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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT05262595 Completed - Clinical trials for Diabetes Mellitus, Type 1

A Study to Look at How Insulin NNC0471-0119 Works in the Body in People With Type 1 Diabetes When Injected by Insulin Pump

Start date: March 3, 2022
Phase: Phase 1
Study type: Interventional

This study is looking at the effect and safety of 3 formulations of the new rapid-acting insulin analogue NNC0471-0119, for the treatment of type 1 diabetes when given by insulin pump. The study will test how 3 different formulations of insulin NNC0471-0119 are tolerated by the body, how they are transported in participants bloodstream, how long they stay there and how the blood sugar is lowered. The 3 formulations of insulin NNC0471-0119 are given as one bolus on top of a constant insulin basal rate and compared to Faster Aspart (Fiasp®). Participants will get 3 formulations of insulin NNC0471-0119 and Faster Aspart (Fiasp®) Insulin NNC0471-0119 is a new rapid-acting insulin designed to be used in an insulin pump. Faster Aspart (Fiasp®) is a globally used medication for the treatment of diabetes. Participants will have each study medicine administered once via pump at separate study visits. This mean that participants will have a total of 4 dosing visits where participants will get a study medicine. Which study medicine participants get at what visit will be decided by chance. The study will last 1-4 months. Participants will have 7 visits at the clinic, 4 of them will require an in-house stay of 3 consecutive days each. During the in-house visits 2 intravenous (into the vein) cannulas will be inserted for blood sampling and infusions. Women: Women cannot take part if they are of childbearing potential.

NCT ID: NCT05262387 Completed - Clinical trials for Diabetes Mellitus, Type 1

A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes

Start date: February 14, 2022
Phase: Phase 1
Study type: Interventional

This study will be conducted in participants with type 1 diabetes mellitus on continuous subcutaneous insulin infusion (CSII) or pump therapy to evaluate the effect of LY900014 (Lyumjev) on blood sugar levels during exercise using different approaches on basal rate reduction and following a test meal compared to insulin lispro (Humalog). The study may last up to approximately 10 weeks and may include up to 7 visits.

NCT ID: NCT05260983 Completed - Clinical trials for Diabetes Mellitus, Type 2

Acceptance and Commitment Therapy Principles for Diabetes Prevention

Start date: August 28, 2021
Phase: N/A
Study type: Interventional

The investigators will evaluate whether a brief intervention (i.e. a workbook and video presenting educational information and activities materials for diabetes prevention) that incorporates principles drawn from focused Acceptance and Commitment Therapy frameworks impact positive and negative affect, stress perceptions, treatment expectations and intentions to engage, motivation and activation, illness perceptions, stress, diabetes distress, weight stigma internalization, controllability awareness, psychological flexibility, and self-efficacy - compared to standard diabetes prevention education materials.

NCT ID: NCT05260879 Completed - Clinical trials for Diabetes Mellitus, Type 2

Potential Effectiveness of the Diabetes Prevention Program in the Peri-urban Area of Bamako, Mali

PPD-Mali
Start date: November 26, 2021
Phase: N/A
Study type: Interventional

The proposed research is an innovative adaptation of the Centers for Disease Control and Prevention's (CDC) Diabetes Prevention Program "Power to Prevent" program, which will be developed and piloted in the low-income peri-urban neighborhoods of Bamako, Mali. This program is well-suited to delivery by the city's community health workers already supporting families in improving maternal and child health outcomes. First, it will use participatory research methods to engage them and community residents in making adaptations to the community health worker's guidelines and tools for recommended activities so that they are linguistically and culturally appropriate, including guidelines for food consumption using locally available foods. These adaptations will use more graphics and photographs, so they are appropriate for low-literacy participants. Second, another key innovation is the explicit orientation to couples, where only one may have a diagnosed cardiovascular disease. This adaptation will provide tools the women can use in negotiating for changes to the family's meals and her daily routine. Third, investigators will conduct a comparative effectiveness study at 6 community health centers with high rates of Cardiovascular Disease (CVD), recruiting adults recently diagnosed with diabetes or hypertension. Based on the random allocation of their community health center, participants will be assigned to one of three groups of 150 each: Couples, with at least one meeting the eligibility criteria; Individuals, men and women, both eligible; Comparison, men and women with CVD. Trained community health workers and diabetic peer educators will use the adapted Diabetes Prevention Program (DPP) materials with the Couples and Individuals groups over a period of 6 months. At the conclusion of this pilot investigators will assess the levels of adoption of recommended cardiovascular risk reduction behaviors and changes in obesity, hypertension, and diabetes control, comparing differences in outcomes between the three groups. It will enable Mali to incorporate diabetes and hypertension risk reduction into their already deployed networks of community health workers. The Malian DPP adaptation will also be suitable for Francophone West Africa, where customs and lifestyles are similar among the millions of families confronting the burdens of cardiovascular disease.

NCT ID: NCT05259735 Completed - Diabetes Clinical Trials

A Clinical Guideline-based Management of Type-2 Diabetes by Ayurvedic Practitioners in Nepal

Start date: July 17, 2022
Phase: N/A
Study type: Interventional

T2DM is a complex disorder which has major health, social and economic consequences. Its chronic hyperglycaemia is associated with macro- and micro-vascular complications and even death. The prevalence of T2DM in Nepal is high. In Nepal, Ayurveda is the dominant traditional medical system and is in use for thousands of years, especially for meeting the primary healthcare needs. Lack of availability of western medical system doctors in rural areas is another reason. In recognition of these facts, the Nepalese government actively promotes Ayurveda and deploys Ayurvedic practitioners in PHCs, often as the main clinical provider. This is a two-arm, feasibility cluster RCT with blinded outcome assessment and integrated qualitative process evaluation will be conducted in 12 Ayurvedic Primary Health Care Center Participants who are aged 18 years or above, new T2DM patients (i.e., treatment naïve), diagnosed by the participating Ayurvedic practitioner and able to provide written informed consent will be enrolled in the study. Each participant will be involved in the study for six months. Patient will be assessed for Glycated haemoglobin, Lipid Profile, Physiological parameters like heart rate and pulse rate, Anthropometric parameters, EuroQol-5D-5L

NCT ID: NCT05259033 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Semaglutide (COMBINE 2)

COMBINE 2
Start date: April 11, 2022
Phase: Phase 3
Study type: Interventional

This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to semaglutide taken once a week in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to semaglutide. Participants will either get IcoSema or semaglutide. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe semaglutide in many countries. Participants will get IcoSema or semaglutide, which they must inject once a week with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will have 18 clinic visits, 34 phone/video calls with the study doctor, and 4 contacts with the site that can either be clinic visits or phone/video calls. At 11 clinic visits participants will have blood samples taken. At 7 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

NCT ID: NCT05258630 Completed - Clinical trials for Diabetes Mellitus, Type 2

Diabetes Homeless Medication Support

D-HOMES
Start date: February 23, 2022
Phase: Phase 2
Study type: Interventional

This randomized pilot trial of the Diabetes Homeless Medication Support intervention vs. brief diabetes education will test the perception and feasibility of anticipated study procedures and refine randomization and blinding.

NCT ID: NCT05257564 Completed - Diabetes Mellitus Clinical Trials

Cardiometabolic Devices Accuracy Study

Start date: February 14, 2022
Phase: N/A
Study type: Interventional

With the rise of cardiovascular diseases (CVD) and diabetes, the global disease burden is shifting towards non-communicable diseases (NCDs). An increasing number of low- and middle-income countries (LMICs) are currently experiencing the double burden of infectious and non-communicable diseases. In order to facilitate a patient-centred approach to healthcare, there is an urgent need to ensure that primary healthcare (PHC) facilities in LMICs are capable of addressing diagnosis and monitoring of non-communicable diseases at the point-of-care (POC). Important minimum parameters for PHC POC diagnosis and monitoring of cardiometabolic diseases are lipids/lipoproteins, glucose, glycated haemoglobin (HbA1c) and serum creatinine, to address cardiovascular disease, diabetes and chronic kidney disease. While several technologies of multi-parameter POC devices capable of supporting diagnosis and monitoring of cardiometabolic diseases exist, their quantitative accuracy is often not well evaluated outside of the manufacturer's laboratories and published independent evaluations can be rare, particularly in the settings of intended use. These settings are PHC facilities in varying climatic environments and with staff without specialist laboratory training. Our study aims to evaluate the quantitative accuracy of 2 cardiometabolic POC devices in a setting of intended use and performed by the intended user. (Evaluating the quantitative measurements of glucose, HbA1c, total cholesterol and creatinine as measured in a healthcare setting with point-of-care multiparameter devices compared to a laboratory reference method).

NCT ID: NCT05256706 Completed - Clinical trials for Diabetes Mellitus, Type 2

SomaSignal Tests on Medical Management and Change in Risk in Patients With Diabetes

Start date: February 3, 2022
Phase: N/A
Study type: Interventional

Despite the development of novel treatments, cardiovascular disease (CVD) remains the leading cause of death and disability. It has been observed in clinical practice, that the use of novel glycemia-lowering therapies with cardioprotective features remains profoundly low despite proven efficacy. It has been proposed that such low uptake is more related to insurance type and coverage than to risk assessment. While it can be easy to blame prescribing deficiencies on complacent physicians and/or over-frugal payors, SomaLogic believes there is more likely to be a fundamental problem with the cost and risk-effective allocation of such therapies, which are neither low in cost nor free of adverse events. As current clinical trials and guidelines tend to "bundle" participants together, there is an absence of individualized assessment of residual cardiovascular risk. This leads to physicians, participants, and payors being relatively uninformed as to the need for and/or likely benefits of such therapies in an individual. Simply giving every eligible participant a drug regardless of residual risk would be unaffordable and would create adverse effects and costs for people at low residual risk who might not actually benefit from the drugs. To resolve this lack of precision in risk assessment, SomaLogic has performed the largest ever proteomic program to date with over 36,000 samples from 26,000 participants in eleven clinical studies, for a total of over 180,000,000 protein measurements, to develop and validate a surrogate proteomic endpoint for cardiovascular outcomes. The SomaSignal Cardiovascular Risk (SSCVR) test, a 27-protein model encompassing ten biological systems.

NCT ID: NCT05256043 Completed - Diabetes Mellitus Clinical Trials

Investigation of Critically Ill Patients With Newly Diagnosed Diabetes

Start date: January 1, 2011
Phase:
Study type: Observational

The purpose of this study is to investigate the clinical outcomes and glucose control metrics of critically ill patients with previously undiagnosed diabetes compared to those with known diabetes at the time of admission to the intensive care unit (ICU).