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Type 1 Diabetes Mellitus

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1. Dipeptidyl-peptidase (DPP)-4 inhibitors and glucagon-like peptide (GLP)-1 analogues for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk for the development of type 2 diabetes mellitus. (Full text)

Dipeptidyl-peptidase (DPP)-4 inhibitors and glucagon-like peptide (GLP)-1 analogues for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk for the development of type 2 diabetes mellitus. The projected rise in the incidence of type 2 diabetes mellitus (T2DM) could develop into a substantial health problem worldwide. Whether dipeptidyl-peptidase (DPP)-4 inhibitors or glucagon-like peptide (GLP)-1 analogues are able to prevent or delay (...) T2DM and its associated complications in people at risk for the development of T2DM is unknown.To assess the effects of DPP-4 inhibitors and GLP-1 analogues on the prevention or delay of T2DM and its associated complications in people with impaired glucose tolerance, impaired fasting blood glucose, moderately elevated glycosylated haemoglobin A1c (HbA1c) or any combination of these.We searched the Cochrane Central Register of Controlled Trials; MEDLINE; PubMed; Embase; ClinicalTrials.gov; the World

2017 Cochrane PubMed abstract

2. Dapagliflozin (type 1 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V

Dapagliflozin (type 1 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 (Diabetes mellitus Typ 1) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 July 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. A19-37 Dapagliflozin (type 1 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-37 Version 1.0 Dapagliflozin (type 1 diabetes mellitus) 30 July 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 1 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

3. Dapagliflozin (type 1 diabetes mellitus) - Addendum to Commission A19-37

Dapagliflozin (type 1 diabetes mellitus) - Addendum to Commission A19-37 1 Translation of addendum A19-79 Dapagliflozin (Diabetes Mellitus Typ 1) – Addendum zum Auftrag A19-37 (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. Addendum 27 September 2019 1.0 Commission: A19-79 Version: Status: IQWiG Reports – Commission (...) No. A19-79 Dapagliflozin (type 1 diabetes mellitus) – Addendum to Commission A19-37 1 Addendum A19-79 Version 1.0 Dapagliflozin – Addendum to Commission A19-37 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 (type 1 diabetes mellitus) – Addendum to Commission A19-37 Commissioning agency: Federal Joint Committee Commission awarded on: 9 September 2019 Internal

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

4. Alpha-glucosidase inhibitors for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk of developing type 2 diabetes mellitus. (Full text)

Alpha-glucosidase inhibitors for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk of developing type 2 diabetes mellitus. Alpha-glucosidase inhibitors (AGI) reduce blood glucose levels and may thus prevent or delay type 2 diabetes mellitus (T2DM) and its associated complications in people at risk of developing of T2DM.To assess the effects of AGI in people with impaired glucose tolerance (IGT), impaired fasting blood glucose (IFG (...) model with assessment of risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. We assessed the overall quality of the evidence by using the GRADE instrument.For this update of the Cochrane Review (first published 2006, Issue 4) we included 10 RCTs (11,814 participants), eight investigating acarbose and two investigating voglibose, that included people with IGT or people "at increased risk for diabetes

2018 Cochrane PubMed abstract

5. Minimed 670g - for the management of type 1 diabetes mellitus

Minimed 670g - for the management of type 1 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) Summary basis of decision (SBD) documents provide information related to the original authorization of a product. The for the is located below. Updated: The following (...) table describes post-licensing activity for the . For more information on the type of information found in PLATs, please refer to the For additional information about the medical device application process, refer to the . Licence Number: Post-Licensing Activity Table (PLAT) Activity/Application Type, Application Number Date Submitted Decision and Date Summary of Activities 1 What was approved? Application Milestones: Application Milestone Date For additional information about the medical device

2019 Health Canada - Drug and Health Product Register

6. Diagnostic Accuracy of Neutrophil Gelatinase-Associated Lipocalin for Predicting Early Diabetic Nephropathy in Patients with Type 1 and Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis. (Abstract)

Diagnostic Accuracy of Neutrophil Gelatinase-Associated Lipocalin for Predicting Early Diabetic Nephropathy in Patients with Type 1 and Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis. Currently, there is a lack of prediction markers for diabetic nephropathy (DN) in patients with type 1 and type 2 diabetes mellitus (T1DM/T2DM). The aim of this systematic review and meta-analysis was to evaluate the value of a promising biomarker, neutrophil gelatinase-associated lipocalin (NGAL (...) ), in both serum and urine for the diagnosis of early DN in T1DM and T2DM patients with different stages of albuminuria.A comprehensive search was performed on PubMed by 2 reviewers until September 2018. Studies in which (a) the degree of DN was determined according to the urinary albumin/creatinine ratio and (b) NGAL was measured in healthy individuals and in diabetes patients with DN were included in the meta-analysis. For each study, a 2 × 2 contingency table was formulated. Sensitivity, specificity

2020 The journal of applied laboratory medicine

8. Diet, physical activity or both for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk of developing type 2 diabetes mellitus. (Full text)

Diet, physical activity or both for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk of developing type 2 diabetes mellitus. The projected rise in the incidence of type 2 diabetes mellitus (T2DM) could develop into a substantial health problem worldwide. Whether diet, physical activity or both can prevent or delay T2DM and its associated complications in at-risk people is unknown.To assess the effects of diet, physical activity or both

2017 Cochrane PubMed abstract

9. Dapagliflozin (Forxiga) - type 1 diabetes mellitus

Dapagliflozin (Forxiga) - type 1 diabetes 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 type 1 diabetes 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 type 1 diabetes. Chairman Scottish Medicines Consortium www.scottishmedicines.org.uk 2 Indication

2019 Scottish Medicines Consortium

10. Sotagliflozin for adult patients with Type 1 Diabetes Mellitus who have inadequate blood glucose control using insulin or insulin analogues

Sotagliflozin for adult patients with Type 1 Diabetes Mellitus who have inadequate blood glucose control using insulin or insulin analogues Dec2015 © EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 1 EUnetHTA Joint Action 3 WP4 Version 1.3, 7 th June 2019 Relative effectiveness assessment of pharmaceutical technologies SOTAGLIFLOZIN IS 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 , WHO HAVE FAILED TO ACHIEVE ADEQUATE GLYCAEMIC CONTROL DESPITE OPTIMAL INSULIN THERAPY Project ID: PTJA04 PTJA04 - 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 , who have failed to achieve adequate glycaemic control despite optimal insulin therapy June 2019 EUnetHTA Joint Action 3 WP4 2 DOCUMENT HISTORY AND CONTRIBUTORS Version Date Description V1.0 16

2019 EUnetHTA

11. Diabetes mellitus type 1 and type 2: insulin glargine biosimilar (Abasaglar)

Diabetes mellitus type 1 and type 2: insulin glargine biosimilar (Abasaglar) Diabetes mellitus type 1 and type 2: insulin Diabetes mellitus type 1 and type 2: insulin glargine biosimilar (Abasaglar) glargine biosimilar (Abasaglar) Evidence summary Published: 2 December 2015 nice.org.uk/guidance/esnm64 pathways K Ke ey points from the e y points from the evidence vidence The content of this evidence summary was up-to-date in December 2015. See summaries of product characteristics (SPCs), British (...) as for Lantus and lists hypoglycaemia as a very common adverse reaction. Diabetes mellitus type 1 and type 2: insulin glargine biosimilar (Abasaglar) (ESNM64) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 29P Patient factors atient factors Abasaglar is given once daily by subcutaneous injection, and is available as 100 units/ml in cartridges or as a pre-filled pen. Across the 2 RCTs similar numbers of people withdrew

2015 National Institute for Health and Clinical Excellence - Advice

12. Adult Type 1 diabetes mellitus

Adult Type 1 diabetes mellitus Adult type 1 diabetes mellitus National Clinical Guideline No. 17 National Patient Safety Office Oifig Náisiúnta um Shábháilteacht Othar June 2018This National Clinical Guideline for adults with type 1 diabetes has been developed by the Guideline Development Group, supported by the HSE National Clinical Programme for Diabetes. Part of the process of developing this guideline involved contextualising (for Ireland) the National Institute for Health and Care (...) guidance © NICE (2015) Type 1 diabetes in adults: diagnosis and management. Available from https://www.nice.org.uk/guidance/ng17 All rights reserved. Subject to Notice of rights . NICE guidance is prepared for the National Health Service in England. It is subject to regular review and updating and may be withdrawn. NICE accepts no responsibility for the use of its content in this publication. Citation text Department of Health (2018) Adult type 1 diabetes mellitus (NCEC National Clinical Guideline

2018 National Clinical Guidelines (Ireland)

13. National Clinical Guideline on Adult type 1 diabetes mellitus

National Clinical Guideline on Adult type 1 diabetes mellitus Adult type 1 diabetes mellitus National Clinical Guideline No. 17 National Patient Safety Office Oifig Náisiúnta um Shábháilteacht Othar June 2018This National Clinical Guideline for adults with type 1 diabetes has been developed by the Guideline Development Group, supported by the HSE National Clinical Programme for Diabetes. Part of the process of developing this guideline involved contextualising (for Ireland) the National (...) This guideline draws on NICE guidance © NICE (2015) Type 1 diabetes in adults: diagnosis and management. Available from https://www.nice.org.uk/guidance/ng17 All rights reserved. Subject to Notice of rights . NICE guidance is prepared for the National Health Service in England. It is subject to regular review and updating and may be withdrawn. NICE accepts no responsibility for the use of its content in this publication. Citation text Department of Health (2018) Adult type 1 diabetes mellitus (NCEC National

2018 HIQA Guidelines

14. The Management of Insulin Administration and Blood Glucose Monitoring in Children with Type 1 Diabetes Mellitus: Guidelines

The Management of Insulin Administration and Blood Glucose Monitoring in Children with Type 1 Diabetes Mellitus: Guidelines The Management of Insulin Administration and Blood Glucose Monitoring in Children with Type 1 Diabetes Mellitus: Guidelines | CADTH.ca Find the information you need The Management of Insulin Administration and Blood Glucose Monitoring in Children with Type 1 Diabetes Mellitus: Guidelines The Management of Insulin Administration and Blood Glucose Monitoring in Children (...) with Type 1 Diabetes Mellitus: Guidelines Published on: May 24, 2017 Project Number: RB1094-000 Product Line: Research Type: Devices and Systems Report Type: Summary of Abstracts Result type: Report Question What are the evidence-based guidelines regarding the management of insulin administration in children with type 1 diabetes mellitus? What are the evidence-based guidelines regarding the monitoring of blood glucose in children with type 1 diabetes mellitus? Key Message Three evidence-based guidelines

2017 Canadian Agency for Drugs and Technologies in Health - Rapid Review

15. Insulin glargine biosimilar (Basaglar) for the treatment of type 1 and type 2 diabetes mellitus

Insulin glargine biosimilar (Basaglar) for the treatment of type 1 and type 2 diabetes mellitus '); } else { document.write(' '); } ACE | Insulin glargine biosimilar (Basaglar) for the treatment of type 1 and type 2 diabetes mellitus Search > > Insulin glargine biosimilar (Basaglar) for the treatment of type 1 and type 2 diabetes mellitus - Insulin glargine biosimilar (Basaglar) for the treatment of type 1 and type 2 diabetes mellitus Published on 16 October 2017 Guidance Recommendation (...) The Ministry of Health's Drug Advisory Committee has recommended: Insulin glargine biosimilar (Basaglar) injection 100 units/ml cartridge for the treatment of type 1 and type 2 diabetes mellitus in adults, adolescents and children aged 6 years or above, where treatment with insulin is required. Subsidy status Insulin glargine biosimilar (Basaglar) injection 100 units/ml cartridge is recommended for inclusion on the Standard Drug List (SDL) for the abovementioned indication. The manufacturer has offered

2017 Appropriate Care Guides, Agency for Care Effectiveness (Singapore)

16. Management of Type 1 Diabetes Mellitus during illness in children and young people under 18 years (Sick Day Rules)

Management of Type 1 Diabetes Mellitus during illness in children and young people under 18 years (Sick Day Rules) 1 Version 4, Feb 2018 Review 2021 Authors: SM Ng, A Soni, JC Agwu, JA Edge, JH Drew, C Moudiotis, NP Wright, M Kershaw, MC Gardner, L Connellan, W Assam ssociation of Children’s Diabetes Clinicians Clinicians SETTING FOR STAFF Medical and nursing staff PATIENTS Children and young people with diabetes mellitus Contents 1. Introduction 2 2. Importance of Local ‘Sick-Day’ Rules 2 3 (...) . Ketone testing 2 4. Fluid Management 3 5. Out of hours diabetes advice 4 6. Diabetes Self Management Education 4 7. General Rules for Managing Diabetes During Illness 4 7.1. Using sick day doses on pump therapy 7 7.2. Management of infections usually associated with hypoglycaemia eg. gastroenteritis ... 7 8. References 8 9. Appendix: Patient Advice Leaflet…………………………………………………………………...10 Clinical Guideline Management of Type 1 Diabetes Mellitus during illness in children and young people under 18 years

2019 British Society for Paediatric Endocrinology and Diabetes

17. Type 1 diabetes mellitus in adults: high-strength insulin glargine 300 units/ml (Toujeo)

Type 1 diabetes mellitus in adults: high-strength insulin glargine 300 units/ml (Toujeo) T T ype 1 diabetes mellitus in adults: high-strength ype 1 diabetes mellitus in adults: high-strength insulin glargine 300 units/ml (T insulin glargine 300 units/ml (T oujeo oujeo) ) Evidence summary Published: 13 October 2015 nice.org.uk/guidance/esnm62 pathways K Ke ey points from the e y points from the evidence vidence The content of this evidence summary was up-to-date in October 2015. See summaries (...) oujeo). In 1 RCT (n=549), similar numbers of participants reported injection site reactions with T oujeo (2.2%) and Lantus (1.5%), and similar numbers withdrew because of adverse events (1.1% in both groups). Type 1 diabetes mellitus in adults: high-strength insulin glargine 300 units/ml (Toujeo) (ESNM62) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 22P Patient factors atient factors T oujeo is a high

2015 National Institute for Health and Clinical Excellence - Advice

18. Dapagliflozin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V (new scientific findings)

Dapagliflozin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V (new scientific findings) Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Dapagliflozin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 March 2018). 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. A17-65 Dapagliflozin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 (new scientific findings) Extract of dossier assessment A17-65 Version 1.0 Dapagliflozin (type 2 diabetes mellitus) 28 March 2018 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) – Benefit assessment according to §35a Social

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Dapagliflozin/metformin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V (new scientific findings) 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 (Version 1.0; Status: 28 March 2018). 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 A17-66 Dapagliflozin/metformin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 (new scientific findings) Extract of dossier assessment A17-66 Version 1.0 Dapagliflozin/metformin (type 2 diabetes mellitus) 28 March 2018 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) – Benefit

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

20. Sitagliptin (type 2 diabetes mellitus) - Benefit assessment according to § 35a Social Code Book V (expiry of the decision)

Sitagliptin (type 2 diabetes mellitus) - Benefit assessment according to § 35a Social Code Book V (expiry of the decision) Extract 1 Translation of the executive summary of the dossier assessment Sitagliptin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 19 December 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. A18-65 Sitagliptin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A18-65 Version 1.0 Sitagliptin (type 2 diabetes mellitus) 19 December 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Sitagliptin (type 2 diabetes mellitus

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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