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Type 1 Diabetes clinical trials

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NCT ID: NCT05977205 Completed - Type 2 Diabetes Clinical Trials

COVID-19 Glycemic Control Study

Start date: May 2, 2020
Phase:
Study type: Observational

Diabetes mellitus is a chronic disease characterized by the inability of the body to maintain normoglycemia. Treatment of diabetes relies mostly on diabetes self-management, requiring a large investment of time and energy on a daily basis. Psychological wellbeing, behavioral patterns and social context play a major role in diabetes self-management and glycemic control. Social isolation behavior (self-quarantining) may impact glycemic control by influencing daily routines, therapy adherence, physical activity, and self-measurement and eating behaviors. Therefore, a period of nationwide self-quarantine, such as during the lockdown issued during the COVID-19 outbreak in the Netherlands, may have a large effect on glycemic control in patients with diabetes. In this observational cross sectional study, we aim to assess the impact of long-term self-quarantine on glycemic control, diabetes self-management and distress in patients with type 1 and type 2 diabetes mellitus. A specific subgroup of patients with T1D are those with complicated diabetes who have received a pancreas or islet transplantation and use immunosuppression, having multiple risk factors for severe COVID-19. The impact of lockdown strategies on mental and physical health is expectedly even greater in patients at even higher risk for severe COVID-19. We therefore additionally investigated differences in behavioral, mental and physical implications of a nationwide lockdown on patients with type 1 diabetes with and without islet or pancreas transplantation. Measurements will be performed during the lockdown period. Patients will be asked to perform a fingerprick HbA1c measurement once, sent back to the LUMC by mail. Data from continuous or flash glucose monitoring devices will be collected according to standard clinical practice. Furthermore, patients will be asked to fill out an online questionnaire once on diabetes self-management behavior, well-being and distress, along with questions about health status, level of education, medication use, employment, social situation and the impact of self-quarantine on daily routines. In this questionnaire, we ask patients to compare certain aspects of their life (e.g. anxiety, stress, weight, physical activity, glycemic control) at the time of the lockdown to before the lockdown. Data on demographics, type of diabetes, weight, BMI and HbA1c prior to the COVID-19 outbreak will be derived from the patient's electronic health file.

NCT ID: NCT05973422 Not yet recruiting - Type 1 Diabetes Clinical Trials

Sigi Insulin Management System - A First-in-Human Study in Adults With Type 1 Diabetes

SigiFIH
Start date: May 31, 2024
Phase: N/A
Study type: Interventional

This early feasibility first-in-human study is a prospective single-arm single-center study of Sigi insulin patch pump. After a 1st day and night under medical surveillance during a hotel stay, Sigi system will be evaluated during 15 days at home in adults with type 1 diabetes.

NCT ID: NCT05969106 Completed - Type 1 Diabetes Clinical Trials

Tandem Control-IQ Evaluation Regarding Glucose Metrics, Sleep, and Health Economics

STARCARE
Start date: January 1, 2020
Phase:
Study type: Observational

To evaluate Tandem Control-IQ compared with rtCGM and insulin pen respectively rtCGM and insulin pump treatment in children and adolescents regarding glucose control, sleep and health economics for 18 months.

NCT ID: NCT05960656 Recruiting - Type 2 Diabetes Clinical Trials

SGLT2 Inhibitors, Ketogenesis, and Ketoacidosis

Start date: October 5, 2023
Phase: Early Phase 1
Study type: Interventional

In this study, we will test the hypothesis that distinct mechanisms account for the SGLT2i-induced stimulation of ketogenesis and lipolysis versus endogenous (hepatic) glucose production in patients with type 2 diabetes (T2D) and type 1 diabetes (T1D), and that the increases in ketone production and lipolysis can be prevented by concomitant administration of the thiazolidinedione pioglitazone. We will conduct five distinct experiments to test this hypothesis in patients with T2D and T1D. STUDY 1: To examine the effect of empagliflozin versus empagliflozin/pancreatic clamp on EGP (6,6, D2-glucose), gluconeogenesis (D2O), lipolysis (U-2H-glycerol), ketogenesis (13C-palmitate conversion to 3-betahydroxybuyrate), and norepinephrine turnover (3H-NE) in type 2 diabetes subjects. STUDY 2. To examine the role of the SNS on the empagliflozin-induced stimulation of EGP, lipolysis, and ketone production in T2D by comparing the effect of empagliflozin versus empagliflozin plus propranolol. STUDY 3. To examine the 2-HIT hypothesis that the SGLT2i-induced stimulation of EGP, lipolysis, and ketone production requires the combination of volume depletion plus insulinopenia in T2D individuals. STUDY 4. To examine whether the empagliflozin-induced stimulation of EGP, lipolysis, and ketone production in T2D individuals can be blocked by pioglitazone (which has direct hepatic and adipose tissue effects). STUDY 5. To examine whether the empagliflozin-induced stimulation of EGP, lipolysis, and ketone production in T1D individuals can be blocked by pioglitazone (which has direct hepatic and adipose tissue effects).

NCT ID: NCT05960565 Recruiting - Type 1 Diabetes Clinical Trials

Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1

Start date: June 20, 2023
Phase: Phase 2
Study type: Interventional

The investigators will study the effect of microdoses of glucagon at the site of subcutaneous insulin injection. The investigators have unpublished data from anesthetized pigs indicating a major enhancement of insulin absorption.

NCT ID: NCT05950477 Recruiting - Type 1 Diabetes Clinical Trials

Evaluation of the Association Between Depression and Glycemic Control in People With Type 1 Diabetes

Start date: June 12, 2023
Phase:
Study type: Observational

Single-center prospective observational pilot study The aim of the study is to evaluate the potential association between the percentage of time spent in the optimal glycemia range and the score obtained in the questionnaires used to screen for depression. The study involves only one visit for each participant. Each participant will be asked to sign the informed consent to the study and, during the visit, the following information will be acquired: parameters, history of diabetes, concomitant diseases and medications, and CGM metrics. The participant will be administered the following questionnaires for the evaluation of depression, patient-reported outcome measure (PROMs) and treatment satisfaction: - Patient Health Questionnaire (PHQ-9) - Center of Epidemiological Studies-Depression Scale (CES-D) - Diabetes Treatment Satisfaction Questionnaire (DTSQ) - Well-Being Index (WHO-5) - Problem Areas In Diabetes (PAID-5) - European Quality of Life, Five Dimension, Five Level (EQ5D5L)

NCT ID: NCT05949281 Recruiting - Clinical trials for Cardiovascular Diseases

Repurposing Colchicine for Reduction of Residual Inflammatory Risk in Type 1 Diabetes

REC1TE
Start date: August 29, 2023
Phase: Phase 2
Study type: Interventional

The aim of this clinical trial is to evaluate if colchicine in addition to standard of care improves markers of inflammation and cardiovascular disease in persons with type 1 diabetes. Participants will be assigned to either 0,5 mg colchicine daily or placebo in a 1:1 ratio for 26 weeks.

NCT ID: NCT05944731 Not yet recruiting - Type 1 Diabetes Clinical Trials

Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in Kenya.

ACCEDE
Start date: February 5, 2024
Phase: N/A
Study type: Interventional

Diabetes mellitus (diabetes) is a chronic condition that represents a major public health and clinical concern. Self-monitoring of blood glucose (SMBG) is a critical part of the care of individuals with diabetes. SMBG entails capillary fingerstick blood glucose testing multiple times per day. Many people with diabetes find this testing painful and cumbersome, often resulting in poor compliance to a glucose self-monitoring schedule. Furthermore, SMBG only provides limited visibility on daily and nightly glucose profiles, meaning that hypo- and hyperglycaemic episodes can be missed or detected with delay. The use of minimally invasive continuous glucose monitoring devices (CGMs) in diabetes management circumvents these challenges as CGMs measure glucose every few minutes over a period of 1-2 weeks through a sensor with a fine needle that is inserted once into a user's arm or abdomen. This enables periodic glucose measurement without repeat finger pricks and provides the user with a detailed glucose profile over the entire wear time of the sensor, thus enabling better adjustment of therapy or behaviour. In populations where CGMs are accessible to people with diabetes as standard of care and without additional cost, many people with type 1 diabetes have switched from SMBG via fingerstick to the use of CGMs permanently, using the devices continuously. This is rarely possibly for people with type 1 diabetes in the public sector in LMICs as CGMs are not provided as standard of care. Little data on effectiveness, feasibility, acceptability, and cost of the use of CGMs in LMIC populations is available to inform clinical models for the integration of CGMs into diabetes management. Furthermore, it has not been investigated if intermittent, as opposed to continuous use of CGMs provides clinical benefit. Intermittent use could be beneficial for people with diabetes who do not have the means to pay for continuous use of CGMs. This study aims to evaluate the effectiveness, feasibility, acceptability, and cost of intermittent and continuous use of CGM among people with type 1 diabetes in Kenya.

NCT ID: NCT05944718 Recruiting - Type 1 Diabetes Clinical Trials

Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in South Africa

ACCEDE
Start date: September 11, 2023
Phase: N/A
Study type: Interventional

Diabetes mellitus (diabetes) is a chronic condition that represents a major public health and clinical concern. Self-monitoring of blood glucose (SMBG) is a critical part of the care of individuals with diabetes. SMBG entails capillary fingerstick blood glucose testing multiple times per day. Many people with diabetes find this testing painful and cumbersome, often resulting in poor compliance to a glucose self-monitoring schedule. Furthermore, SMBG only provides limited visibility on daily and nightly glucose profiles, meaning that hypo- and hyperglycaemic episodes can be missed or detected with delay. The use of minimally invasive continuous glucose monitoring devices (CGMs) in diabetes management circumvents these challenges as CGMs measure glucose every few minutes over a period of 1-2 weeks through a sensor with a fine needle that is inserted once into a user's arm or abdomen. This enables periodic glucose measurement without repeat finger pricks and provides the user with a detailed glucose profile over the entire wear time of the sensor, thus enabling better adjustment of therapy or behaviour. In populations where CGMs are accessible to people with diabetes as standard of care and without additional cost, many people with type 1 diabetes have switched from SMBG via fingerstick to the use of CGMs permanently, using the devices continuously. This is rarely possibly for people with type 1 diabetes in the public sector in LMICs as CGMs are not provided as standard of care. Little data on effectiveness, feasibility, acceptability, and cost of the use of CGMs in LMIC populations is available to inform clinical models for the integration of CGMs into diabetes management. Furthermore, it has not been investigated if intermittent, as opposed to continuous use of CGMs provides clinical benefit. Intermittent use could be beneficial for people with diabetes who do not have the means to pay for continuous use of CGMs. This study aims to evaluate the effectiveness, feasibility, acceptability, and cost of intermittent and continuous use of CGM among people with type 1 diabetes in South Africa.

NCT ID: NCT05936242 Recruiting - Type 1 Diabetes Clinical Trials

Evaluation of Main Determinants of Postprandial Glucose Response in Type 1 Diabetes

IN-DEEP
Start date: May 18, 2021
Phase:
Study type: Observational

The goal of this observational study is to explore inter- and intra-individual determinants of postprandial glucose response in patients with type 1 diabetes using continous glucose monitoring (CGM). A blood glucose sample will be collected during hospital visit. Participants will be asked to: - record a seven-day food diary - complete EPIC food frequency questionnaire - collect a stool sample.