Effect of 2-Week Continuous Glucose Monitoring on Glycemic Management in Patients New-to-Insulin on Hospital Discharge
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous Glucose Monitor, Blood Glucose Monitor.
- Who it may be relevant to
- Registry conditions: Diabetes. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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.
Primary outcome measures
- Percentage Change in Hemoglobin A1c (HbA1c) [Time frame: Baseline, Month 3 Post-Discharge]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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 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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- NYU Langone Hospital - Long Island — Mineola
Identifiers
NCT: NCT05548205 · 22-01051