Diabetes
Conditions
Keywords
Continuous Glucose Monitoring (CGM)
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.
Interventions
DEVICEContinuous 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.
DEVICEBlood Glucose Monitor
Self-administered according to investigator instruction.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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to avoid pregnancy, however if they became pregnant during the study (detected by self-reporting), they will be withdrawn from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Hemoglobin A1c (HbA1c) | Baseline, Month 3 Post-Discharge | Assessed via CGM or BGM. |
Secondary
| Measure | 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 |
Countries
United States
Contacts
CONTACTMichael Goldstein
PRINCIPAL_INVESTIGATORMichael Goldstein
NYU Langone Hospital - Long Island
Outcome results
None listed