Continuous Glucose Monitors (CGMs) and Readmission Rates

NCT07221812 | Not Yet Recruiting FDA Device

• 1 other identifier: HP-00116128
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Among the diffident groups of patients, those with chronic and severe medical conditions are more likely to be readmitted to the hospital. It is not surprising therefore that patients with diabetes have high readmission rates. Patients with diabetes have 40% higher re-hospitalization rates compared with those patients without diabetes, with 30-day readmission rates reported to range between 14% and 26%. It should be noted that almost 30% of the patients with diabetes are experiencing two or more hospital admissions per year, accounting for more than 50% of total hospitalizations and hospital health care costs. This research application will evaluate whether the initiation of Continuous Glucose Monitor (CGM) devices at the time of hospital discharge will lead to better glucose control and health outcomes compared to the use of "finger sticks" Point of Care (POC) following hospital discharge among patients with diabetes. This study will be a two arm (Real Time CGM vs POC) single center RCT at the Baltimore VA Medical Center. One hundred and twenty individuals will be recruited and randomly assigned (1:1) to either Real Time CGM or to POC following hospital discharge. All subjects will be followed from for 3 months post hospital discharge.

Conditions

Diabetes (DM)

Keywords

Continuous Glucose Monitors

Outcome Measures

Primary Outcomes (6)

• Change in glycemic control

  HbA1c

  90 days

• Change in hypoglycemia events

  Hypoglycemia \< 70 mg/dL

  90 days

• Change in Glucose Variability

  Glucose Variability- Coefficient of Variation (CV%)

  90 days

• Change in Time In Range (TIR)

  Change TIR (70-180 mg/dL)

  90 days

• Change in Glycemic Risk Index (GRI)

  GRI (Hyperglycemia Component/Hypoglycemia Component)

  90 days

• Change in average glucose values at 90 days post discharge.

  Change in Average glucose values (mg/dL)

  90 days

Secondary Outcomes (9)

• Change in 30-day readmission rates

  30 days

• Change in 60-day readmission rates

  60 days

• Change in 90-day readmission rates

  90 days

• Change in Emergency Department (ED) visits at 30-days

  30 days

• Change in ED visits at 60 days

  60 days

Study Arms (2)

Real time-CGM

EXPERIMENTAL

The Real Time-CGM Group will wear the Dexcom G7 CGM device. Their glucose data will be shared in real-time to health care providers for subsequent treatment decisions.

Device: Continuous Glucose Monitor

Point of Care (POC)

OTHER

The Point of Care (POC) group will use "finger sticks" to assess blood glucose values.

Other: Control Group

Interventions

Continuous Glucose Monitor DEVICE

The Dexcom G7 (real-time data) will be placed on all individuals randomized to the Intervention group. Their data will be shared with health care providers using a CGM software application. Providers will use this information during scheduled contact visits to make treatment decisions.

Real time-CGM

Control Group OTHER

The control group will use "finger sticks", usual Point of Care (POC), to measure blood glucose values. This information will be shared with providers and used for all treatment decisions at scheduled visits.

Point of Care (POC)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• Patients with diabetes who are anticipated to be treated with any type of insulin after hospital discharge and with or without non-insulin medications (excluding those who are expected to be treated with correctional-sliding scale insulin regimens only
• Uncontrolled glycemic control, defined as hyperglycemia with HbA1c ≥8%

You may not qualify if:

• Patients with diabetes who are anticipated to be treated with diet only, any combination of non-insulin antidiabetic drugs only, sliding scale correctional insulins (with or without non-insulin medications) after hospital discharge.
• Patients at the time of screening on insulin pumps or CGMs
• Pregnant patients
• Patients with extensive skin disease or allergies that preclude wearing the CGM sensor
• Patients without current access of (or who are unable to obtain) a smartphone device and internet
• Patients who have end-stage renal disease requiring dialysis
• Patients with significant psychiatric illness or any other condition which by investigator decision makes the subject incapable of understanding the objectives and potential consequences of the study
• taking hydroxyurea
• Employed by, or having immediate family members employed by Dexcom, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ilias Spanakis, MD

  Baltimore VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William H Scott, MA

CONTACT

410 605 7000; William.Scott5@va.gov

Jade Churchill, BS

CONTACT

410 605 7000; Jade.Churchill@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2025
• First Posted: October 28, 2025
• Study Start (Estimated): June 18, 2026
• Primary Completion (Estimated): June 17, 2028
• Study Completion (Estimated): June 17, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)