Diabetes

Regional Health is involved in diabetes research trials. Below is more information about the purpose and who the physician (principal investigator) is for each trial. For more in-depth information on the research studies, click the blue name which will lead you to the U.S. National Institute of Health website.


GTI1302: Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus

PURPOSE: This is a multicenter, randomized, partial-blinded, five-arm, placebo-controlled study of human plasma-derived alpha1-proteinase inhibitor (alpha1-PI) in children (ages 6-11 years old) and teens/adults (ages 12-35 years old) with new onset Type 1 Diabetes Mellitus (T1DM). The purpose of this study is to evaluate the safety and efficacy of four dosing regimens of human plasma-derived alpha1-PI in T1DM.

To learn more, contact:
Regional Health
Clinical Research

Email: Research

(605) 755-3982

Principal Investigator
Rachel Edelen, MD
Pediatric Endocrinologist

TrialNet Natural History: Natural History Study of the Development of Type 1 Diabetes

PURPOSE: TrialNet is an international network dedicated to the study, prevention, and early treatment of type 1 diabetes. TrialNet sites are located throughout the United States, Canada, Finland, United Kingdom, Italy, Australia, and New Zealand. TrialNet is dedicated to testing new approaches to the prevention of and early intervention for type 1 diabetes.

To learn more, contact:
Regional Health
Clinical Research

Email: Research

(605) 755-3982

Principal Investigator
Rachel Edelen, MD
Pediatric Endocrinologist

TN07: Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus

PURPOSE: Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's ability to produce insulin decreases. There is evidence suggesting that repeated oral administration of an autoantigen (the same protein that the immune system is reacting to) may introduce a protective immunity and cause the immune system to stop its attack. An earlier, large scale study was done to see if oral insulin could delay or prevent the development of Type 1 diabetes in relatives at risk for developing Type 1 diabetes. The overall results showed that for the entire study population, oral insulin did not delay or prevent Type 1 diabetes. However, an analysis that was done after the conclusion of the trial suggested a potential beneficial effect in a subgroup of participants. The participants who seemed to benefit from oral insulin had higher levels of insulin autoantibodies which are directed against insulin itself ( called mIAA). The Type 1 Diabetes TrialNet study group will further explore the potential role of oral insulin to delay or prevent Type 1 diabetes in a similar group of people. The study will also include a secondary group of individuals at different levels of risk than those in the primary cohort to gather information for future studies.

To learn more, contact:
Regional Health
Clinical Research

Email: Research

(605) 755-3982

Principal Investigator
Rachel Edelen, MD
Pediatric Endocrinologist