Effect of 2-Week Continuous Glucose Monitoring on Glycemic Management in Patients New-to-Insulin on Hospital Discharge
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes
Started Dec 2024
Typical duration for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2022
CompletedFirst Posted
Study publicly available on registry
September 21, 2022
CompletedStudy Start
First participant enrolled
December 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
October 2, 2025
September 1, 2025
2 years
September 16, 2022
September 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage Change in Hemoglobin A1c (HbA1c)
Assessed via CGM or BGM.
Baseline, Month 3 Post-Discharge
Secondary Outcomes (3)
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
Study Arms (2)
Continuous Glucose Monitoring (CGM)
EXPERIMENTALPatients in the CGM group will be instructed to wear a CGM uninterruptedly for 2 weeks duration.
Blood Glucose Monitoring (BGM)
ACTIVE COMPARATORPatients 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.
Interventions
Manufactured by Abbott Diabetes Care Inc. Administered by trained investigator prior to hospital discharge, left in place for 2 weeks duration, then removed.
Self-administered according to investigator instruction.
Eligibility Criteria
You may qualify if:
- Male or female aged 18-100 years
- Known history of type 1 or type 2 diabetes
- Admitted to NYU Langone Hospital - Long Island between December 16, 2024- December 31, 2026
- New initiation of insulin therapy, including basal insulin regimen, basal-bolus insulin regimen, or mixed insulin regimen at the time of hospital discharge
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Hospital - Long Island
Mineola, New York, 11501, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Goldstein
NYU Langone Hospital - Long Island
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2022
First Posted
September 21, 2022
Study Start
December 16, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
April 30, 2027
Last Updated
October 2, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- Requests should be directed to Stanislaw.Klek@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Stanislaw Klek (Stanislaw.Klek@nyulangone.org). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.