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Skin Conditions in Diabetes Mellitus

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81. Management of Diabetic Foot

Diabetic foot can be defined as infection, ulceration or destruction of tissues of the foot associated with neuropathy and/or peripheral arterial disease of people with diabetes mellitus (DM). 1 About 80% of non-traumatic lower limb amputations in patients with diabetes are preceded by a foot ulcer. Around 50% of patients with diabetes die within five years of developing a foot ulcer, and up to 70% die within five years after an amputation. 2 It also accounts for substantial health care resources. Thus (...) Practice Guidelines published in 2015 (available at http://www.moh. gov.my/penerbitan/mymahtas/CPG_MANUAL_MAHTAS.pdf). vManagement of Diabetic Foot (Second Edition) OBJECTIVES The objectives of the CPG are to provide evidence-based recommendations on the management of diabetic foot in the following aspects: a. assessment b. referral c. prevention d. treatment CLINICAL QUESTIONS Refer to Appendix 2. TARGET POPULATION Inclusion Criteria All patients with diabetes mellitus who are at risk or have

2018 Ministry of Health, Malaysia

82. Type 1 diabetes in adults: diagnosis and management

Type 1 diabetes in adults: diagnosis and management T T ype 1 diabetes in adults: diagnosis and ype 1 diabetes in adults: diagnosis and management management NICE guideline Published: 26 August 2015 nice.org.uk/guidance/ng17 © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility The recommendations in this guideline represent the view of NICE, arrived at after careful consideration (...) be inconsistent with complying with those duties. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Type 1 diabetes in adults: diagnosis and management (NG17) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 87Contents Contents Overview 5 Who

2015 National Institute for Health and Clinical Excellence - Clinical Guidelines

83. MiniMed 640G system with SmartGuard for managing blood glucose levels in people with type 1 diabetes

. © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 1 of 23Product summary and likely place in therapy The MiniMed 640G system combines a continuous glucose monitor and insulin pump to automatically deliver insulin and maintain blood glucose levels within a pre-set range. The system would be used by people with type 1 diabetes who have episodes of disabling hypoglycaemia despite optimal management with continuous (...) participants reached the pre-set blood glucose threshold when SmartGuard was on, compared with 9 of 10 participants when SmartGuard was off. One case series of 22 patients with type 1 diabetes showed that hypoglycaemia was prevented in 12 out of 15 patients during an exercise session. MiniMed 640G system with SmartGuard for managing blood glucose levels in people with type 1 diabetes (MIB51) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice

2016 National Institute for Health and Clinical Excellence - Advice

84. Management of glycaemic control in pregnant women with diabetes on obstetric wards and delivery units

of Diabetes in Hospital March 2012 JBDS 04 Management of adults with diabetes undergoing surgery and elective procedures: improving standards April 2011 JBDS 03 The Management of Diabetic Ketoacidosis in Adults Revised September 2013 JBDS 02 The Hospital Management of Hypoglycaemia in Adults with Diabetes Mellitus Revised September 2013 JBDS 01 These documents are available to download from the ABCD website at www.diabetologists-abcd.org.uk/JBDS/JBDS.htm and the Diabetes UK website at www.diabetes.org.uk (...) on the breath (sometimes described as ‘pear drops’) and coma. Ketoacidosis should always be considered when a pregnant woman with diabetes feels unwell. These women must be assessed by a medical or diabetes team. 8.1 Diagnosis of DKA: 1. Presence of diabetes mellitus (of any kind, DKA can occur in pregnancy in a woman with known diabetes with a normal blood glucose). AND: 2. Ketosis: urinary ketones >++ or blood ketones >3.0 mmol/L (high risk 1.5 mmol/L) AND 3. Acidosis: blood gas pH 4 kg, neonatal

2017 Association of British Clinical Diabetologists

85. Integrated sensor-augmented pump therapy systems for managing blood glucose levels in type 1 diabetes (the MiniMed Paradigm Veo system and the Vibe and G4 PLATINUM CGM system)

tubing and a cannula Integrated sensor-augmented pump therapy systems for managing blood glucose levels in type 1 diabetes (the MiniMed Paradigm Veo system and the Vibe and G4 PLATINUM CGM system) (DG21) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 11 of 50that is placed under the skin. The pump can be programmed to deliver a basal rate of insulin throughout the day, with higher infusion rates triggered by pushing (...) through a cannula placed under the skin. Integrated sensor-augmented pump therapy systems for managing blood glucose levels in type 1 diabetes (the MiniMed Paradigm Veo system and the Vibe and G4 PLATINUM CGM system) (DG21) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 12 of 50The pump can be programmed to deliver a basal rate of insulin throughout the day, with the option of triggering higher infusion rates at meal

2016 National Institute for Health and Clinical Excellence - Diagnostics Guidance

86. Islet Cell Replacement Therapy for Insulin-Dependent Diabetes

that may help protect them from the immune system. 3,5 The PEC-Direct Product The PEC-Direct product contains PEC-01 cells; it is surgically implanted under the skin during an outpatient procedure. 9 Due to the auto-immune nature of type 1 diabetes, as well as the fact that these cells are allogeneic (genetically similar but not identical), patients are expected to require immunosuppression for the rest of their lives. 3,4 The risks of lifelong immunosuppression include an increased risk of infections (...) PEC-Encap product uses the same PEC-01 cells as the PEC-Direct product, and it is also implanted under the skin during an outpatient procedure. 3,10 However, the PEC-Encap product takes the PEC-Direct technology one step further by enclosing the cells in a semi-permeable encapsulation device. The device — called the Encaptra drug delivery system — is hypothesized to prevent the need for immunosuppression. 3,7,9-11 The PEC-Encap product is intended for all people living with type 1 diabetes as well

2017 CADTH - Issues in Emerging Health Technologies

87. New Drugs for Type 2 Diabetes: Second-Line Therapy — Recommendations Report

-line agent: sulfonylurea, insulin, DPP-4 inhibitor, GLP-1 analogue, or SGLT-2 inhibitor? Patient Considerations Diabetes Canada provided the only patient submission for consideration in this therapeutic review. Information in Diabetes Canada’s submission was gathered through a series of surveys involving individuals living with type 2 diabetes. Patients expressed frustration with having to cope with diabetes, a condition that negatively impacts all areas of their lives. Patients (...) and their caregivers experience these impacts in their daily activities, work, travel, and social life. It was noted that a high proportion of the survey respondents have advanced diabetes and experience a range of complications and/or comorbidities. These include neuropathy, foot complications, cardiovascular disease, eye problems or loss of vision, kidney complications, pancreatitis, skin ulcers, erectile dysfunction, and amputations. Patients noted that there is stigma associated with diabetes that can create

2017 CADTH - Plasma Products

88. A Hybrid Closed-Loop Insulin Delivery System for the Treatment of Type 1 Diabetes

Efficacy: % of time in closed-loop mode: median 87.2% A1C levels: dropped from a mean of 7.4% to 6.9% Daily insulin dose: increased from 47.5 U to 50.9 U % of glucose in target range: increased from 66.7% to 72.2% A1C = glycated hemoglobin; AE = adverse event; CA = California; DKA = diabetic ketoacidosis; DM = diabetes mellitus; MN = Minnesota; NR = not reported; RCT = randomized controlled trial; SAE = serious adverse event; SD = standard deviation; T1DM = type 1 diabetes mellitus; U = unit; vs (...) , with T1DM 4 study arms: MDI 670G 670G without the glucose sensor 670G without low management suspend Follow-up = 6 months Safety: Event rates of severe hypoglycemia and DKA Efficacy: % of time blood glucose is in the target range (3.9 mmol/L to 10.0 mmol/L), and < 3.9 mmol/L; change in A1C A1C = glycated hemoglobin; DKA = diabetic ketoacidosis; DM = diabetes mellitus; MDI = multiple daily injections; NIDDK = National Institute of Diabetes and Digestive and Kidney Diseases; QoL = quality of life; T1DM

2017 CADTH - Issues in Emerging Health Technologies

89. Flash Glucose Monitoring System for Diabetes

, mealtime insulin. 3 Some people with hard-to-control type 1 diabetes may opt for continuous glucose monitoring with devices that continuously measure glucose levels using a sensor implanted under the skin. 3 Other people may opt for continuous monitoring because they find the number of finger sticks required for self-monitoring to be painful and inconvenient. A new approach to glucose monitoring, called flash glucose monitoring, is becoming available and may offer people with type 1 and type 2 diabetes (...) interval; Dexcom = Dexcom G4 Platinum continuous glucose monitoring system; FSL = FreeStyle Libre system; MARD = mean absolute relative difference; MD-CGM = intravascular microdialysis continuous glucose monitoring; Medtronic = Medtronic MiniMed 640G insulin pump; pts = patients; SMBG = self-monitoring of blood glucose; T1DM/T2DM = type 1 and type 2 diabetes mellitus; vs. = versus; YSI = Yellow Springs Instrument Company. a Error grid analysis pairs glucose samples in five zones (A, B, C, D, and E). 32

2017 CADTH - Issues in Emerging Health Technologies

90. Islet Cell Replacement Therapy for Insulin-Dependent Diabetes

that may help protect them from the immune system. 3,5 The PEC-Direct Product The PEC-Direct product contains PEC-01 cells; it is surgically implanted under the skin during an outpatient procedure. 9 Due to the auto-immune nature of type 1 diabetes, as well as the fact that these cells are allogeneic (genetically similar but not identical), patients are expected to require immunosuppression for the rest of their lives. 3,4 The risks of lifelong immunosuppression include an increased risk of infections (...) PEC-Encap product uses the same PEC-01 cells as the PEC-Direct product, and it is also implanted under the skin during an outpatient procedure. 3,10 However, the PEC-Encap product takes the PEC-Direct technology one step further by enclosing the cells in a semi-permeable encapsulation device. The device — called the Encaptra drug delivery system — is hypothesized to prevent the need for immunosuppression. 3,7,9-11 The PEC-Encap product is intended for all people living with type 1 diabetes as well

2017 CADTH - Issues in Emerging Health Technologies

91. New Drugs for Type 2 Diabetes: Second-Line Therapy — Recommendations Report

-line agent: sulfonylurea, insulin, DPP-4 inhibitor, GLP-1 analogue, or SGLT-2 inhibitor? Patient Considerations Diabetes Canada provided the only patient submission for consideration in this therapeutic review. Information in Diabetes Canada’s submission was gathered through a series of surveys involving individuals living with type 2 diabetes. Patients expressed frustration with having to cope with diabetes, a condition that negatively impacts all areas of their lives. Patients (...) and their caregivers experience these impacts in their daily activities, work, travel, and social life. It was noted that a high proportion of the survey respondents have advanced diabetes and experience a range of complications and/or comorbidities. These include neuropathy, foot complications, cardiovascular disease, eye problems or loss of vision, kidney complications, pancreatitis, skin ulcers, erectile dysfunction, and amputations. Patients noted that there is stigma associated with diabetes that can create

2017 CADTH - Plasma Products

92. Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada : Diabetes in the elderly

of diabetes care, particularly for older adults who may require additional education and support in light of other chronic conditions and polypharmacy . Recently, a population-based cohort study of older adults (≥65 years of age) living in Ontario found that attendance at a diabetes education program was associated with better quality of care, and better participation relating to education utilization and retinopathy screening . A review of diabetes self-management programs for older adults ≥65 years (...) and insulin sensitivity in these people, although this is controversial . Older women with diabetes have a greater decline in walking speed when compared to a control group without diabetes . In the older population with diabetes, higher levels of physical activity are associated with greater survival . Physical training programs can be successfully implemented in older people with diabetes, although comorbid conditions may prevent aerobic physical training in many patients, and increased activity levels

2013 CPG Infobase

93. Topically Applied Bisphosphocin Nu-3 on Infected Diabetic Ulcers of Subjects With Type I or II Diabetes Mellitus

14, 2016 Last Update Posted : September 5, 2017 Sponsor: Lakewood-Amedex Inc Information provided by (Responsible Party): Lakewood-Amedex Inc Study Details Study Description Go to Brief Summary: Phase I/IIa, five cohort ascending dose with two dosing arms per cohort, study in Type I or II diabetes mellitus subjects with a chronic infected diabetic ulcer defined as having a DUSS score of 0 to 3 and DFI wound score of 1 to 3. Condition or disease Intervention/treatment Phase Diabetic Foot (...) relevant MeSH terms: Layout table for MeSH terms Diabetes Mellitus Diabetic Foot Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Foot Ulcer Leg Ulcer Skin Ulcer Skin Diseases Diabetes Complications Diabetic Neuropathies

2016 Clinical Trials

94. Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada

at risk of diabetes will continue to ?nd the evidence compiled in these guidelinesavitalaidandresourceintheirefforts.Wearecon?dent that, ultimately, if applied properly, these guidelines will lead to improved quality of care, reduced morbidity and mortality from diabetesanditscomplications,andabetterqualityoflifeforpeople living with this chronic disease. The Challenge of Diabetes Diabetes mellitus is a serious condition with potentially devas (...) : a consensus on type 2 diabetes prevention. Diabet Med 2007;24:451e63. 5. McManus R. Time for action: a Canadian proposal for primary prevention of type 2 diabetes. Can J Diabetes 2012;36:44e9. 6. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long- term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977e86. 7. Nathan DM, Cleary PA, Backlund JY, et al. Diabetes Control

2013 CPG Infobase

95. Investigating the Safety Profile of Liraglutide Under Normal Conditions of Use in Korean Subjects With Type 2 Diabetes Mellitus

Investigating the Safety Profile of Liraglutide Under Normal Conditions of Use in Korean Subjects With Type 2 Diabetes Mellitus Investigating the Safety Profile of Liraglutide Under Normal Conditions of Use in Korean Subjects With Type 2 Diabetes Mellitus - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached (...) the maximum number of saved studies (100). Please remove one or more studies before adding more. Investigating the Safety Profile of Liraglutide Under Normal Conditions of Use in Korean Subjects With Type 2 Diabetes Mellitus The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT01821846 Recruitment Status

2013 Clinical Trials

96. Empagliflozin / linagliptin (Glyxambi) - type 2 diabetes

cutaneous adverse reaction Summary of Clinical Efficacy SCS Summary of Clinical Safety SD Standard deviation SE Standard error SGLT SGOT Sodium-dependant glucose co-transporter Serum glutamic oxaloacetic transaminase SmPC Summary of Product Characteristics SMQ Standardised MedDRA query SOC T2DM System-organ class Type 2 diabetes mellitus TS Treated set UACR Urinary-albumin-to-creatinine ratio UGT Uridine 5'-diphospho-glucuronosyltransferases ULN Upper limit of normal USPI URTI UTI UV vPvB ZDF United (...) the Article 3(1) and point 3 of Annex of Regulation (EC) No 726/2004. The eligibility to the centralised procedure was agreed upon by the EMA/CHMP on 25 July 2013. The applicant applied for the following indication: Glyxambi is indicated in adults with type 2 diabetes mellitus to improve glycaemic control: • when diet and exercise, plus metformin and a sodium glucose co-transporter 2 (SGLT2) inhibitor do not provide adequate glycaemic control, • when diet and exercise, plus metformin and a dipeptidyl

2016 European Medicines Agency - EPARs

97. Point-of-care devices for detecting diabetic polyneuropathy

review had revealed that sensitivity for monofilament testing ranged from 41% to 93% and specificity ranged from 68% to 100% but no meta-analysis could be performed due to the heterogeneous nature of the studies (6). Point-of-care devices for detecting diabetic polyneuropathy Horizon Scan Report 0046 July 2016 Importance: Diabetes mellitus is a highly prevalent chronic condition. According to the NHS Information Centre in 2013 the prevalence in the UK was 5.8% and diabetes is in the top five highly (...) prevalent chronic conditions in UK. DPN is one of the most common complications of diabetes mellitus (1); up to 50% of diabetic patients can suffer from polyneuropathy and 50% of these patients are asymptomatic (7). Diabetic neuropathy can lead to complications such as lower limb ulceration and, in more advanced cases, lower limb amputation. DPN is the most common cause of hospitalisation due to complications secondary to diabetes and DPN is the leading cause of non-traumatic lower limb amputation (2

2016 Publication 4878904

98. On the Level: Evidence for action on type 2 diabetes

that indicates blood glucose levels over a period of time) NHS national health Service NICE the national Institute for health and Care excellence NIHR national Institute for health Research SIGN Scottish Intercollegiate Guidelines network whAt is type 2 diAbetes? Diabetes is a long term condition that causes a person’s blood sugar level to become too high. this can lead to a number of health problems. Sugar levels in the blood are controlled by the hormone insulin which is produced by the pancreas (...) seven years. this surgery can even lead to remission of diabetes in around a third of obese people with the condition. » ‘One size fits all’ social marketing campaigns or interventions may not work to prevent diabetes, owing to diverse cultural beliefs and traditions. » With more people developing type 2 diabetes at an early age, research efforts are underway to identify the best ways of preventing the condition in young people. identifying people with type 2 diAbetes » For people at high risk

2016 Publication 4887694

99. Type 2 diabetes: alogliptin

therapy (2.3%, 9/399) experienced drug-related skin and subcutaneous disorders, most commonly pruritus and rash (statistical Type 2 diabetes: alogliptin (ESNM20) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 18 of 25significance not reported). Hypoglycaemia was also reported by proportionally more patients on triple therapy (4.5%, 18/404, 2 cases were severe) compared with dual therapy (1.5%, 6/399), but again (...) . Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 1 of 25Effectiv Effectiveness eness Alogliptin as add-on therapy reduces HbA1c by around 5.5 mmol/mol (0.5%) compared with placebo (4 RCTs of dual therapy lasting 26 weeks, 2 RCTs of triple therapy lasting 26 and 52 weeks). Safety Safety No serious safety concerns have emerged so far. Proportionally more hypoglycaemia and drug-related skin and subcutaneous disorders with alogliptin triple therapy

2013 National Institute for Health and Clinical Excellence - Advice

100. Diabetes - type 2

likely in a person with: No additional features of type 1 diabetes (such as rapid onset, often in childhood, insulin dependence, or ketoacidosis) — see the CKS topic on for more information. No features of monogenic diabetes or diabetes secondary to a pathological condition or disease, drug treatment, trauma, or pancreatic surgery. When to avoid HbA1c or interpret results with caution When to avoid HbA1c or interpret results cautiously HbA1c should not be used to diagnose diabetes mellitus (...) Diabetes - type 2 Diabetes - type 2 - NICE CKS Share Summary: Diabetes - type 2 Diabetes mellitus is a group of metabolic disorders characterized by persistent hyperglycaemia (HbA1c more than 48 mmol/mol [6.5%] or random plasma glucose more than 11 mmol/L). Type 2 diabetes is caused by a combination of insulin resistance (where the body is unable to respond to normal levels of insulin) and insulin deficiency (where the pancreas is unable to secrete enough insulin to compensate

2019 NICE Clinical Knowledge Summaries

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