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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT04030013 Completed - Diabetes Mellitus Clinical Trials

"Outcome of Diabetes Education Among Renal Transplant Recipients With New Onset Diabetes After Transplantation (NODAT)"

NODAT-ES
Start date: May 2015
Phase: N/A
Study type: Interventional

Introduction: Diabetes is a chronic disease that requires lifelong self care behavior. Successful treatment of chronic diseases is closely associated with the education of both patients and their relatives. Patient education is one of the most important responsibilities of diabetes nurse educators. In the management of diabetes, helping patients to improve their health and quality of life is considered an important aspect of diabetes self-care education. Solid organ transplantation is now the standard of care for end-stage organ failure. New-onset diabetes mellitus after solid organ transplantation (NODAT) has emerged as an increasingly important determinant of outcomes and survival in transplant recipients. Patient education and self-management are crucial for ensuring successful outcome post transplantation. No adequate studies concerning education of diabetic renal transplants. Aim of the work: The aim of this work is to evaluate the effect of diabetes education given to renal transplant recipients with new onset diabetes after transplantation (NODAT) on their self-care activities and metabolic control variables and reversibility of the present chronic diabetic complications. Patients and methods: The study will involve 210 diabetic renal transplant patients (NODAT) who will be referred from Hamed Al-Essa organ transplant center to Dasman Diabetes Institute. These patients will be sub-divided into three subgroups: patients who will receive group education (n=70) will represent group1, patients who will receive one to one education (n=70) will represent group 2, while those who will receive the conventional (not structured) education program will serve as control group 3(n= 70). All patients of group 1 and 2 will receive intensive education for 3-4 months, then refreshment session every 3 months for 2 years. Initially, patient data will be collected through 3 types of forms: patient identification form, metabolic control parameters form and diabetes self-care scale questionnaire; then every 6 months metabolic parameters and diabetes self-care scale questionnaire will be reassessed. Expected outcome: Patient education given to transplant recipients with NODAT could affect patients' self-care activities, metabolic control positively and possibly help in reversal of chronic diabetic complications

NCT ID: NCT04028427 Completed - Clinical trials for Diabetes Mellitus, Type 2

Impact of ACT-based Interventions on Diabetes-related Outcomes

Start date: October 14, 2019
Phase: N/A
Study type: Interventional

Individuals with insulin-treated diabetes can experience psychological difficulties associated with living with and managing the condition. Acceptance and Commitment Therapy (ACT) is being increasingly used to treat these psychological difficulties, with research in this area indicating positive psychological and diabetes-related outcomes (Gregg, Callaghan, Hayes, & Glenn-Lawson, 2007; Shayeghian, Hassanabadi, Aguilar-Vafaie, Amiri, & Besharat, 2016). Given the lack of psychology funding in diabetes care provision, a financially feasible theory-based intervention is much-needed (Diabetes UK, 2008). ACT may be the solution as it can be delivered in smaller modules. The study aims to investigate the effectiveness of two online ACT-based interventions (a mindfulness-based intervention [MBI] and a values-plus-goals intervention [VGI]) on wellbeing, diabetes self-management, coping style and glycaemic control among a sample of adults with insulin-treated diabetes. It also aims to examine whether the interventions are associated with changes in diabetes acceptance and valued living, and whether diabetes acceptance and valued living are associated with the aforementioned outcomes. Participants will be recruited from the diabetes outpatient clinics at Ashford and St. Peter's Hospitals NHS Foundation Trust to take part in the study. They will be randomly assigned to take part in either the MBI or VGI, which are both 4-week interventions. Participants will be asked to complete self-report questionnaires to measure their wellbeing, diabetes self-management, coping style, diabetes acceptance and valued living at the beginning of the study, at the end of the intervention and at a 1-month follow-up. Glycaemic control will be measured at the beginning of the study and at a 2-month follow up. It is hypothesised that both interventions will improve diabetes-related outcomes. It is hypothesised that MBI may be associated with increases in acceptance and more positive emotion focused coping, whereas the VGI may be associated with increased valued living and problem-focused/active coping.

NCT ID: NCT04023734 Completed - Hypertension Clinical Trials

A Targeted and Tailored Pharmacist Intervention to Improve Adherence to Antihypertensive Drugs Among Diabetes Patients

Start date: August 16, 2019
Phase: N/A
Study type: Interventional

The primary objective of this study is to assess the effect of a targeted and tailored pharmacist intervention on medication adherence among diabetes patients non-adherent to antihypertensive drugs. The secondary objectives are to assess the effect of the intervention on blood pressure level and medication beliefs, and to evaluate the implementation and adoption of the intervention for pharmacists and patients.

NCT ID: NCT04023487 Completed - Clinical trials for Diabetes Mellitus, Type 1

Evaluation of an Intervention for Young Adults With Diabetes: Resilient, Empowered, Active Living-Telehealth (REAL-T)

REAL-T
Start date: October 22, 2019
Phase: N/A
Study type: Interventional

This study will evaluate (1) the efficacy of REAL-T, a lifestyle-based telehealth intervention, in improving glycemic control (HbA1c) and psychosocial outcomes, (2) which effects are retained over a 6-month follow-up period, and (3) the mediating mechanisms responsible for the intervention's effects. Half of participants will receive REAL-T, while the other half will receive their usual care.

NCT ID: NCT04023344 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Insulin Lispro Biphasic 25 Compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients

Start date: March 14, 2018
Phase: Phase 3
Study type: Interventional

The study is designed to approve non-inferior efficacy and safety of Insulin Lispro Biphasic 25 ("Geropharm") compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients.

NCT ID: NCT04022993 Completed - Diabetes Mellitus Clinical Trials

Efficacy and Safety of Insulin RinGlar® Compared to Lantus® SoloStar® in Type 1 Diabetes Mellitus Patients

Start date: July 4, 2018
Phase: Phase 3
Study type: Interventional

The study is designed to approve non-inferior efficacy and safety of Insulin RinGlar® compared to Lantus® SoloStar® in Type 1 Diabetes Mellitus Patients.

NCT ID: NCT04021199 Completed - Diabetes Mellitus Clinical Trials

Screening for Genetic Forms of Diabetes in Convention of Care for Children and Adolescents With Diabetes (GENEPEDIAB)

GENEPEDIAB
Start date: October 22, 2018
Phase: N/A
Study type: Interventional

Background/Aims: Diabetes, which affects 420 million people worldwide with a continuously rising incidence, is defined by a state of chronic hyperglycemia; a criterion referring to a heterogeneous group of diseases with various etiologies and distinct therapeutic options. Besides the two main forms of diabetes (i.e., type 1 (T1D) and type 2 (T2D)), there are rare subtypes of the disease called monogenic diabetes (or formerly MODY) that are hardly diagnosed because of their resemblance to T1D or T2D. Since these monogenic diabetes may appear early in life, a consortium of expert pediatric clinical centers was created under a clinical research initiative (the GENEPEDIAB study) to develop tools for accurate diagnosis of rare diabetes and to propose appropriate care to these children and adolescents wrongly assigned to T1D or T2D cohorts. The GENEPEDIAB study was initiated in the context of a broader collaborative project (DiaType) with the objective to develop personalized diabetes medicine and better patient care. Methods: For discrimination of patients with monogenic diabetes from those with classical forms of diabetes using the MODY probability calculator, patients enrolled in the GENEPEDIAB study are phenotyped and genotyped for T1D risk (anti-islet antibodies and HLA). Patients fulfilling sufficient criteria are then genotyped using the routine MODY panel, before being proposed a thorough gene analysis. More comprehensive genetic tests will be conducted in patients without anomalies found after the MODY gene-sequencing test. Perspective: the GENEPEDIAB study will enable the investigators to adapt treatment to diabetes etiology and help to provide genetic counseling to patients and their family members. The investigators anticipate that its broad genetic analyses will provide them with important information about the genetic susceptibility of these subgroups of patients with atypical diabetes.

NCT ID: NCT04019821 Completed - Clinical trials for Diabetes Mellitus, Type 1

Super-Bolus: Effects on Postprandial Glycemia After High Glycemic Index Meal

Start date: January 1, 2020
Phase: Phase 4
Study type: Interventional

The aim of this study is to determine whether Super-Bolus is more effective in postprandial glycemic control than Normal-Bolus after the high glycemic index (H-GI) meal in children with type 1 diabetes (T1DM) treated with insulin pump (continuous subcutaneous insulin infusion, CSII).

NCT ID: NCT04017832 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin in People With Type 2 Diabetes

PIONEER 12
Start date: July 29, 2019
Phase: Phase 3
Study type: Interventional

This study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and sitagliptin (a medicine doctors can already prescribe). Participants will either get oral semaglutide or sitagliptin - which treatment is decided by chance. Participants will get 2 tablets a day to take first thing in the morning on an empty stomach. Only 1 tablet has study medicine in it. The other tablet is a dummy medicine (placebo). After taking the semaglutide tablet, participants may not eat or drink anything for at least 30 minutes. After the 30 minutes, participants must take the sitagliptin tablet. Then participants can have their first meal of the day and take any other medicines they may need, including their metformin. The study will last for about 7 months (33 weeks). Participants will have 8 clinic visits and 1 phone call with the study doctor. At all 8 of the clinic visits, participants will have blood samples taken.

NCT ID: NCT04017221 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety of Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors Among Patients With Type 2 Diabetes

Start date: October 1, 2018
Phase:
Study type: Observational

The purpose of this study is to compare the risk of serious adverse events associated with the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in comparison with the use of dipeptidyl peptidase-4 (DPP-4) inhibitors among patients with type 2 diabetes. More specifically, the investigators will assess the risk of severe urinary tract infection (urosepsis), diabetic ketoacidosis and lower extremity amputation. The investigators hypothesize that the use of SGLT2 inhibitors will be associated with an increased risk of serious adverse events in comparison with the use of DPP-4 inhibitors. The investigators will carry out separate population-based cohort studies using health care databases in seven Canadian provinces and the United Kingdom. Separate study cohorts will be created for each of the three safety outcomes. The study cohorts will be defined by the initiation of a SGLT2 inhibitor or a DPP-4 inhibitor after SGLT2 inhibitors entered the market. Patients will be followed up until the occurrence of an adverse event. The results from the separate sites will be combined by meta-analysis to provide an overall assessment of the risk of serious adverse events in users of SGLT2 inhibitors in comparison to users of DPP-4 inhibitors.