Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health iā¦ (NCT05653518) | Clinical Trial Compass
RecruitingNot Applicable
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
United States40 participantsStarted 2023-09-09
Plain-language summary
This study will examine the potential cardiovascular effect(s) of artificial pancreas (AP) technology in patients with type 1 diabetes. AP technology is a system of devices that closely mimics the glucose-regulating function of a healthy human pancreas. It includes an insulin pump and a continuous glucose monitor (CGM). In this study, the investigators will research whether improvements in blood glucose levels and blood glucose variability will in turn decrease biomarkers of inflammation and endothelial dysfunction while improving cardiovascular function.
Who can participate
Age range18 Years ā 40 Years
SexALL
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Inclusion criteria
ā. Clinical diagnosis, based on World Health Organization criteria, of type 1 diabetes for at least one year
ā. Currently using insulin for at least six months
ā. Ages 18-ā¤40 years
ā. Hemoglobin A1c \<10.5%
ā. Body mass index 18-30 kg/m2
ā. Blood pressure \<140/90 mmHg
ā. For females, not currently known to be pregnant or breastfeeding
ā. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued
Exclusion criteria
ā. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
ā. Cerebrovascular accident in the 12 months prior to enrollment
ā. Uncontrolled resting arterial hypertension
ā. Conditions that would make use of a CGM difficult (e.g., blindness, severe arthritis, immobility)
ā. Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
ā. Concurrent use of any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, and/or sulfonylureas)