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

Not Applicable

Recruiting

• Conditions: Diabetes
• Interventions: Device: Continuous Glucose Monitor; Device: Blood Glucose Monitor

• Registration Number: NCT05548205
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-16
• Study First Submitted QC: 2022-09-16
• Study First Posted: 2022-09-21
• Study Start: 2024-12-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 September 1st, 2022 and August 31st, 2023
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to avoid pregnancy, however if they became pregnant during the study (detected by self-reporting), they will be withdrawn from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Glucose Monitoring (CGM)	Continuous Glucose Monitor	Patients in the CGM group will be instructed to wear a CGM uninterruptedly for 2 weeks duration.
Blood Glucose Monitoring (BGM)	Blood Glucose Monitor	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.

Primary Outcome Measures

Name	Time	Method
Percentage Change in Hemoglobin A1c (HbA1c)	Baseline, Month 3 Post-Discharge	Assessed via CGM or BGM.

Secondary Outcome Measures

Name	Time	Method
Number of Hospital Admissions	Up to Month 3 Post-Discharge
Number of Hypoglycemic Events	Up to Month 3 Post-Discharge
Number of Emergency Department (ER) Visits	Up to Month 3 Post-Discharge

Trial Locations

Locations (1)

NYU Langone Hospital - Long Island; 🇺🇸 Mineola, New York, United States