research depends on patient volunteers
There are currently 6,175 clinical trials registered with the National Institutes of Health (NIH) under the category of diabetes. Roughly 4,890 are tied to device, drug or pharmaceutical industry research, completed and ongoing. What we have left are studies related to behavioral science, education, alternative healthcare related to diabetes and studies which having failed, were terminated.
What follows is a list of ongoing diabetes research that deserves attention. Many of these investigations will be familiar, others less so. I tried to restrict the studies only to those that were active or recruiting, facilitated and run by a reliable sponsor or team, initiated at a Phase II level or better and planned or estimated on completing findings before 2014 (although this doesn’t mean publication ready). Two studies didn’t make that criteria for various reasons, but each are noted with an asterisk. One included, the TEDDY study, will not complete until 2023, but it is such a large scale and important piece of research that it should not be left out. This is not intended as a comprehensive list, but should give an idea of where we are today with diabetes research ambitions and aspirations. (www.clinicaltrials.gov was used as the source.)
Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes
Sponsor: NIH
Purpose:
To find out if very tight blood glucose control from the onset of Type 1 Diabetes can preserve beta cell function. Study subjects will be randomly assigned to receive either standard diabetes management or intensive diabetes management, which involves several days of closed loop therapy (artificial pancreas) followed by home use of a continuous glucose monitor and insulin pump.
Ages Eligible: 10-45
Primary Completion Date: May 2013
Study Completion Date: May 2015
Status: Recruiting
Integration of Continuous Glucose Monitoring Into a Bi-Hormonal Closed-Loop Artificial Pancreas for Automated Management Of Type 1 Diabetes (CL2)
Sponsors: Boston University, Massachusetts General Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), JDRF, the Helmsley Charitable Trust
Purpose:
The investigators hypothesize that our closed-loop glucose-control system (artificial pancreas) can provide Blood Glucose (BG) control in subjects with type 1 diabetes using the estimated Blood Glucose signal from a CGM as the input signal to the controller.
Eligible Ages: 12 +
Estimated Primary and Study Completion Date: July 2011
Status: Recruiting
*Parental Management of Young Children’s Diabetes (YCP)
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Purpose:
Recent findings indicate that responsibility for diabetes management falls heavily on mothers. The majority of families do not receive outside child care assistance and report feeling overwhelmed. Parents report high levels of pediatric parenting stress difficulty, as well as moderate symptoms of anxiety. The current study aims to expand such preliminary findings and specifically examine the effects of a newly-developed parenting support program for parents of young children with Type 1 diabetes. It is hypothesized that the children of participating parents will also demonstrate improved quality of life and metabolic control.
Primary Completion Date: November 2012
Study Completion Date: March 2013
Status: Recruiting
Simulated Diabetes Training for Resident Physicians (SDT)
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Purpose:
The objective of this translational research is to study the effect of implementing an innovative simulated diabetes learning intervention within primary care residency programs across the country (US). A prototype of the learning intervention, called SimCare, has demonstrated in a previous randomized trial to improve A1c levels and reduce risky prescribing events in actual patients of practicing physicians. The intervention uses cognitive behavioral learning theory to provide goal-directed feedback to physicians after every encounter over a series of virtual patient-physician encounters. The online intervention is economical, sustainable, and addresses a number of current obstacles to outpatient diabetes training in primary care residency programs.
Primary Completion Date: February 2011
Study Completion Date: September 2011
Status: Not Yet Open
PROCHYMAL® (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM)
Sponsor: Osiris Therapeutics, JDRF
Purpose:
The active ingredient in PROCHYMAL® is adult human mesenchymal stem cells (MSCs). MSCs have been shown to interact with the immune cells in the body, reducing inflammation and assisting in tissue repair. This study will help determine whether MSCs can protect normal pancreatic tissue from autoimmune attack and repair damaged pancreatic tissue, leading to an increase in insulin production and decrease in circulating blood glucose. The characteristics and biologic activity of PROCHYMAL®, along with a good safety profile in human trials to date, suggest that PROCHYMAL® may be a good candidate for addressing Type 1 Diabetes.
Estimated Primary Completion Date: December 2010
Status: Ongoing, not recruiting
TEDDY – The Environmental Determinants of Diabetes in the Young
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Environmental Health Sciences (NIEHS)
Juvenile Diabetes Research Foundation
Centers for Disease Control and Prevention
Purpose:
The long-term goal of the TEDDY study is the identification of infectious agents, dietary factors, or other environmental agents, including psychosocial factors which trigger T1DM in genetically susceptible individuals or which protect against the disease. Identification of such factors will lead to a better understanding of disease pathogenesis and result in new strategies to prevent, delay or reverse T1DM.
Ages Eligible: Up to 4 months
Estimated Study Completion Date: September 2023
Status: Recruiting
*OpT2mise Glucose Control in Type 2 Diabetes Mellitus (DM) With Insulin Pump Therapy
Sponsors: Medtronic
Purpose:
The purpose of this study is to evaluate the comparative effectiveness of insulin pump therapy versus multiple daily injections in insulin-taking type 2 Diabetes Mellitus who are sub optimally controlled with multiple daily injections (MDI).
Ages Eligible: 30-75 years
Estimated Primary Completion Date: December 2012
Estimated Study Completion Date: June 2013
Status: Not yet open
Autologous Bone Marrow Mononuclear Cells Transplantation in Treating Diabetes Patients
Sponsor: Shandong University, China
Purpose:
The study evaluates the safety and efficiency of autologous bone marrow mononuclear cell transplantation in treating patients with type 1 or 2 Diabetes Mellitus. We hypothesize that autologous bone marrow stem cell transplantation will promote β-cells regeneration by directly differentiated from the transplanted BMMCs or stimulated local stem cells regeneration and thus decrease or eliminate the need of exogenous insulin and improve β-cells function.
Ages Eligible: 16 years to 65 years
Estimated Study Completion Date: March 2014
Status: Recruiting
Please leave a comment if you would like to make an addition.
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