TrialWatch April, 2010

Study to Find Out if Intensive Diabetes Clinic and Continuous Glucose Monitors Help Teenagers With Diabetes

ClinicalTrials.gov Identifier: NCT01083433

This study will look at whether intensive diabetes clinic and continuous glucose monitors (CGM) helps teenagers with a baseline A1c of >8.5% improve their diabetes management. The study is based on the idea that although good glucose control is key to preventing complications of type 1 diabetes, tight control is often hard for teenagers to achieve. The study will compare a traditional diabetes care regimen (Group 1), in which patients attend clinic every three months, to two intensive treatment regimens. In one of the intensive regimens (Group 2), patients and parents will attend a diabetes clinic monthly, have separate 30 - minute visits with physicians and diabetes educators, and 45 minute visits with child psychologists over a period of 4 months. During the first session, there will be discussion as to how parents and children may share responsibility with diabetes tasks. During the second session there will be a review of how the shared task plan worked and discussion of problems that may have been encountered. The third session will include working with parents and children on planning for future challenges. The second intensive regimen will include all of the clinic visits mentioned for Group 2, but also have patients wear a CGM 3-5 days a week and spend 30 minutes monthly with a psychology graduate student discussing CGM adherence. The study’s primary outcome is A1c levels, but researchers are also tracking emergency room visits, hospital admissions, and emergency phone calls for ketonuria and hyperglycemia for each patient. The study is enrolling patients ages 10-18 only at the University Case Hospital Medical Center in Cleveland. We think the findings from this trial could provide some very interesting results about the psychology behind diabetes treatment that could have implications outside of just adolescents. While the importance of education is stressed a lot in diabetes, counseling and psychology don’t come to the forefront as often, so we’ll be interested to see how this plays out. --LR

Autologous Dendritic Cell Therapy for Type 1 Diabetes Suppression

ClinicalTrials.gov Identifier: NCT00445913

The primary cause of type 1 diabetes is that a person’s autoimmune system incorrectly attacks the beta (insulin-producing) cells. There have been strong efforts in the diabetes field as of late to find therapies that can stop this inappropriate attack. This small clinical trial (including only about 15 people with established type 1 diabetes) is taking a unique approach to this by attempting to stop some of the signals between cells that activate the autoimmune system in patients with type 1 diabetes. The study will use a type of cell that is very important in immune system activation – the dendritic cell. It has been shown that if dendritic cells don’t express much of molecules called CD40, CD80, and CD86, the number of cells that can tone down the immune attack, the T-regulatory cells, increases. The method used in the trial will essentially feed dendritic cells little pieces of genes, called “oligonucleotides” that prevent the dendritic cells from expressing the molecules discussed above, with the hope that T-regulatory cell numbers will increase and the autoimmune attack will be toned down. This study will look at the safety of patients receiving such dendritic cells, which is a first step for this type of therapy to expand. --LR