uk 2 Indication

2020 Scottish Medicines Consortium

31. Clinical Management of Stable Coronary Artery Disease in Patients With Type 2 Diabetes Mellitus: A Scientific Statement From the American Heart Association

disease; DPP4, dipeptidyl peptidase 4; GLP-1, glucagon-like peptide-1; HDL-C, high-density lipoprotein cholesterol; LDL, low-density lipoprotein; LV, left ventricular; MACE, major adverse cardiovascular event; MI, myocardial infarction; PCSK9, proprotein convertase subtilisin/kexin type 9; SGLT2, sodium-glucose cotransporter 2; and T2DM, type 2 diabetes mellitus. Aspirin and Clopidogrel In the setting of this platelet-centric thrombogenic milieu, medical management with antiplatelet therapies has been (...) . However, because of the higher underlying risk of patients with T2DM, statins often result in greater absolute risk reduction. Among the 20 536 adults in the HPS (Heart Protection Study), which tested once-daily 40 mg simvastatin (versus placebo) in a mix of primary and secondary prevention patients, 5963 participants had diabetes mellitus (615 with type 1 diabetes mellitus), and 3982 had both diabetes mellitus and CAD. The diabetes mellitus subanalysis showed that simvastatin was associated with a 22

2020 American Heart Association

32. 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

33. 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

34. 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)

35. 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)

36. 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

37. 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

38. 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

39. 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

40. 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

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