logiover/clinicaltrials-gov-scraper-sample-data huggingface dataset:
Sleep Duration and Glycemic Control in Adolescents With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT04213547
Organization: Children's Hospital of Philadelphia
Status: RECRUITING
Study type: INTERVENTIONAL
Phases: NA
Conditions: Type 2 Diabetes
Interventions: BEHAVIORAL: Loss frame sleep extension intervention
Lead sponsor: Children's Hospital of Philadelphia (OTHER)
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Enrollment: 90 participants
Eligibility: sex ALL, minimum age 12 Years, maximum age 20 Years
Accepts healthy volunteers: no
Start date: 2020-09-16
Completion date: 2026-06-01
Locations:
facility: Children's Hospital of Philadelphia
city: Philadelphia
state: Pennsylvania
country: United States

Summary:
The primary objective is to determine the cross-sectional relationship between sleep duration (as measured by 14 days of actigraphy) and glycemic control in an adolescent Type 2 Diabetes (T2DM) cohort (age 12-20y, n=67). A secondary objective is to determine if a loss-framed incentive for achieving sleep goals can increase sleep duration in 15 adolescent patients diagnosed with T2DM with insufficient sleep. Another secondary objective is to test if increasing sleep duration leads to improved glycemic control in 15 adolescents with T2DM identified in Aim 1 as having \<8 hr sleep/evening. A focus group will be conducted prior to this intervention with patients ineligible for the intervention in order to determine appropriate text messaging.
Phase IV Study of Duodenal Exclusion for the Treatment of Type 2 Diabetes (T2DM)
ClinicalTrials.gov ID: NCT00534547
Organization: Medtronic - MITG
Status: WITHDRAWN
Study type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes
Interventions: PROCEDURE: Duodenal Exclusion
Lead sponsor: Medtronic - MITG (INDUSTRY)
Enrollment: 0 participants
Eligibility: sex ALL, minimum age 20 Years, maximum age 50 Years
Accepts healthy volunteers: no
Locations:

Summary:
The purpose of this study is to investigate the role of an experimental surgery that may offer better short and long-term control of T2DM in select patients who have not achieved adequate blood sugar control with regular means.
A Phase 1 Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of GL0034
ClinicalTrials.gov ID: NCT07385547
Organization: Sun Pharmaceutical Industries Limited
Status: RECRUITING
Study type: INTERVENTIONAL
Phases: PHASE1
Conditions: Type II Diabetes Mellitus
Interventions: DRUG: GL0034
Lead sponsor: Sun Pharmaceutical Industries Limited (INDUSTRY)
Enrollment: 40 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 80 Years
Accepts healthy volunteers: yes
Start date: 2026-02-25
Completion date: 2026-09-27
Locations:
facility: Syneos Miami
city: Miami
state: Florida
country: United States
facility: Panax Clinical Research
city: Miami Lakes
state: Florida
country: United States
facility: Orlando Clinical Research Center (OCRC)
city: Orlando
state: Florida
country: United States

Summary:
This is an open-label, single-dose, Phase 1 clinical study designed to evaluate the effect of renal impairment on the pharmacokinetics (PK) of GL0034, a long-acting GLP-1 receptor agonist. Approximately 40 adult participants will be enrolled across four groups: normal renal function, moderate renal impairment, severe renal impairment without dialysis, and severe renal impairment with dialysis. Each participant will receive a single subcutaneous dose of GL0034. Blood samples will be collected for PK analysis. Secondary objectives include assessing safety and tolerability. The study will help determine whether renal impairment affects GL0034 exposure and inform dosing recommendations for patients with compromised renal function.
NovoPen®4 Clinical Experience Programme: A Multicentre, Observational Study of NovoPen®4 on Treatment Satisfaction of Insulin Therapy in Type 1 or Type 2 Subjects With Diabetes Mellitus
ClinicalTrials.gov ID: NCT00806858
Organization: Novo Nordisk A/S
Status: COMPLETED
Study type: OBSERVATIONAL
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Delivery Systems
Interventions: DEVICE: NovoPen® 4
Lead sponsor: Novo Nordisk A/S (INDUSTRY)
Enrollment: 526 participants
Eligibility: sex ALL, minimum age , maximum age 
Accepts healthy volunteers: no
Start date: 2008-11
Completion date: 2009-07
Locations:
facility: Novo Nordisk Investigational Site
city: Beijing
state: Beijing Municipality
country: China

Summary:
This study is conducted in Asia. The aim of this observational study is to evaluate subjects' treatment satisfaction and to evaluate subjects' preference of pen device and the incidence of clinical technical complains while using NovoPen® 4 under normal clinical practice conditions.
Improving the Self Management Skills of Older Adults With Diabetes
ClinicalTrials.gov ID: NCT01943357
Organization: Stanford University
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: NA
Conditions: Type 2 Diabetes
Diabetes
Interventions: BEHAVIORAL: Diabetes Self Management Program
Lead sponsor: Stanford University (OTHER)
Collaborators: HealthCore, Inc.
Enrollment: 1000 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 
Accepts healthy volunteers: no
Start date: 2013-09
Completion date: 2017-02
Locations:
facility: Stanford University School of Medicine
city: Stanford
state: California
country: United States

Summary:
The study will help determine if the Better Choices Better Health Diabetes program (community-based or online, also known as the Diabetes Self-Management Program) improves the hbA1C of people with Type-II diabetes. The investigators will also examine 1) symptoms (fatigue, sleep, low blood sugar symptoms, depression, shortness of breath), 2) healthy behaviors (blood sugar monitoring; taking medications as prescribed; getting eye, foot, kidney and cholesterol exams; and activity), 3) the use of health care services. This project is a translational study to demonstrate the effectiveness of the intervention in the context of a major insurer.
PHASE 4 STUDY OT THE EFFECT OF GLUCOSE ADDED TO THE DIALYSIS FLUID ON BLOOD PRESSURE, BLOOD GLUCOSE AND QUALITY OF LIFE IN HEMODIALYSIS PATIENTS.
ClinicalTrials.gov ID: NCT00278057
Organization: Regional Hospital Holstebro
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: PHASE4
Conditions: Hemodialysis
Interventions: DRUG: dialysisis with and without glucose in the dialysis
Lead sponsor: Regional Hospital Holstebro (OTHER)
Enrollment: 55 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 
Accepts healthy volunteers: no
Start date: 2003-05
Completion date: 2003-05
Locations:
facility: Department of Medicine, Holstebro Hospital
city: Holstebro
country: Denmark

Summary:
We wanted to test the hypotheses that blood pressure level was lower, that the variability of blood pressure and blood glucose was reduced, and that quality of life was improved when glucose was added to the dialysis fluid.
Preventing Amputations by Tailored Risk-based Intervention to Optimize Therapy
Acronym: PATRIOT
ClinicalTrials.gov ID: NCT02356757
Organization: VA Office of Research and Development
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes
Foot Ulcer
Interventions: BEHAVIORAL: Personalized Behavioral Intervention
BEHAVIORAL: Current Best Practice
Lead sponsor: VA Office of Research and Development (FED)
Enrollment: 406 participants
Eligibility: sex ALL, minimum age 21 Years, maximum age 
Accepts healthy volunteers: no
Start date: 2015-08-24
Completion date: 2021-09-30
Locations:
facility: Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
city: New York
state: New York
country: United States

Summary:
The PATRIOT study will evaluate a risk-based personalized behavioral intervention to improve foot self-care, self-monitoring, and modifiable risks for amputation such as blood glucose, blood pressure and cholesterol in order to prevent diabetic foot ulcers in patients at higher than normal risk for amputation. This novel intervention aims to improve self-care and early detection of foot abnormalities in at-risk patients with diabetes and poor foot self-care using advanced behavioral approaches to target adherence to multiple health behaviors, including foot self-care, self-monitoring, medication adherence, dietary adherence, and physical activity simultaneously. If this promising behavioral theory-driven approach delivered using common technology (phone) to the patient at home can work in a setting where improvements in foot care are so urgent, it will be an important scientific contribution.
Weekly Subcutaneous Semaglutide as Adjunct to Closed-loop Therapy in Type 1 Diabetes Care: a Double-blind, Cross-over, Randomized Controlled Trial
Acronym: SEMA-AP
ClinicalTrials.gov ID: NCT05205928
Organization: McGill University Health Centre/Research Institute of the McGill University Health Centre
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: PHASE2
PHASE3
Conditions: Type 1 Diabetes
Diabetes Mellitus, Type 1
Interventions: DRUG: Outpatient therapy: 11 weeks of drug therapy with usual treatment + 4 weeks of closed-loop therapy
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre (OTHER)
Enrollment: 28 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 
Accepts healthy volunteers: no
Start date: 2022-10-02
Completion date: 2024-06-30
Locations:
facility: Research Institute of the McGill University Health Centre
city: Montreal
state: Quebec
country: Canada

Summary:
A closed-loop insulin system, also referred to as the "artificial pancreas" (AP), is made up of an insulin pump, a continuous glucose monitor, and an application communicating between the two to adjust insulin administration based on glucose control. This is meant for the treatment of type 1 diabetes. The McGill Artificial Pancreas (MAP) has been used previously in type 1 diabetes with significant benefits. Though prior studies have shown significant benefit with this system, some challenges still exist.

Semaglutide is used in type 2 diabetes and obesity; it is a once-weekly injectable medication that increases levels of a gut hormone called Glucagon-Like Peptide-1, which modifies gastric emptying, suppresses glucagon, and suppresses appetite. Though its use is not approved in type 1 diabetes in North America, it (along with similar drugs) has been used in studies as adjunctive therapy with insulin with benefits on blood sugar control. Similar medications have been used in type 1 diabetes (such as liraglutide and exenatide), but are not as strong in glucose effect even in type 2 diabetes as compared with semaglutide.

The purpose of our study is to see if semaglutide administered weekly at the maximum tolerated dose in those with type 1 diabetes will have improved glucose control (as per time in target range from continuous glucose monitoring data) compared to placebo, while using a closed-loop insulin system.
Effect of Beetroot Juice on Cardiovascular and Autonomic Responses During and After Exercise in Adults With Type 2 Diabetes
Acronym: DiaBEET
ClinicalTrials.gov ID: NCT07560800
Organization: Oxford Brookes University
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phases: NA
Conditions: Type 2 Diabetes Mellitus
Hypertension
Autonomic Nervous System Diseases
Interventions: DIETARY_SUPPLEMENT: Beetroot juice
DIETARY_SUPPLEMENT: Nitrate-depleted Beetroot Juice Placebo
Lead sponsor: Oxford Brookes University (OTHER)
Enrollment: 20 participants
Eligibility: sex ALL, minimum age 40 Years, maximum age 65 Years
Accepts healthy volunteers: no
Start date: 2026-04-02
Completion date: 2026-07-31
Locations:
facility: Clinical Physiology Laboratory, Oxford Brookes University
city: Oxford
state: Oxfordshire
country: United Kingdom

Summary:
This study will investigate whether a single dose of beetroot juice can improve cardiovascular responses and recovery after exercise in adults with Type 2 Diabetes.

Type 2 Diabetes is associated with higher blood pressure, impaired blood vessel function, and reduced autonomic control of the heart, all of which increase cardiovascular risk and may affect how the body responds to and recovers from physical activity. Beetroot juice is naturally rich in dietary nitrate, which is converted in the body into nitric oxide, a molecule that helps blood vessels relax and improve blood flow. While these effects have been demonstrated in healthy individuals, less is known about their impact in people with Type 2 Diabetes.

In this study, approximately 16 to 20 adults aged 40 to 65 years with Type 2 Diabetes will take part. After an online screening and consent process, eligible participants will attend two laboratory visits at Oxford Brookes University. In a randomised, double-blind, placebo-controlled crossover design, participants will receive beetroot juice during one visit and a nitrate-depleted placebo during the other visit.

During each visit, participants will undergo physiological measurements, including blood pressure, heart rate, oxygen saturation, and capillary blood glucose. Participants will then complete a short session of supervised, light-to-moderate cycling exercise. Measurements will continue during the recovery period to assess how quickly the cardiovascular system returns to resting levels.

The main outcomes are systolic blood pressure and heart rate variability during recovery, which reflect cardiovascular regulation and autonomic function. Secondary outcomes include diastolic blood pressure, heart rate, blood glucose, and markers related to nitric oxide availability.

This study may help determine whether a simple, dietary-based intervention such as beetroot juice can support cardiovascular function and improve recovery after exercise in people living with Type 2 Diabetes.
Control-IQ 2.0 Feasibility Study #2: Use of Control-IQ Technology 2.0 in Adults, Children, and Preschoolers With Type 1 Diabetes
ClinicalTrials.gov ID: NCT05683392
Organization: Tandem Diabetes Care, Inc.
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: NA
Conditions: Type 1 Diabetes
Interventions: DEVICE: t:slim X2 insulin pump with Control-IQ technology 2.0
Lead sponsor: Tandem Diabetes Care, Inc. (INDUSTRY)
Enrollment: 72 participants
Eligibility: sex ALL, minimum age 2 Years, maximum age 80 Years
Accepts healthy volunteers: no
Start date: 2023-02-01
Completion date: 2023-12-13
Locations:
facility: Barbara Davis Center (Pediatric Clinic)
city: Aurora
state: Colorado
country: United States
facility: Barbara Davis Center
city: Aurora
state: Colorado
country: United States
facility: Joslin Diabetes Center
city: Boston
state: Massachusetts
country: United States
facility: University of Virginia
city: Charlottesville
state: Virginia
country: United States

Summary:
The goal of this clinical trial is to assess safety of and explore glycemic outcomes with Control-IQ technology 2.0 in adults, children and preschoolers with type 1 diabetes.
Glycemic Observation and Metabolic Outcomes in Mothers and Offspring / Glycemic Profile of Pregnancy Consortium
Acronym: GO MOMs
ClinicalTrials.gov ID: NCT04860336
Organization: Northwestern University
Status: COMPLETED
Study type: OBSERVATIONAL
Conditions: Gestational Diabetes
Pregnancy Related
Interventions: OTHER: Observational
Lead sponsor: Northwestern University (OTHER)
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Yale University
Women and Infants Hospital of Rhode Island
University of Pittsburgh
Massachusetts General Hospital
Tufts Medical Center
Columbia University
Kaiser Permanente
Enrollment: 2179 participants
Eligibility: sex FEMALE, minimum age 18 Years, maximum age 
Accepts healthy volunteers: no
Start date: 2021-04-01
Completion date: 2025-07-18
Locations:
facility: Yale University
city: New Haven
state: Connecticut
country: United States
facility: Kaiser Permanente - Hawaii
city: Honolulu
state: Hawaii
country: United States
facility: Northwestern University
city: Chicago
state: Illinois
country: United States
facility: Tufts Medical Center
city: Boston
state: Massachusetts
country: United States
facility: Massachusetts General Hospital
city: Boston
state: Massachusetts
country: United States
facility: Columbia University
city: New York
state: New York
country: United States
facility: Kaiser Permanente - Northwest
city: Portland
state: Oregon
country: United States
facility: Magee Womens Research Institute & Foundation
city: Pittsburgh
state: Pennsylvania
country: United States
facility: Women and Infants Hospital of Rhode Island
city: Providence
state: Rhode Island
country: United States

Summary:
The overarching goal of Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (GO MOMs) is to perform a comprehensive, longitudinal description of maternal glycemia over the course of pregnancy and to evaluate how glucose levels throughout pregnancy relate to traditional third trimester gestational diabetes mellitus (GDM) screening and perinatal outcomes.
The Effects of Learning Mindfulness Based Stress Reduction on Psychosocial Variables and HbA1c in Adolescents With Type 1 Diabetes
ClinicalTrials.gov ID: NCT03942471
Organization: Duquesne University
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: NA
Conditions: Type 1 Diabetes Mellitus
Interventions: BEHAVIORAL: Mindfulness Based Stress Reduction
Lead sponsor: Duquesne University (OTHER)
Enrollment: 65 participants
Eligibility: sex ALL, minimum age 12 Years, maximum age 19 Years
Accepts healthy volunteers: no
Start date: 2015-10-14
Completion date: 2019-01-05
Locations:

Summary:
Adolescents with Type 1 Diabetes will be invited to the Mindfulness study. They will be randomly assigned to a Control or Active Group. The Active Group will learn Mindfulness Based Stress Reduction (MBSR) through an online website designed to teach the basic principles of MBSR in six week-long modules. They will be measured in three main areas: before learning the intervention, directly after learning it and 3 months after learning it to determine any changes in their Mindful attention awareness, Diabetes Quality of Life and HbA1c. The Control Group will also take the questionnaires at the beginning of the study, 6 weeks after it begins and then 3 months from the beginning to obtain data for all three time points when they have not received access to the modules/intervention.
The Effect of Dietary Nitrate Supplementation on Red Blood Cell Function in Patients with Type 2 Diabetes
ClinicalTrials.gov ID: NCT04917471
Organization: Karolinska Institutet
Status: RECRUITING
Study type: INTERVENTIONAL
Phases: NA
Conditions: Type 2 Diabetes
Interventions: DIETARY_SUPPLEMENT: Beet root juice
DIETARY_SUPPLEMENT: Placebo juice
Lead sponsor: Karolinska Institutet (OTHER)
Enrollment: 20 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 
Accepts healthy volunteers: no
Start date: 2021-06-01
Completion date: 2025-12-31
Locations:
facility: Karolinska Institutet, Karolinska University Hospital
city: Stockholm
country: Sweden

Summary:
To investigate the effect of nitrate supplementation on red blood cell function in patients with type 2 diabetes.