Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes (NCT04233034) | Clinical Trial Compass
CompletedPhase 3
Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes
United States113 participantsStarted 2020-07-09
Plain-language summary
Randomized trial of youth aged 7-\<18 years with newly diagnosed stage 3 type 1 diabetes (T1D) to assess the effect of both (1) near-normalization of glucose concentrations achieved through use of a hybrid closed loop (HCL) system and (2) verapamil on preservation of β-cell function 12 months after diagnosis. Participants with body weight ≥30 kg (Cohort A) will be randomly assigned in a factorial design to (1) HCL plus intensive diabetes management or usual care with no HCL and (2) verapamil or placebo. Participants with body weight \<30 kg (Cohort B) will be randomly assigned 2:1 in a parallel group design to HCL plus intensive diabetes management or to usual care with no HCL.
Who can participate
Age range7 Years – 17 Years
SexALL
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Inclusion criteria
✓. New-onset stage 3 T1D within 21 days of diagnosis (timed from start of insulin therapy), with ability to be randomized within 31 days of diagnosis (time from diagnosis to screening can be longer provided all screening testing can be completed within 31 days of diagnosis)
✓. At least one positive type 1 diabetes auto-antibody
✓. Age 7 - \<18 years at the time of enrollment
✓. Willing to have a parent or legal guardian provide informed consent and child assent
✓. In a female participant with childbearing potential, not currently pregnant and willing to avoid pregnancy and breastfeeding and undergo pregnancy testing throughout the study
✓. English speaking/reading
✓. Able to swallow pills (tested with an inert imitation tablet in clinic prior to randomization)
✓. Willing to not use any non-insulin glucose-lowering agents
. Ongoing use of medications known to influence glucose tolerance such as systemic steroids
✕. Other systemic disease which in the opinion of the investigator precludes participation (including psychiatric illness)
✕. Unwilling to abstain from use of HCL therapy for 12 months
✕. "Silent" diabetes-i.e., Stage 3 diabetes that is identified by routine oral glucose tolerance testing (OGTT) or in the course of surveillance studies but is not accompanied by fasting hyperglycemia or classic symptoms of diabetes
✕. Participation in another research study that involves diabetes care
✕. Blood pressure (either systolic or diastolic) \<5th percentile for age, gender, and height on two out of three measurements
✕. Pulse \<2nd percentile for age and gender on two out of three measurements
✕. History of vasovagal syncopal episodes related to hypotension