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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05548205
• Other study ID #: 22-01051
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: Stanislaw Klek
• Phone: 516-663-3511
• Email: Stanislaw.Klek[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes

Intervention

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.
• Blood Glucose Monitor
Self-administered according to investigator instruction.

Locations

Country	Name	City	State
United States	NYU Langone Hospital - Long Island	Mineola	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Abbott Diabetes Care Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change in Hemoglobin A1c (HbA1c)	Assessed via CGM or BGM.	Baseline, Month 3 Post-Discharge
Secondary	Number of Hospital Admissions		Up to Month 3 Post-Discharge
Secondary	Number of Emergency Department (ER) Visits		Up to Month 3 Post-Discharge
Secondary	Number of Hypoglycemic Events		Up to Month 3 Post-Discharge