Diabetes (DM)NCT07221812
Continuous Glucose Monitors (CGMs) and Readmission Rates
A study testing Continuous Glucose Monitor in people with Diabetes (DM), run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes (DM)
- What is being tested?
- Continuous Glucose Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2026to 17 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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%
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Baltimore VA Medical Center
Baltimore, Maryland, 21201
William H Scott, MA, 410-605-7000 ext. 53558, William.Scott5@va.gov
Jade Churchill, BS, 410 605 7000 ext. 53593, Jade.Churchill@va.gov
About this study
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.
- Conditions
- Diabetes (DM)
- Being tested
- Continuous Glucose Monitor, Control Group
- Keywords
- Continuous Glucose Monitors
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose MonitorDevice
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.
Control GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Continuous Glucose Monitor |
| Point of Care (POC) | Other | The Point of Care (POC) group will use "finger sticks" to assess blood glucose values. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycemic control
HbA1c
Measured: 90 days
Change in hypoglycemia events
Hypoglycemia < 70 mg/dL
Measured: 90 days
Change in Glucose Variability
Glucose Variability- Coefficient of Variation (CV%)
Measured: 90 days
Change in Time In Range (TIR)
Change TIR (70-180 mg/dL)
Measured: 90 days
Change in Glycemic Risk Index (GRI)
GRI (Hyperglycemia Component/Hypoglycemia Component)
Measured: 90 days
Change in average glucose values at 90 days post discharge.
Change in Average glucose values (mg/dL)
Measured: 90 days
Secondary outcomes (9)
Change in 30-day readmission rates
Change in readmission rates
Measured: 30 days
Change in 60-day readmission rates
Change in 60-day admission rates
Measured: 60 days
Change in 90-day readmission rates
Change in 90-day readmission
Measured: 90 days
Change in Emergency Department (ED) visits at 30-days
Change in ED visits at 30 days
Measured: 30 days
Change in ED visits at 60 days
Change in ED visits at 60 days
Measured: 60 days
Change in ED visits at 90 days
Change in ED visits at 90 days
Measured: 90 days
Change in Mortality rates at 30 days
Change in Mortality rates at 30 days
Measured: 30 days
Change in mortality rates at 60 days
Change in mortality rates at 60 days.
Measured: 60 days
Change in mortality rates at 90 days
Change in mortality rates at 90 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2025
- Study start18 Jun 2026 (estimated)
- Primary completion17 Jun 2028 (estimated)
- Study completion17 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes (DM)Studies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Sponsor
- Investigators
- Ilias Spanakis, MD, Principal investigator, Baltimore VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221812
- Sponsor's protocol ID
- HP-00116128
- Status last verified
- Apr 2026
- First submitted
- 6 Oct 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD information is not necessary to share our study findings to the sponsor or peer-review organizations
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitors (CGMs) and Readmission Rates
- ClinicalTrials.gov ID
- NCT07221812
- Acronym / sponsor ID
- HP-00116128
- Conditions
- Diabetes (DM)
- Keywords
- Continuous Glucose Monitors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 18 Jun 2026 (estimated)
- Primary completion
- 17 Jun 2028 (estimated)
- Study completion
- 17 Jun 2028 (estimated)
- First posted
- 28 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real time-CGM | Experimental | Device: Continuous Glucose MonitorThe 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. |
| Point of Care (POC) | Other | Other: Control GroupThe Point of Care (POC) group will use "finger sticks" to assess blood glucose values. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥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%
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose MonitorThe 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. | Device | Real time-CGM |
| Control GroupThe 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. | Other | Point of Care (POC) |
Primary outcome
Change in glycemic control
Time frame: 90 days
HbA1c
Change in hypoglycemia events
Time frame: 90 days
Hypoglycemia < 70 mg/dL
Change in Glucose Variability
Time frame: 90 days
Glucose Variability- Coefficient of Variation (CV%)
Change in Time In Range (TIR)
Time frame: 90 days
Change TIR (70-180 mg/dL)
Change in Glycemic Risk Index (GRI)
Time frame: 90 days
GRI (Hyperglycemia Component/Hypoglycemia Component)
Change in average glucose values at 90 days post discharge.
Time frame: 90 days
Change in Average glucose values (mg/dL)
9 secondary outcomes
Change in 30-day readmission rates
Time frame: 30 days
Change in 60-day readmission rates
Time frame: 60 days
Change in 90-day readmission rates
Time frame: 90 days
Change in Emergency Department (ED) visits at 30-days
Time frame: 30 days
Change in ED visits at 60 days
Time frame: 60 days
Change in ED visits at 90 days
Time frame: 90 days
Change in Mortality rates at 30 days
Time frame: 30 days
Change in mortality rates at 60 days
Time frame: 60 days
Change in mortality rates at 90 days
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No. IPD information is not necessary to share our study findings to the sponsor or peer-review organizations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ilias Spanakis, MD principal investigator
Baltimore VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitor in people with Diabetes (DM), run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William H Scott, MA (410 605 7000 ext. 53558, William.Scott5@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycemic control (time frame: 90 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.