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Recruiting

NCT Number: NCT05548205

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

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.

Recruiting

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States

Location status: Recruiting

Location contact

Michael Goldstein

CONTACT

[email protected]

516-663-3511

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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to avoid pregnancy, however if they became pregnant during the study (detected by self-reporting), they will be withdrawn from the study.

Treatment and study plan

Continuous Glucose Monitor

Device

Manufactured by Abbott Diabetes Care Inc. Administered by trained investigator prior to hospital discharge, left in place for 2 weeks duration, then removed.

Other names: Dexcom G7

Blood Glucose Monitor

Device

Self-administered according to investigator instruction.

Primary outcomes

  1. Percentage Change in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, Month 3 Post-Discharge

    Assessed via CGM or BGM.

Secondary outcomes

  1. Number of Hospital Admissions

    Time frame: Up to Month 3 Post-Discharge

  2. Number of Emergency Department (ER) Visits

    Time frame: Up to Month 3 Post-Discharge

  3. Number of Hypoglycemic Events

    Time frame: Up to Month 3 Post-Discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Goldstein

CONTACT

[email protected]

516-663-3511

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 21, 2022
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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