About this trial
The proposed study will be a randomized, prospective, non-blinded study of 120 participants with type 1 or type 2 diabetes that are new-to-insulin on hospital discharge. On hospital discharge, participants will be assigned to either the intervention of wearing a continuous glucose monitor (CGM) for 2 weeks or blood glucose monitoring (BGM) for 2 weeks. They will have a 2-week follow up visit, during which insulin doses will be adjusted as needed, and a 3-month follow-up visit, at which point HbA1c will be measured.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female aged 18-100 years
Known history of type 1 or type 2 diabetes
Admitted to NYU Langone Hospital - Long Island between December 16, 2024- December 31, 2026
New initiation of insulin therapy, including basal insulin regimen, basal-bolus insulin regimen, or mixed insulin regimen at the time of hospital discharge
Disqualifiers
Prior to admission use of home insulin therapy
Current use of systemic corticosteroids
Active pregnancy; as pregnancy requires different blood glucose targets, subjects known to be pregnant will be excluded from this study. Subjects will not be tested for pregnancy outside of testing performed in routine medical care; pregnancy will be determined by patient self-reporting. Females of childbearing potential will not be instructed to avoid pregnancy, however if they became pregnant during the study (detected by self-reporting), they will be withdrawn from the study.
Trial design
Parallel
Treatments tested in this trial
Continuous Glucose Monitor
DeviceManufactured by Abbott Diabetes Care Inc. Administered by trained investigator prior to hospital discharge, left in place for 2 weeks duration, then removed.
Blood Glucose Monitor
DeviceSelf-administered according to investigator instruction.
Treatment groups
Trial outcomes
Primary outcomes
Percentage Change in Hemoglobin A1c (HbA1c)
Assessed via CGM or BGM.
Secondary outcomes
Number of Hospital Admissions
Number of Emergency Department (ER) Visits
Number of Hypoglycemic Events
Sponsors and contacts
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