300,000+ clinical trials. Find the right one.

110 active trials for Type 1 Diabetes Mellitus

Pregnancy Intervention With a Closed-Loop System (PICLS) Study

In pregnancies associated with diabetes, lowering glucose to the recommended targets to prevent adverse health outcomes often leads to significant hypoglycemia. Hybrid closed-loop (HCL) therapy, automated insulin delivery using an insulin pump getting feedback from a continuous glucose monitor (CGM), may improve outcomes. This exploratory, novel pilot feasibility randomized clinical trial will evaluate pregnant women with type 1 diabetes (T1D) on HCL therapy or Sensor-Augmented Pump Therapy (SAPT, non-communicating pump and CGM) from the 2nd trimester, throughout pregnancy, and 4-6 weeks post-partum. Comparisons will be made on safety (Specific Aim [SA] 1), indices of glycemic variability and fear of hypoglycemia (SA 2), and quality of life and device satisfaction (SA 3) between groups. Exploratory SA 4 will compare maternal and fetal outcomes between groups. Safety data will include episodes of severe hypoglycemia requiring 3rd party assistance, diabetic ketoacidosis, and skin reactions. Glycemic control will be measured by CGM time spent in glucose ranges (<63, 63-140, >140 mg/dL) and other measures of glycemic variability. Subjects will fill out surveys (Fear of Hypoglycemia, a quality of life survey, and 2 questionnaires about device satisfaction) at baseline, throughout gestation, and early post-partum. Data on maternal and fetal outcomes will be collected. Findings will reveal the safety profile and glucose control with a novel therapy for pregnant women with type 1 diabetes.

Start: March 2019

Automated Insulin Delivery in Elderly With Type 1 Diabetes (AIDE T1D)

A multi-center, randomized, crossover trial consisting of three sequential 12-week periods, with the HCL feature used during one period, the PLGS feature used during one period and SAP therapy (control) during one period. The crossover trial will be preceded by a run-in phase in which participants will receive training using the study devices (Dexcom G6 and Tandem t:slim X2 pump). After the last crossover period, participants will be given the opportunity to use study devices for an additional 12 weeks to assess preference of system use (PLGS, HCL or SAP) and associated characteristics, durability and safety in a more real-world setting with less frequent study contact.

Start: September 2020

Pivotal Omnipod Horizon™ Automated Glucose Control System

Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 94-day (13-week) hybrid closed-loop phase conducted in an outpatient setting and an optional 12-month extension phase.

Start: December 2019

Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)

The purpose of the study is to conduct a multicenter, randomized effectiveness trial of The 3Ms. The proposed study will use an effectiveness-implementation "Hybrid 1" design. In this design, the primary goal is to determine whether an intervention works in a real-world setting, but the design also answers secondary questions such as the relationship between treatment dose and treatment outcome and what factors affect the actual delivery of the intervention in the clinics (staff burden, workflow interference etc).

Start: September 2017

Safety, Tolerability and Potential Efficacy of AVT001 in Patients With Type 1 Diabetes

This is a double-blind, randomized , placebo-controlled study to evaluate the safety and tolerability of AVT001, and to assess AVT001 as a potential treatment for type 1 diabetes (T1D). The trial will involve approximately 24 new-onset T1D subjects.

Start: June 2019

Investigation of Chronotropic Index, Exercise Capacity in Type 1 Diabetes Mellitus

To investigate whether diabetes affects lung function and exercise capacity and impairs autonomic nervous system.

Start: January 2020

A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation

The Cell Pouch™ is a novel implantable device, that is transplanted with therapeutic cells such as insulin producing islets. This combination product is designed for the treatment of Type 1 Diabetes Mellitus (T1DM) with hypoglycemia unawareness and a history of severe hypoglycemic episodes. Upon implantation, the Cell Pouch™ is designed to form a natural environment, rich in tissue and microvessels for the transplant and function of therapeutic cells. The Cell Pouch™ is designed as a scaffold made of non-degradable polymers, formed into small cylindrical chambers which, when placed in the subcutaneous site, becomes incorporated with tissue and microvessels to the circumference of removable plugs within as early as two weeks as demonstrated in preclinical studies. After the tissue incorporation, the plugs are removed, leaving fully formed tissue chambers with central void spaces for the transplantation of therapeutic cells including Islets of Langerhans (islets). The Cell Pouch™ forms a natural environment, rich in microvessels that allows the transplanted islets to engraft with intravascular microvessels. It is believed this engraftment will enable long-term survival and function of transplanted islets. This study aims to demonstrate the safety and tolerability of islet transplantation into the Cell Pouch™ for the treatment of T1DM in subjects with hypoglycemia unawareness and a history of severe hypoglycemic episodes. The study also aims to establish islet release criteria that accurately characterize the islet product and are predictive of clinical transplant outcomes into the Cell Pouch™, which will be demonstrated through defined efficacy measures.

Start: February 2019

FASter Insulin in Closed-loop Technology in Children

The main objective of this study is to compare 24/7 hybrid closed-loop insulin delivery under free living conditions applying faster insulin aspart (FiAsp) to 24/7 hybrid closed-loop insulin delivery applying standard insulin aspart in very young children with type 1 diabetes. The closed-loop system consists of three components: the continuous glucose monitor (CGM), the insulin pump and a smartphone Application, or App, that translates, in real-time, sensor glucose levels received from the glucose monitoring device and calculates the amount of insulin to be delivered by the coupled insulin pump. This is a double-blind, multi-centre, randomised, crossover design study, involving a run-in period followed by two 8-week study periods during which glucose levels will be controlled by a hybrid closed-loop system using either standard insulin aspart or faster insulin aspart in random order. Participants aged 2-6 years with type 1 diabetes on insulin pump therapy will be recruited through paediatric diabetes outpatient clinics at participating clinical centres. Enrolment will target up to 30 children (aiming for 6-14 participants per centre) to allow for dropouts during run-in. Prior to the use of study devices, participants and parents/guardians will receive appropriate training by the research team on the safe use of the study pump and CGM device, and the hybrid closed-loop insulin delivery system. Parents/guardians at nursey/school may also receive training by the study team if required. Participants will have regular contact with the study team during the study including 24/7 telephone support. Parents/guardians will be asked to complete validated questionnaires at the start and end of the study to assess quality of life measures including sleep. The primary outcome is the between group difference in time spent in target range between 3.9 and 10.0 mmol/l as recorded by CGM during the study. Secondary outcomes are time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Safety evaluation comprises assessment of the frequency and severity of hypoglycaemic episodes and diabetic ketoacidosis (DKA).

Start: March 2021

A Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in Subjects With Type 1 Diabetes (T1DM)

In this trial, the treatment of subjects with type 1 diabetes with M1 Pram P037 as co-formulation of pramlintide and A21G human insulin analogue product will be compared with a current standard treatment, insulin lispro. During a four months treatment period doses in both treatment arms may be adjusted and optimised under outpatient conditions to allow a meaningful comparison of both treatments with respect to their effects on body weight, achievable glycaemic control, safety and tolerability, treatment satisfaction and well-being.

Start: March 2021

Effect of Splitting Mealtime Insulin Doses After Mixed Meals High in Fat and Protein

The current management of type 1 diabetes mellitus (T1DM) depends on the use of intensive insulin therapy - either by insulin pump therapy or multiple daily injection (MDI) therapy - and the use of carbohydrate counting to determine the mealtime bolus insulin dose according the carbohydrate contents of each meal or snack. However, several studies reported that the fat and protein contents of the meals can also affect the postprandial blood glucose levels and result in delayed postprandial hyperglycemia especially after high fat and protein meals. There is no widely accepted regimen to calculate insulin required for the fat and protein contents of meals especially for patients using multiple daily injection regimen. This study aims to find a better method to cover the increased insulin requirements following mixed fat and protein meals. The study will compare the effect of splitting mealtime bolus insulin doses into pre-meal and post-meal portions to the standard regimen which involve giving bolus dose depending on carbohydrate content only with additional correction doses 2 to 3 hours after the meal to compensate for the postprandial hyperglycemia induced by fat and protein content of the meals.

Start: April 2021

Integrating Community Health Workers Into the Care of Children With Type 1 Diabetes

The primary aim of this randomized controlled trial is to determine if the integration of a Community Health Worker into the healthcare team is associated with an improvement in diabetes control in children with type 1 diabetes. The secondary objectives are to determine if utilization of Community Health Workers is also associated with reduced emergency department visits and hospitalizations, improved attendance at outpatient diabetes appointments, and improvements in psychosocial outcomes and diabetes control.

Start: April 2018

Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients

Primary Objective: To demonstrate the noninferiority of insulin glargine 300 U/mL in comparison to insulin degludec 100 U/mL on glycemic control and variability in participants with diabetes mellitus Secondary Objective: To evaluate the glycemic control and variability parameters in each treatment group at Week 12 using Continuous Glucose Monitoring (CGM) To evaluate the safety of insulin glargine 300 U/mL in comparison to insulin degludec 100 U/mL

Start: October 2019

Hypoglycaemia Awareness Restoration Programme

Insulin treatment for type 1 diabetes inevitably carries risk of hypoglycaemia (low blood sugar) which can be severe enough to cause coma, seizure, even death. Being unable to feel when blood glucose is falling, a condition called impaired awareness of hypoglycaemia (IAH), increases risk of severe hypoglycaemia 6-fold. IAH can be reversed and risk of severe hypoglycaemia reduced when people are taught how to adjust their insulin around their life-styles through structured education but problematic hypoglycaemia may persist. Many people with apparently intractable IAH and recurrent severe hypoglycaemia have thoughts about hypoglycaemia that form barriers to their ability to avoid hypoglycaemia. They cannot benefit from conventional treatments to reduce hypoglycaemia. The investigators developed the Hypoglycaemia Awareness Restoration Programme for people with type 1 diabetes and problematic hypoglycaemia despite otherwise optimised self-care (HARPdoc), a novel intervention that combines revision of knowledge about hypoglycaemia avoidance with psychological therapies that directly address unhelpful health beliefs about hypoglycaemia. HARPdoc is delivered over six weeks, by diabetes educators to groups of 6 people. In a pilot study, severe hypoglycaemia was greatly reduced in 23 people with very longstanding IAH and recurrent severe hypoglycaemia. The investigators propose a group-randomised controlled trial of HARPdoc, comparing it to an established educational intervention (Blood Glucose Awareness Training, BGAT) which has also been shown to reduce severe hypoglycaemia. 96 people with type 1 diabetes and problematic hypoglycaemia persisting despite otherwise optimised insulin self-management will be recruited into groups which will be randomised to receive either HARPdoc or BGAT, in 4 centres. The investigators will measure severe hypoglycaemia over two years following courses; hypoglycaemia risk and experience; overall diabetes control and quality of life.

Start: March 2017

Glycemic Profiles And Insulin Delivery Across The Menstrual Cycle In Women With Type 1 Diabetes

This is an observational study. Forty females with type 1 diabetes (age 18-40) using a continuous glucose monitor and an insulin pump will be enrolled for a 3-month data collection. Study participants will include free-cycling females and females following oral contraceptive therapy.

Start: January 2021

CoYoT1 to California

CoYoT1 to California (CTC) was initiated to develop a patient-centered, home telehealth care model for young adults (YA) ages 16-25 with T1D. It is a 2x2 factorial design, 15-month intervention. Eighty participants will be randomized to Standard Care or CoYoT1 Care, which is delivered by telehealth or in-person. CoYoT1 Care is a patient-centered care model that consists of three major components: shared decision making (patient and provider agree upon priorities for the medical visit), autonomy and supportive care (provider training in communication strategies such as motivational interviewing), and goal setting and action planning (provider training to coach YA in setting SMART goals, developing action plans, and designing follow up plans). Additionally, didactic expert-led sessions (Standard Care) or peer-led, YA-driven group sessions (CoYoT1 Care) are included. At the end of the study, a focus group will be completed to assist in determining which features YA felt were critical to their success from the telehealth intervention, group components, and provider behaviors. ***COVID-19 Update: Due to current hospital and clinical policy adaptation for COVID-19, all participants who were randomized into in-person appointments will now receive care via Telehealth. Telehealth has been implemented hospital-wide and will be the temporary delivery of care method during this pandemic. Participants have been notified of this change and given instruction on how to participate in a Telehealth appointment.

Start: January 2019

Metabolic Pathways of GRA in Patients With Type 1 Diabetes

A pilot study for individuals with Type 1 Diabetes who are willing to add a GRA (Glucagon Receptor Antagonist) to their current Diabetes treatment regimen. There will be 10 study visits over the course of approximately 8 weeks, with 4 weeks of once weekly, subcutaneous GRA (REMD-477) injection. Testing includes 2 MRI scans, 2 glucose challenges, and 2 insulin withdrawal challenges along with physical assessments and vitals.

Start: July 2019

A Cognitive Behavioral Therapy (CBT) Intervention to Reduce Fear of Hypoglycemia in Type 1 Diabetes

All persons with type 1 diabetes are at risk for developing hypoglycemia (low blood sugar). This is a life-threatening condition that leads to profound fear of hypoglycemia and reduced quality of life. Fear of hypoglycemia results in glucose fluctuations (from high to low glucose levels). Young adults are particularly at risk because they report high levels of fear of hypoglycemia and poor glucose control. Currently, no diabetes self-management programs specifically address how to cope with fear of hypoglycemia. The investigators propose to pilot test a fear reduction intervention (Fear Reduction Efficacy Evaluation [FREE]) and its effects on fear of hypoglycemia, diabetes self-management, glucose control, and glucose variability.

Start: November 2018

Internet-Based Cognitive Behavioral Therapy for Depressive Symptoms in Adolescents With Type 1 Diabetes Mellitus

This study evaluates the use of an established internet-based cognitive behavioral therapy intervention in a group of adolescents with type 1 diabetes and mild to moderate depressive symptoms. Half of the participants will receive the internet-based intervention while the other half will receive usual care.

Start: December 2020

Prevalence and Incidence of Complications of Type One Diabetes in pUne at a Tertiary Care centRE

Due to early diagnosis (<20yrs of age) of Type 1 Diabetes, patients face longer duration of disease and greater glycemic exposure which makes them more vulnerable towards chronic complications. The aim of this study is to investigate the prevalence and incidence of micro and macro-vascular, pulmonary complications and patterns of growth failure in approximately 500 Type 1 Diabetes patients enrolled at Diabetes Unit, King Edward Memorial Hospital Research Centre. Then follow up of 100 participants who are above 15 years of age at baseline will be done after 2 years to document incidence and progression of complications. This will contribute in assessing the public health burden of complications of Type 1 Diabetes. Factors associated with prevalence of complications will be investigated. This risk factor analysis could aid in further modifying current prevention and treatment recommendations of these complications. Results of this study could modify current clinical practice.

Start: June 2016

Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab

The purpose of this study is to determine whether teplizumab slows the loss of ? cells and preserves ? cell function in children and adolescent 8-17 years old who have been diagnosed with T1D in the previous 6 weeks.. Subjects will receive two courses of either teplizumab or placebo treatment 6 months apart.

Start: April 2019