Type 1 DiabetesNCT06752928
A Study Comparing Dexcom Continuous Glucose Monitoring to Point of Care Glucose Testing for the Management of Hospital and Post-Discharge Subjects With Type 1 Diabetes
A study testing Dexcom G7 rtCGM and Capillary Blood glucose Testing (POC) in people with Type 1 Diabetes, run by Emory University at 1 site in United States.
Trial summary
This study aims to compare inpatient glycemic control by measuring the percentage of time in the range of 70-180 mg/dl and the frequency of hypoglycemia between Dexcom G7 Continuous Glucose Monitoring (CGM) and Point of Care (POC) Blood Glucose Testing in poorly controlled subjects with Type 1 Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Dexcom G7 rtCGM and Capillary Blood glucose Testing (POC)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2025to Oct 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Known history of T1D treated with insulin therapy (human regular or rapid-acting analogs or ultra-rapid analogs [lispro, aspart, glulisine, fast-acting insulin aspart, insulin lispro]), intermediate-acting (NPH and premixed formulations) or long-acting basal (glargine, detemir, degludec) formulations.
- Admission diagnosis of T1D with poorly controlled diabetes (blood glucose > 180 mg/dl, HbA1c > 7%), including diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar state (HHS).
- Expected length of hospital stay > three days at the time of randomization
Who cannot join
- Patients admitted to the ICU
- Subjects using CGM technology before admission
- Subjects with type 2 diabetes
- Treatment with systemic immunosuppressive agents
- Cystic fibrosis
- Prisoners
Show all 11Show fewer
- Patients expected to require MRI procedures during hospitalization.
- Female subjects who are pregnant or breastfeeding at enrollment into the study.
- Subjects not willing to wear a CGM device
- Subjects with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension) and end-stage kidney disease (eGFR< 30 ml/min), or terminal illness.
- Subjects with a history of cognitive impairment, dementia, or mental condition rendering the subject unable to understand the nature and consequences of the study
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, 1 recruiting
- Recruiting
Grady Memorial Hospital
Atlanta, Georgia, 30303
Guillermo Umpierrez, MD, 404-778-1665, geumpie@emory.edu
About this study
Official title: A Randomized Controlled Trial Comparing Dexcom Continuous Glucose Monitoring to Point of Care Glucose Testing for the Management of Hospital and Post-Discharge Subjects With Type 1 Diabetes
This study aims to compare inpatient glycemic control by measuring the percentage of time in the range of 70-180 mg/dl and the frequency of hypoglycemia between Dexcom G7 Continuous Glucose Monitoring (CGM) and Point of Care (POC) Blood Glucose Testing in poorly controlled subjects with Type 1 Diabetes Mellitus.
The main question it aims to answer is:
-Whether there is a difference between POC testing (standard of care) and Real-time CGM in glycemic control and hypoglycemic events during hospitalization:
Read the detailed description
The CDC reports that 1.6 million U.S. adults (5.7%) have type 1 diabetes (T1D), with hospitalization rates three times higher than the general population, primarily due to diabetes-related complications such as ketoacidosis and cardiovascular disease. A study at Emory University found that hospitalized T1D patients are younger, experience longer stays and more admissions, and face worse glycemic control and higher rates of hypoglycemia compared to type 2 diabetes (T2D) patients.
Point-of-care (POC) capillary glucose testing is the standard for monitoring hospitalized diabetes patients, but continuous glucose monitoring (CGM) offers more detailed glycemic profiles. Research, including trials using Dexcom CGM systems, has demonstrated CGM's superior ability to detect hypo- and hyperglycemia, reduce hypoglycemic events, and improve insulin therapy adjustments in T2D patients. However, no randomized controlled studies have evaluated the best glucose monitoring system for hospitalized T1D patients.
The proposed study aims to compare POC testing with Dexcom G7 CGM for guiding insulin therapy in hospitalized T1D patients. Researchers hypothesize that CGM will better prevent hypoglycemia and improve glycemic management during hospital stays, addressing a critical gap in evidence regarding glucose control's impact on T1D hospital outcomes.
- Conditions
- Type 1 Diabetes
- Being tested
- Dexcom G7 rtCGM, Capillary Blood glucose Testing (POC)
- Keywords
- Continuous Glucose Monitoring, Type 1 Diabetes Mellitus, Point of Care
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G7 rtCGMDevice
The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 CGM System or G7) is a glucose monitoring system that continuously measures glucose in the interstitial fluid. It aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments
Capillary Blood glucose Testing (POC)Diagnostic test
Also called POCT (point of care therapy)
POC glucose meters measure whole blood and convert the results to plasma glucose concentrations, which is the standardized form used in clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Severe hyperglycemia will be managed by primary care professionals (Hospitalist Service) with intravenous or subcutaneous insulin therapy. Subjects will be invited to participate in the study after the resolution of severe hyperglycemia (BG < 400 mg/dl). Glucose monitoring by POC testing will be performed before meals and at bedtime. Results will be uploaded to the electronic medical record (EMR) system. The research team, together with the Primary care (PCP) team, will adjust daily insulin orders based on POC readings (standard of care). In addition, subjects will wear a 'blinded' CGM (no results will be visualized by patients, nursing staff, medicine, or research teams) during hospitalization for up to 10 days. Receives: Diagnostic Test: Capillary Blood glucose Testing (POC) |
| Dexcom CGM | Experimental | Severe hyperglycemia will be managed by primary care professionals (Hospitalist Service) intravenously with subcutaneous insulin therapy. Subjects will be invited to participate in the study after the resolution of severe hyperglycemia (BG < 400 mg/dl). Subjects will wear a real-time Dexcom G7 CGM for up to 10 days. Insulin therapy will be titrated based on daily CGM reports, including mean glucose, glycemic excursions, hypoglycemia, and severe hyperglycemia > 180 and >250 mg/dl values. Participants will wear a Dexcom rtCGM for up to 10 days during hospitalization. Receives: Device: Dexcom G7 rtCGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
The total difference in blood sugar levels between the POC testing (standard of care) group and the rtCGM group throughout the hospitalization
Measured: Through study completion (Day 10 or the length of admission)
Clinically significant hypoglycemia <54 mg/dl
The difference between blood sugar levels in POC testing (standard of care) group and rtCGM group during hospitalization
Measured: Through study completion (Day 10 or the length of admission)
Secondary outcomes (10)
Time above range
% time above Target Above range (TAR). Differences between the both groups will be calculated. (TAR, >250 mg/dl)
Measured: Through study completion (Day 10 or the length of admission)
Time below range
% time in Below Target range (TBR). Differences between the both groups will be calculated.
Differences between the both groups will be calculated. (TBR, < 70 and 54 mg/dl)
Measured: Through study completion (Day 10 or the length of admission)
Glycemic Variability [% Coefficient of Variation (%CV)
% coefficient of variation will be measured during the intervention phase, compared to control, as measured by CGM.
Measured: Through study completion (Day 10 or the length of admission)
Hypoglycemic events
Number of hypoglycemia events < 70 and 54 mg/dl
Measured: Through study completion (Day 10 or the length of admission)
Hyperglycemic events
Number of hypoglycemia events >250 mg/dl
Measured: Through study completion (Day 10 or the length of admission)
Nocturnal hypoglycemia
Number of hypoglycemic events (<70 and <54 mg/dl) between 22:00 and 06:00
Measured: Through study completion (Day 10 or the length of admission)
Prolonged hypoglycemia
Number of events of Prolonged hypoglycemia < 70 mg/dl for more than 2 hours by CGM
Measured: Through study completion (Day 10 or the length of admission)
Hospital Complications
Hospital complications include a composite of acute kidney injury (doubling of serum creatinine >0.5 mg/dl from baseline), cardiovascular events, infections, and death
Measured: Through study completion (Day 10 or the length of admission)
Recurrent hypoglycemia
Number of recurrent hypoglycemic episodes (< 70 mg/dl)
Measured: Through study completion (Day 10 or the length of admission)
Recurrent hyperglycemia
Number of recurrent hyperglycemic episodes (>250 mg/dl)
Measured: Through study completion (Day 10 or the length of admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start12 May 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Model description
- Research design Adult subjects with T1D admitted to non-ICU medicine and surgery units and receiving insulin therapy will be randomized to either standard POC testing or Dexcom G7 CGM to guide insulin dose adjustments, with the POC group wearing a blinded CGM and the CGM group having insulin adjustments based on daily glucose profiles.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Principal investigator, Guillermo Umpierrez, Emory University
- Investigators
- Guillermo Umpierrez, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752928
- Sponsor's protocol ID
- STUDY00008724
- Status last verified
- Jul 2025
- First submitted
- 17 Dec 2024
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Dexcom Continuous Glucose Monitoring to Point of Care Glucose Testing for the Management of Hospital and Post-Discharge Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06752928
- Acronym / sponsor ID
- STUDY00008724
- Conditions
- Type 1 Diabetes
- Keywords
- Continuous Glucose Monitoring, Type 1 Diabetes Mellitus, Point of Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 12 May 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 31 Dec 2024 (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.
This study aims to compare inpatient glycemic control by measuring the percentage of time in the range of 70-180 mg/dl and the frequency of hypoglycemia between Dexcom G7 Continuous Glucose Monitoring (CGM) and Point of Care (POC) Blood Glucose Testing in poorly controlled subjects with Type 1 Diabetes Mellitus.
The main question it aims to answer is:
-Whether there is a difference between POC testing (standard of care) and Real-time CGM in glycemic control and hypoglycemic events during hospitalization:
Detailed description
The CDC reports that 1.6 million U.S. adults (5.7%) have type 1 diabetes (T1D), with hospitalization rates three times higher than the general population, primarily due to diabetes-related complications such as ketoacidosis and cardiovascular disease. A study at Emory University found that hospitalized T1D patients are younger, experience longer stays and more admissions, and face worse glycemic control and higher rates of hypoglycemia compared to type 2 diabetes (T2D) patients.
Point-of-care (POC) capillary glucose testing is the standard for monitoring hospitalized diabetes patients, but continuous glucose monitoring (CGM) offers more detailed glycemic profiles. Research, including trials using Dexcom CGM systems, has demonstrated CGM's superior ability to detect hypo- and hyperglycemia, reduce hypoglycemic events, and improve insulin therapy adjustments in T2D patients. However, no randomized controlled studies have evaluated the best glucose monitoring system for hospitalized T1D patients.
The proposed study aims to compare POC testing with Dexcom G7 CGM for guiding insulin therapy in hospitalized T1D patients. Researchers hypothesize that CGM will better prevent hypoglycemia and improve glycemic management during hospital stays, addressing a critical gap in evidence regarding glucose control's impact on T1D hospital outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Research design Adult subjects with T1D admitted to non-ICU medicine and surgery units and receiving insulin therapy will be randomized to either standard POC testing or Dexcom G7 CGM to guide insulin dose adjustments, with the POC group wearing a blinded CGM and the CGM group having insulin adjustments based on daily glucose profiles.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Diagnostic Test: Capillary Blood glucose Testing (POC)Severe hyperglycemia will be managed by primary care professionals (Hospitalist Service) with intravenous or subcutaneous insulin therapy. Subjects will be invited to participate in the study after the resolution of severe hyperglycemia (BG < 400 mg/dl). Glucose monitoring by POC testing will be performed before meals and at bedtime. Results will be uploaded to the electronic medical record (EMR) system. The research team, together with the Primary care (PCP) team, will adjust daily insulin orders based on POC readings (standard of care). In addition, subjects will wear a 'blinded' CGM (no results will be visualized by patients, nursing staff, medicine, or research teams) during hospitalization for up to 10 days. |
| Dexcom CGM | Experimental | Device: Dexcom G7 rtCGMSevere hyperglycemia will be managed by primary care professionals (Hospitalist Service) intravenously with subcutaneous insulin therapy. Subjects will be invited to participate in the study after the resolution of severe hyperglycemia (BG < 400 mg/dl). Subjects will wear a real-time Dexcom G7 CGM for up to 10 days. Insulin therapy will be titrated based on daily CGM reports, including mean glucose, glycemic excursions, hypoglycemia, and severe hyperglycemia > 180 and >250 mg/dl values. Participants will wear a Dexcom rtCGM for up to 10 days during hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Known history of T1D treated with insulin therapy (human regular or rapid-acting analogs or ultra-rapid analogs [lispro, aspart, glulisine, fast-acting insulin aspart, insulin lispro]), intermediate-acting (NPH and premixed formulations) or long-acting basal (glargine, detemir, degludec) formulations.
- Admission diagnosis of T1D with poorly controlled diabetes (blood glucose > 180 mg/dl, HbA1c > 7%), including diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar state (HHS).
- Expected length of hospital stay > three days at the time of randomization
Key exclusion criteria (11 listed)
- Patients admitted to the ICU
- Subjects using CGM technology before admission
- Subjects with type 2 diabetes
- Treatment with systemic immunosuppressive agents
- Cystic fibrosis
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 |
|---|---|---|
| Dexcom G7 rtCGMThe Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 CGM System or G7) is a glucose monitoring system that continuously measures glucose in the interstitial fluid. It aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments | Device | Dexcom CGM |
| Capillary Blood glucose Testing (POC)Also: POCT (point of care therapy)POC glucose meters measure whole blood and convert the results to plasma glucose concentrations, which is the standardized form used in clinical practice. | Diagnostic test | Standard of Care |
Primary outcome
Glycemic control
Time frame: Through study completion (Day 10 or the length of admission)
The total difference in blood sugar levels between the POC testing (standard of care) group and the rtCGM group throughout the hospitalization
Clinically significant hypoglycemia <54 mg/dl
Time frame: Through study completion (Day 10 or the length of admission)
The difference between blood sugar levels in POC testing (standard of care) group and rtCGM group during hospitalization
10 secondary outcomes
Time above range
Time frame: Through study completion (Day 10 or the length of admission)
Time below range
Time frame: Through study completion (Day 10 or the length of admission)
Glycemic Variability [% Coefficient of Variation (%CV)
Time frame: Through study completion (Day 10 or the length of admission)
Hypoglycemic events
Time frame: Through study completion (Day 10 or the length of admission)
Hyperglycemic events
Time frame: Through study completion (Day 10 or the length of admission)
Nocturnal hypoglycemia
Time frame: Through study completion (Day 10 or the length of admission)
Prolonged hypoglycemia
Time frame: Through study completion (Day 10 or the length of admission)
Hospital Complications
Time frame: Through study completion (Day 10 or the length of admission)
Recurrent hypoglycemia
Time frame: Through study completion (Day 10 or the length of admission)
Recurrent hyperglycemia
Time frame: Through study completion (Day 10 or the length of admission)
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 8 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Guillermo Umpierrez, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom G7 rtCGM and Capillary Blood glucose Testing (POC) in people with Type 1 Diabetes, run by Emory University 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 11 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: looking for participants now, as of the sponsor's last update on 8 Oct 2025. 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 Guillermo Umpierrez, MD (404-778-1665, geumpie@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: Through study completion (Day 10 or the length of admission)). The study lists 2 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 8 Oct 2025.