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Not yet recruitingNCT07221812Updated Apr 29, 2026

Continuous Glucose Monitors (CGMs) and Readmission Rates

An interventional study of Continuous Glucose Monitor and Control Group in Diabetes (DM), sponsored by University of Maryland, Baltimore. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the detailed description

Utilizing CGM devices for patients with diabetes at hospital discharge can be a feasible and easily to implement intervention, improving glycemic control. Compared to Point of Care (POC) glucose testing, CGM devices can provide an easier and painless method for monitoring blood glucose levels. By checking glucose values every couple of minutes, having alarm features and by having the ability to provide remote glucose monitoring (with software applications -smartphones-Bluetooth and internet), CGMs can have many benefits for patients with diabetes following hospital discharge: They can help patients with diabetes and their providers to achieve better glucose control after hospital discharge, reducing hyperglycemia, hypoglycemia and glucose variability, conditions that are associated with adverse outcomes among patients with diabetes. As extreme glucose values (hyperglycemia -hypoglycemia- glucose variability) are more common during illness in patients with diabetes, frequent glucose monitoring by CGMs can help patients as also medical providers to utilize them as another "vital sign", leading to early interventions.

These early interventions can have many other potential beneficial health effects. By monitoring glucose values closely, they can decrease hyperglycemia and hypoglycemia leading to better glucose control, reduced post discharge complications and as a result decrease readmission rates and mortality. Hospital readmissions, especially when they occur during the early period after hospital discharge, represent a marker of poor-quality healthcare delivery and have been associated with increased health care costs. In an effort to reduce readmission rates, the Centers for Medicare and Medicaid Services (CMS) Readmissions Reduction Program penalizes hospitals with high 30-day readmission rates. Among patients, those with diabetes have high readmission rates, ranging between 14% and 26%. This is translated to increased hospital expenses: It has been estimated that the cost of 30-day readmissions for patients with diabetes is nearly $25 billion. In addition, using CGM devices early upon discharge can lead to decreasing Emergency Department (ED) visits and post discharge mortality.

02

Conditions studied

  • Diabetes (DM)

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Keywords

  • Continuous Glucose Monitors
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's planned enrollment of 120 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. ≥18 years of age
  2. 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
  3. Uncontrolled glycemic control, defined as hyperglycemia with HbA1c ≥8%

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Patients at the time of screening on insulin pumps or CGMs
  3. Pregnant patients
  4. Patients with extensive skin disease or allergies that preclude wearing the CGM sensor
  5. Patients without current access of (or who are unable to obtain) a smartphone device and internet
  6. Patients who have end-stage renal disease requiring dialysis
  7. 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
  8. taking hydroxyurea
  9. 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Real time-CGM

    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

  • Other
    Point of Care (POC)

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

    Other: Control Group

Interventions

  • DeviceContinuous Glucose Monitor

    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.

  • OtherControl Group

    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.

06

What researchers measure

Primary outcomes

  1. Change in glycemic control

    HbA1c

    Time frame: 90 days

  2. Change in hypoglycemia events

    Hypoglycemia \< 70 mg/dL

    Time frame: 90 days

  3. Change in Glucose Variability

    Glucose Variability- Coefficient of Variation (CV%)

    Time frame: 90 days

  4. Change in Time In Range (TIR)

    Change TIR (70-180 mg/dL)

    Time frame: 90 days

  5. Change in Glycemic Risk Index (GRI)

    GRI (Hyperglycemia Component/Hypoglycemia Component)

    Time frame: 90 days

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

    Change in Average glucose values (mg/dL)

    Time frame: 90 days

Secondary outcomes

  1. Change in 30-day readmission rates

    Change in readmission rates

    Time frame: 30 days

  2. Change in 60-day readmission rates

    Change in 60-day admission rates

    Time frame: 60 days

  3. Change in 90-day readmission rates

    Change in 90-day readmission

    Time frame: 90 days

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

    Change in ED visits at 30 days

    Time frame: 30 days

  5. Change in ED visits at 60 days

    Change in ED visits at 60 days

    Time frame: 60 days

  6. Change in ED visits at 90 days

    Change in ED visits at 90 days

    Time frame: 90 days

  7. Change in Mortality rates at 30 days

    Change in Mortality rates at 30 days

    Time frame: 30 days

  8. Change in mortality rates at 60 days

    Change in mortality rates at 60 days.

    Time frame: 60 days

  9. Change in mortality rates at 90 days

    Change in mortality rates at 90 days

    Time frame: 90 days

07

Study locations

1 site
  • Baltimore VA Medical Center
    Baltimore, Maryland 21201, United States
08

References and documents

Individual participant data

Plan to share: No — IPD information is not necessary to share our study findings to the sponsor or peer-review organizations

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07221812
Lead sponsor
University of Maryland, Baltimore
Collaborators
DexCom, Inc.
Responsible party
Sponsor
First posted
Oct 28, 2025
Start date
Jun 18, 2026 (estimated)
Primary completion
Jun 17, 2028 (estimated)
Completion
Jun 17, 2028 (estimated)
Last update
Apr 29, 2026

Study contacts

William H Scott, MA
Contact
William.Scott5@va.gov
410 605 7000 ext. 53558
Jade Churchill, BS
Contact
Jade.Churchill@va.gov
410 605 7000 ext. 53595
Ilias Spanakis, MD
principal investigator · Baltimore VA Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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