Clinical Study Details
Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes (CLVer)
The study is being done in children who were recently diagnosed with type 1 diabetes
(T1D). We want to find out if keeping the blood sugar very close to normal will help pancreas cells that make insulin stay alive longer. The study also is testing whether a drug called verapamil can keep these cells healthy.
This is a randomized trial, you can be randomized to one of two groups;
"Usual Care", where you will recieve your care from your endocrinologist with little study intervention. This will include receiving insulin either by injections or with an insulin pump. It also will include using a device called acontinuous glucose monitor or CGM. The CGM has a small needle inserted under theskin. It measures the sugar level every 5 minutes.
"Intensive Care" where you will recieve your care from your endocrinologist as well as intervention from the study. This will take a lot of effort for you. This will include using a device system called a closed loop system. You might have heard of this type of device. It is sometimes called an artificial pancreas or automated insulin delivery system. The closed loop system includes an insulin pump, a CGM, and a computer program. The CGMmeasures your sugar level. It sends this information to the insulin pump. A computer program on the insulin pump decides how much insulin should be given.
In general, to take part in this study, you must:
- Have newly diagnosed type 1 diabetes
- Be at least 7 years old and less than 18 years old have antibodies related to the pancreas in the blood
- Be able to swallow pills
In general, to take part in this study, you must not:
- Take any medication other than insulin to lower blood sugar
- Be using any closed loop system other than one provided by the study
- Be currently taking any steroids by mouth or injection
- Be pregnant, breastfeeding, or plan to become pregnant during the study if you are female
If you're interested in learning more about this study, please reach out to the research coordinator listed on the right. You may also download the consent form, assent form, and any other documents linked on the right.