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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes

Intervention / Treatment
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* Device: Continuous Glucose Monitor
* Device: Blood Glucose Monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 18-100 years Known history of type 1 or type 2 diabetes Admitted to NYU Langone Hospital - Long Island between September 1st, 2022 and August 31st, 2023 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: 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to avoid pregnancy, however if they became pregnant during the study (detected by self-reporting), they will be withdrawn from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Glucose Monitoring (CGM)<br>Patients in the CGM group will be instructed to wear a CGM uninterruptedly for 2 weeks duration. | Device: Continuous Glucose Monitor<br>* Manufactured by Abbott Diabetes Care Inc. Administered by trained investigator prior to hospital discharge, left in place for 2 weeks duration, then removed.<br>* Other names: Freestyle Libre 2;|
| Active Comparator: Blood Glucose Monitoring (BGM)<br>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. | Device: Blood Glucose Monitor<br>* Self-administered according to investigator instruction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change in Hemoglobin A1c (HbA1c) | Assessed via CGM or BGM. | Baseline, Month 3 Post-Discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Hospital Admissions |  | Up to Month 3 Post-Discharge | 
| Number of Emergency Department (ER) Visits |  | Up to Month 3 Post-Discharge | 
| Number of Hypoglycemic Events |  | Up to Month 3 Post-Discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous Glucose Monitoring (CGM)