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Skin Conditions in Diabetes Mellitus

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121. 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

122. 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

123. 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

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

diabetes mellitus must check their blood glucose — or blood sugar — levels several times a day and then calculate and inject an appropriate insulin dosage. Wearable systems, sometimes referred to as an “artificial pancreas,” are now available to replicate some of the functions of the pancreas in controlling insulin delivery. The MiniMed 670G is currently the only hybrid closed-loop system licensed for commercial use. Available evidence supports the safety of the MiniMed 670G system for individuals (...) the body uses fat instead of sugar to make energy. 1,2 These conditions, as well as high and low swings in blood glucose levels, are associated with increased morbidity and mortality. 1 Wearable systems are available for the continuous management of type 1 diabetes. These systems are intended to control blood glucose during particularly challenging times, such as overnight, at meal times, and when exercising. 3 Automating the delivery of insulin in wearable systems combines three functions: continuous

2017 CADTH - Issues in Emerging Health Technologies

125. 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

126. 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

127. 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 NIHR DEC Oxford

128. Candida - skin

of immunosuppressive drugs [such as corticosteroids]). General debility, for example from cancer or malnutrition. Recent or concurrent use of drugs that promote candidal growth, particularly broad-spectrum antibiotics and inhaled or oral corticosteroids. Extremes of ages — due to immature or weakened immunity. Diseases in which the barrier function of the skin is disturbed (such as psoriasis and seborrhoeic eczema). Endocrine disorders, such as: Diabetes mellitus — see the CKS topics on and for more information (...) diagnose a candidal skin infection? The diagnosis of candidal skin infection is usually made from characteristic clinical features. The appearance of the skin is variable, depending on the . Soreness and itching is usual. Thin-walled pustules with a red base may be present. Scales may accumulate, producing a white-yellow, curd-like substance over the infected area. In flexural areas (intertrigo), the skin fold is typically red and moist. As the condition develops, a typical fringed, irregular edge

2017 NICE Clinical Knowledge Summaries

129. A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SAR438544 in Comparison to Glucagon in Type 1 Diabetes Mellitus Patients Under Induced Hypoglycemia

recombinant glucagon in type 1 diabetes mellitus (T1DM) patients under induced hypoglycemia. Secondary Objective: To assess the safety and tolerability and pharmacokinetics (PK) of a single SC dose of SAR438544 versus recombinant glucagon in T1DM patients under induced hypoglycemia. Condition or disease Intervention/treatment Phase Type 1 Diabetes Mellitus Drug: SAR438544 Drug: r-glucagon Drug: insulin Phase 1 Detailed Description: The total duration of study per patient is up to 8 weeks with 3 to 28 days (...) A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SAR438544 in Comparison to Glucagon in Type 1 Diabetes Mellitus Patients Under Induced Hypoglycemia A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SAR438544 in Comparison to Glucagon in Type 1 Diabetes Mellitus Patients Under Induced Hypoglycemia - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration

2015 Clinical Trials

130. A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus.

in Japanese subjects with type 2 diabetes mellitus. Condition or disease Intervention/treatment Phase Diabetes Diabetes Mellitus, Type 2 Drug: insulin degludec/liraglutide Drug: insulin degludec Drug: liraglutide Phase 3 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 819 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Trial Comparing (...) A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus. A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese 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

2015 Clinical Trials

131. A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Doses of SAR438544 in Comparison to Placebo and Glucagon in Healthy Subjects and Type 1 Diabetes Mellitus Patients

subcutaneous (SC) doses in healthy subjects and in type 1 diabetes mellitus (T1DM) patients. Secondary Objective: To assess the preliminary pharmacodynamics (PD) and pharmacokinetic (PK) parameters of SAR438544 after single ascending SC doses in healthy subjects and in T1DM patients. Condition or disease Intervention/treatment Phase Type 1 Diabetes Mellitus Drug: SAR438544 Drug: placebo Drug: r-glucagon Phase 1 Detailed Description: Healthy subjects: The total duration of study per subject is up to 4.5 (...) A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Doses of SAR438544 in Comparison to Placebo and Glucagon in Healthy Subjects and Type 1 Diabetes Mellitus Patients A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Doses of SAR438544 in Comparison to Placebo and Glucagon in Healthy Subjects and Type 1 Diabetes Mellitus Patients - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer

2015 Clinical Trials

132. A Study of a Novel Insulin Lispro Formulation in Participants With Type 1 Diabetes Mellitus Using Insulin Pumps

) First Posted : December 7, 2015 Last Update Posted : July 13, 2017 Sponsor: Eli Lilly and Company Information provided by (Responsible Party): Eli Lilly and Company Study Details Study Description Go to Brief Summary: This study evaluates a new test formulation of a glucose lowering drug, insulin lispro, delivered by an insulin pump continuously under the skin. The study will be conducted in participants with type 1 diabetes mellitus to investigate how the human body processes the new test (...) formulation and its effect on blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability will be documented. The study will last about 4 to 11 weeks, including screening, lead-in and follow up. Screening is required within 28 days prior to entering the study. Condition or disease Intervention/treatment Phase Diabetes Mellitus, Type 1 Drug: Insulin Lispro Phase 1 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual

2015 Clinical Trials

133. A Study to Assess the Addition of Sitagliptin to Metformin Compared With the Addition of Dapagliflozin to Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) and Mild Renal Impairment Who Have Inadequate Glycemic Control on Metformin With or Wi

as well as the overall safety and tolerability of sitagliptin in comparison to that of dapagliflozin after 24 weeks of treatment. The primary hypothesis is that the change from baseline in A1C in participants treated with the addition of sitagliptin is non-inferior compared to that in participants treated with the addition of dapagliflozin after 24 weeks of treatment. Condition or disease Intervention/treatment Phase Type 2 Diabetes Mellitus Drug: Sitagliptin Drug: Dapagliflozin Drug: Metformin Drug (...) A Study to Assess the Addition of Sitagliptin to Metformin Compared With the Addition of Dapagliflozin to Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) and Mild Renal Impairment Who Have Inadequate Glycemic Control on Metformin With or Wi A Study to Assess the Addition of Sitagliptin to Metformin Compared With the Addition of Dapagliflozin to Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) and Mild Renal Impairment Who Have Inadequate Glycemic Control

2015 Clinical Trials

134. A Study to Assess Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus

provided by (Responsible Party): CeQur Corporation Study Details Study Description Go to Brief Summary: The purpose of the study is to obtain an assessment (efficacy, safety, and patient reported outcomes) of basal bolus insulin delivery with PaQ in insulin-using patients with type 2 diabetes mellitus (T2DM). Condition or disease Intervention/treatment Phase Type 2 Diabetes Mellitus Device: PaQ® Insulin Delivery Device Drug: Insulin, Asp(B28)- Not Applicable Detailed Description: This is a prospective (...) A Study to Assess Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus A Study to Assess Insulin Delivery With PaQ® in Patients 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

2015 Clinical Trials

135. A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus

therapy in combination with metformin in subjects with type 2 diabetes mellitus. Condition or disease Intervention/treatment Phase Diabetes Diabetes Mellitus, Type 2 Drug: insulin degludec/liraglutide Drug: insulin glargine Drug: insulin aspart Phase 3 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 506 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment (...) A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in 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

2015 Clinical Trials

136. TAK-648 in Healthy Japanese Participants and Non-Japanese Participants With Type 2 Diabetes Mellitus

as multiple oral doses of TAK-648 solution at escalating dose levels in healthy participants of Japanese decent and participants with T2DM. Condition or disease Intervention/treatment Phase Type 2 Diabetes Mellitus Drug: TAK-648 Drug: Placebo Phase 1 Detailed Description: The drug being evaluated in this study is TAK-648 for the treatment of T2DM. This study will consist of 2 parts: (1) multiple ascending doses in participants with T2DM treated with a stable dose of metformin, (2) multiple ascending doses (...) TAK-648 in Healthy Japanese Participants and Non-Japanese Participants With Type 2 Diabetes Mellitus TAK-648 Multiple-Rising Dose Study in Healthy Japanese Participants and Non-Japanese Participants 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

2015 Clinical Trials

137. Efficacy and Safety Study of PEX168 in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin

controlled blood glucose (7.0%≤HbA1c≤10.5% at randomization)despite at least 8 weeks of metformin monotherapy at stable doses(≥1500 mg/day). Condition or disease Intervention/treatment Phase Type 2 Diabetes Mellitus Drug: PEX168(100µg) Drug: PEX168(200µg) Drug: Placebo Drug: Metformin Phase 3 Detailed Description: Subjects will be randomized to receive either PEX168 100μg, 200μg or PEX 168 Dummy Injection as add-on to metformin hydrochloride. The baseline HbA1c level (HbA1c≤8.5% or HbA1c>8.5)is designed (...) Efficacy and Safety Study of PEX168 in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin Efficacy and Safety Study of PEX168 in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin - 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

2015 Clinical Trials

138. Single Dose Clamp Study to Evaluate Concentration-time Profile and Metabolic Activity of 3 Dose Levels of Afrezza and 3 Dose Levels of Insulin Lispro in Patients With Type 1 Diabetes Mellitus

Technosphere insulin and of 3 single doses of SC insulin lispro in a euglycemic clamp setting. To assess the pharmacokinetic (PK) characteristics of 3 different single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a euglycemic clamp setting. To assess the safety and tolerability of 3 different single doses of Afrezza inhaled Technosphere insulin. Condition or disease Intervention/treatment Phase Type 1 Diabetes Mellitus Drug: SAR439065 Drug: Insulin lispro (...) months prior to study (with respect to safety of the patient and scientific integrity of the study). Certified as otherwise healthy for type 1 diabetes mellitus patient by assessment of medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and musculoskeletal system), unless the Investigator considers any abnormality to be clinically irrelevant and not interfering with the conduct of the study (with respect to safety

2015 Clinical Trials

139. Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus

: September 6, 2018 Sponsor: Novo Nordisk A/S Information provided by (Responsible Party): Novo Nordisk A/S Study Details Study Description Go to Brief Summary: This trial is conducted globally. The aim of this trial is to investigate safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus. Condition or disease Intervention/treatment Phase Metabolism and Nutrition Disorder Obesity Drug: semaglutide Drug: liraglutide Drug: placebo Phase 2 Study Design Go to Layout table (...) Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without 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

2015 Clinical Trials

140. Study of KD026 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus

provided by (Responsible Party): Kadmon Corporation, LLC Study Details Study Description Go to Brief Summary: This study will compare the safety, tolerability and efficacy of the combination of KD026 and metformin compared to placebo and metformin on improving glycemic control in patients with type 2 diabetes mellitus. Condition or disease Intervention/treatment Phase Type 2 Diabetes Mellitus Drug: KD026 Drug: Placebo Drug: Metformin Phase 2 Study Design Go to Layout table for study information Study (...) Study of KD026 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus Study of KD026 in Combination With Metformin in 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

2015 Clinical Trials

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