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

ConditionDiabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNYU Langone Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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to avoid pregnancy, however if they became pregnant during the study (detected by self-reporting), they will be withdrawn from the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Blood Glucose Monitor

    Device

    Self-administered according to investigator instruction.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Continuous Glucose Monitoring (CGM)Experimental treatment 1 intervention
Group B: Blood Glucose Monitoring (BGM)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage Change in Hemoglobin A1c (HbA1c)

Assessed via CGM or BGM.

Time frame
Baseline, Month 3 Post-Discharge

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

Other outcomes

Sponsors and contacts

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