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Hypoglycemia clinical trials

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NCT ID: NCT05933161 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Study of Glycemic Control in Left Ventricular Assist

GLYCEM1C-LVAD
Start date: November 10, 2023
Phase:
Study type: Observational

The study is being conducted to understand if the hemoglobin A1c, a measurement of control of blood sugars over a 3-month time, is valid in patients with Left Ventricular Assist Devices (LVADs) in place. To understand whether it is an adequate measurement, the investigators will compare the A1c to results from a continuous glucose monitor (CGM) measurement of blood sugars. By monitoring blood sugars continuously, the investigators will also assess whether they can get better control of blood sugars with a CGM, including avoiding low blood sugars.

NCT ID: NCT05928390 Recruiting - Clinical trials for Post-Bariatric Hypoglycemia

Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia

PASIPHY
Start date: January 4, 2024
Phase: Phase 2
Study type: Interventional

The Total duration of trial participation for each participant with post-bariatric hypoglycemia will be a maximum of 59 weeks, with the following duration of trial periods - 19 weeks for the Core Phase. It is composed of: - a Screening period: a maximum of 3 weeks - a Run-in period (no treatment): 4 weeks - a Blinded Treatment Phase: 12 weeks - 36 weeks Extension Phase = an open-label Treatment period - 4 weeks for the safety follow-up period (without any treatment).

NCT ID: NCT05919927 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

Diabetes and Cognitive Functions in Middle Age

DBC
Start date: June 7, 2018
Phase:
Study type: Observational

This study will examine the effects of type II diabetes on cognitive functions and mood in middle-aged patients. In addition, the association between cognitive functions and glycemic controls is studied in patients. Sixty patients and sixty healthy controls will be recruited and assessed by a multiprofessional team (neuropsychologist, physician).

NCT ID: NCT05916131 Recruiting - Type 1 Diabetes Clinical Trials

Pilot Feasibility Study for HypoPals, a Mobile Health Program for Improving Hypoglycemia Management.

Start date: September 19, 2023
Phase: N/A
Study type: Interventional

A mobile health program "HypoPals", which incorporates data from continuous glucose monitoring systems (CGMs) and sends personalized text messages to help people sharpen their low blood sugar symptom detection skills, and help people consider how they think of low blood sugar, was devised. The goal of the current study is to make sure that HypoPals runs smoothly, users find the intervention useful, and the way the researchers conduct the final study will be correct (i.e., there is a need for 'pilot testing' the developed technology and research methods). All participants will receive basic hypoglycemia education text messages, and then be randomized to one of the four experimental conditions: Hypoglycemia Symptom Detection Training, Education Plus, both Symptom Detection Training and Education Plus, and usual care. Participants may receive additional interventional text messages based on the experimental condition participants are assigned to. The study may terminate after collecting sufficient data to evaluate the primary outcome (i.e., determining the number of participants recruited to reach 20 participants who complete the intervention).

NCT ID: NCT05902104 Recruiting - Hyperglycemia Clinical Trials

CGM-Assisted Management of PN

CAMP
Start date: July 6, 2023
Phase:
Study type: Observational

The purpose of this study is to learn more about changes in glucose levels in hospitalized infants with intestinal failure receiving parenteral nutrition or PN (nutrients delivered intravenously), as they transition from continuous PN (given 24 hours a day) to cycled PN (given less than 24 hours a day). There is an increased risk of glucose abnormalities with cycled PN, which can be harmful to infant growth and brain health. Continuous glucose monitors (CGM) will be used to measure interstitial glucose levels (in the tissue under the skin), which are similar to blood glucose levels. CGM is a small, minimally-invasive sensor worn on the thigh, which gives a glucose measurement every 5 minutes, and can help us understand changes in blood sugar levels without having to do a blood draw or fingerstick. CGM will be used during PN cycling for up to 30 days or until hospital discharge. If target GIR cycled PN is not reached following 3 sensor periods (up to 10 days per sensor), the parent/guardian will be approached to accept or decline participation in an optional extension phase. In the extension phase, the primary study will be repeated and CGM monitoring will continue until target GIR cycled PN is reached, up to an additional 3 sensor placements. CGM data will be hidden from the clinical team, there will be no change to routine clinical care. This study may help us understand how cycled PN affects glucose levels in infants with intestinal failure, which may help other children treated with cycled PN in the future.

NCT ID: NCT05870280 Not yet recruiting - Diabetes Mellitus Clinical Trials

Nurse Coaching the Effect of on Glycemic Control, Fear of Hypoglycemia and Risk Perception in Adults With Type 1 Diabetes.

Start date: August 30, 2023
Phase: N/A
Study type: Interventional

Because of the unforeseen rate of increase in case numbers, the high rates of mortality and morbidity, and the increased socio economic load it causes, diabetes has become the most discussed chronic and widespread metabolic disease in Turkey, and throughout the World, there are focused efforts to find a solution. It is very important for a person to self-assesss and evaluate to draw a roadmap for improved outcomes in a disease with a high financial and moral burden. A nurse is not only a caregiver to patients, but also a person who guides them to increased engagement and motivation in the care of their illness. Integrative Nurse Coaching is gaining notoriaty as an effective method to improve patient engagament and motivation in self-responsibility for health. The Integrative Nurse Coach Academy in the USA carries out studies and trainings to further this improvement. With cooperation between United States and Turkish nurse colleagues, it aims to bring Integrative Nurse Coach practice to Turkey. The Integrative Nurse Coach uses the nursing process as a framework to guide nurse coaching practice. This requires a shift in traditional nursing terminology and meaning to understand and incorporate the patient's subjective experience as follows: from assessment to stablishing a relationship, identifying readiness for change and the resources available to the patient for change; from nursing diagnosis to identifying opportunities and issues; from outcomes to having the patient set the agenda for achievement of the patient's goals; from 3 planning to creating the structure of the coaching interaction; from intervention to empowering the patient to reach goals; and from evaluating to assisting the patient to determine the extent to which goals were achieved. The Theory of Integrative Nurse Coaching (TINC) , developed by the Integrative Nurse Coach Association , sheds light on this point. The TINC encompasses many holistic nursing theories and contains three concepts and five components. The three concepts are healing, metaparadigm in nursing theory (nurse, person, health, environment), and patterns of knowing in nursing (personal, empirics, aesthetics, ethical, not knowing, sociopolitical. The TINC five components include Integrative Nurse Coach Self-Development (self-reflection, self-assessment, self-evaluation self-care), Integral Perspective and Change, Integrative Lifestyle Health and Well-Being, Awareness and Choice, and Listening With Heart The five components all have equal value and form the basis for the nurse coach professional practice model. There is a parallel process of self-development for both the nurse coach and the client. The SelfDevelopment component empowers individuals (including the nurse coach) to focus on their health and wellness from an integral perspective and to identify their individual knowledge, expertise, strengths, and resources, while recognizing the fluidity of the change. The TINC is designed to guide nurse coaching practice, education, research, and health care policy. The theory emphasizes, describes, and directs the practice of nurse coaching, a recognized holistic nursing modality. It has been seen that the TINC framework is very suitable for individuals with diabetes to provide their own management.

NCT ID: NCT05822232 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

FreeStyle Libre 2 Discharge Trial

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

The goal of this clinical trial is to learn about the benefits of using aa Continuous Glucose Monitoring (CGM) system in patients with diabetes following discharge from the hospital. The main question it aims to answer is: • If the use of CGM with alarms is safe and effective for managing low and/or high blood sugars when compared with performing finger sticks several times per day Participants will wear one or two FreeStyle Libre CGM sensors for 12-14 days three times over a 12-week (3 month) period. This means that they will have the one to two sensors inserted under their skin. They will be asked to come to the study site four times and complete two phone calls with research staff over the 12-week period. Researchers will compare the LibreView CGM group to the Standard of Care group to see if the use of continuous glucose monitoring (CGM) reduces risk of low blood sugar in patients with type 2 diabetes (T2D) after hospital discharge when compared with the current standard method.

NCT ID: NCT05806190 Completed - Clinical trials for Diabetes Mellitus, Type 1

Hypoglycaemia (Low Blood Sugar) in Adults With Diabetes and Adrenal Failure

HYPO-DIAD
Start date: April 17, 2023
Phase:
Study type: Observational

The purpose of this study is to measure how often low blood sugars occur in people who live with both adrenal insufficiency (AI) and diabetes and need to take insulin. People who live with AI need to take steroid replacement tablets every day, for life. Two of the most common types of steroid replacement tablets are called prednisolone and hydrocortisone. Low blood sugar (hypoglycemia) is a very common side effect of taking insulin and can often be unpleasant, frightening and dangerous. People who have adrenal failure are also at risk of hypoglycaemia, although this is rare. It is not known whether taking steroids affects how often hypoglycaemia happens. The study has three aims: 1. To measure how often low blood sugars occur at night in people who live with with both adrenal insufficiency (AI) and insulin-treated diabetes 2. To compare how often low blood sugars occur in people taking prednisolone for their AI versus those taking hydrocortisone. 3. To compare the patterns throughout the day for low blood sugars in those taking prednisolone versus those taking hydrocortisone. The study will compare this information with results in people who have AI without diabetes. Participants will be given continuous glucose monitoring systems (Dexcom G6 devices) which are small wearable devices that measure glucose levels throughout the day and night. They will be asked to wear a device for 30 days. Participants will not be asked to make any changes to their usual medications or their diet.

NCT ID: NCT05775770 Recruiting - Hyperglycemia Clinical Trials

Blood Glucose Management in Intensive Care Units

GINGER
Start date: March 20, 2023
Phase:
Study type: Observational

The investigators propose to conduct a study of practices to describe the methods of managing glycemic control in hospitalized patients in critical care. This is a prospective multicenter observational study conducted in Intensive Medicine and Resuscitation departments in France and Belgium. The aim of this study is to carry out an inventory of the current practices of glycemia management as well as their modalities. Being one of the key points of the management, this work will have for main objective to raise the importance of the glycemic variabilities according to the methods of insulin therapies used.

NCT ID: NCT05767255 Recruiting - Clinical trials for Diabetes Mellitus, Type 2 Treated With Insulin

Risk of Hypoglycemia in the Transition From Inpatient to Outpatient Setting. Comparative Study of Basal-bolus Insulin Versus Basal Insulin Plus GLP-1 Analogue

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

The association of insulin degludec with liraglutide in the same device (IDegLira) is a potent but at the same time safe drug that reduces the risk of hypoglycemia when compared to a basal or basal-bolus insulin schedule. The DUAL (Dual Action of Liraglutide and Insulin Degludec) studies are the pivotal studies of this combination. Specifically, the DUAL VII study has demonstrated that ideglira is a non-inferior drug in terms of glycemic control versus a basal-bolus schedule in patients in the outpatient setting who have failed basal insulin. Although the basal-bolus insulin plus correction schedule is frequently used in hospitalized patients with hyperglycemia, outpatient management with a complex insulin schedule creates challenges that are difficult to mitigate due to limited time for patient education during an acute illness and limited access to the physician responsible for post-discharge diabetes management. The use of IDegLira has not been evaluated in clinical studies in the hospital discharge setting where the authors believe it has great potential because it offers similar potency to the basal-bolus scheme but with greater safety with respect to hypoglycemia and less complexity for the patient because it is associated with fewer applications and less need for capillary self-monitoring. For this reason, in the hospital-home transition scenario, ideglira therapy in patients with poor metabolic control and requiring intensification therapy is proposed as an alternative to the basal-bolus scheme.