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

Overview

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.

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: August 31, 2024

Interventions

• Device: Continuous Glucose Monitor
  • Manufactured by Abbott Diabetes Care Inc. Administered by trained investigator prior to hospital discharge, left in place for 2 weeks duration, then removed.
• Device: Blood Glucose Monitor
  • Self-administered according to investigator instruction.

Arms, Groups and Cohorts

• Experimental: Continuous Glucose Monitoring (CGM)
  • Patients in the CGM group will be instructed to wear a CGM uninterruptedly for 2 weeks duration.
• Active Comparator: Blood Glucose Monitoring (BGM)
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • NYU Langone Health
• Collaborator
  • Abbott Diabetes Care Inc
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Stanislaw Klek, Principal Investigator, NYU Langone Hospital – Long Island
• Overall Contact(s)
  • Stanislaw Klek, 516-663-3511, Stanislaw.Klek@nyulangone.org