Effect of 2-Week Continuous Glucose Monitoring on Glycemic Management in Patients New-to-Insulin on Hospital Discharge

NYU Langone Health

Status: Enrolling

Conditions: Diabetes

Treatments: Device: Blood Glucose Monitor; Device: Continuous Glucose Monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT05548205

22-01051

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female aged 18-100 years
2. Known history of type 1 or type 2 diabetes
3. Admitted to NYU Langone Hospital - Long Island between December 16, 2024- December 31, 2026
4. New initiation of insulin therapy, including basal insulin regimen, basal-bolus insulin regimen, or mixed insulin regimen at the time of hospital discharge

Exclusion criteria

1. Prior to admission use of home insulin therapy
2. Current use of systemic corticosteroids
3. 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to avoid pregnancy, however if they became pregnant during the study (detected by self-reporting), they will be withdrawn from the study.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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Continuous Glucose Monitoring (CGM)

Experimental group

Description:

Patients in the CGM group will be instructed to wear a CGM uninterruptedly for 2 weeks duration.

Treatment:

Device: Continuous Glucose Monitor

Blood Glucose Monitoring (BGM)

Active Comparator group

Description:

Patients in the BGM group will be instructed to check their blood glucose utilizing fingerstick glucose monitoring multiple times daily depending on their insulin regimen for 2 weeks duration.

Treatment:

Device: Blood Glucose Monitor