Diabetes Mellitus, Type 2NCT03508934
Continuous Glucose Monitoring Devices in Hospitalized Veterans With Diabetes
A study testing GTS (Continuous Glucose Monitoring) and POC (Point of Care) in people with Diabetes Mellitus, Type 2 and Hypoglycemia, run by VA Office of Research and Development at 1 site in United States.
Trial summary
More than 25% of the patients admitted in the general wards have a history of Diabetes Mellitus (DM). Up to 30% of the hospitalized diabetics develop hypoglycemia (low glucose values); a condition that is associated with seizures, cardiac arrhythmias, and even death. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypoglycemia
- What is being tested?
- GTS (Continuous Glucose Monitoring) and POC (Point of Care)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 30 Apr 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans with history of DM2 managed with insulin (either basal bolus, basal only or basal with per os DM medications), admitted to the Baltimore VA Medical Center, who have at
- least 1 risk factor of hypoglycemia
Who cannot join
- Veterans with history of type 1 DM.
- Veterans with history of DM2 managed with diet or any combination of oral antidiabetic drugs only.
- Veterans hospitalized with significant hyperglycemia or diabetic ketoacidosis
- Pregnant Veterans
- Veterans receiving glucocorticosteroids in doses (equivalent) to 20 mg of hydrocortisone/day
- Veterans that are expected to require a hospital stay <3 days will also be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
About this study
Official title: Continuous Glucose Monitoring in Insulin Treated Hospitalized Veterans With DM2 at Higher Risk for Hypoglycemia
More than 25% of the patients admitted in the general wards have a history of Diabetes Mellitus (DM). Up to 30% of the hospitalized diabetics develop hypoglycemia (low glucose values); a condition that is associated with seizures, cardiac arrhythmias, and even death. In Veterans, the prevalence is disproportionally higher. It is estimated that 40-50% of hospitalized Veterans are diabetics. In this clinical trial the investigators describe the development of a novel system, the Glucose Telemetry System (GTS), with which glucose values can be wirelessly transmitted from the patient's bedside to a monitor device at the nursing station. The goal of this work is to develop a more effective glucose surveillance system at the general wards, which can decrease hypoglycemia in the hospital and improve clinical outcomes.
Read the detailed description
More than 25% of patients admitted to general wards/non Intensive Care Unit (non-ICU) setting have a history of Diabetes Mellitus (DM); and as for 2012, $125 billion dollars were costs associated with hospitalization of diabetics in the United States (US). Up to 30% of the hospitalized diabetics develop hypoglycemia, a condition that is associated with higher hospital charges, prolonged length of stay, and increased morbidity and mortality.
Reducing hypoglycemic events in the inpatient setting has led hospitals to develop hypoglycemia prevention policies; policies which are however limited by the infrequent Point of Care (POC) capillary blood glucose testing in the general wards. Continuous Glucose Monitoring (CGM) devices represent additional ways to monitor blood glucose levels. Only a limited number of studies have examined the use of CGM devices in the non-ICU setting. In all these studies, CGM use was found to be superior compared to POC in hypoglycemia detection. However, as the results of CGM were blinded (alarms were turned off) for both the investigators and the participants, interventions to prevent hypoglycemia were not performed. Additionally, one major limitation of CGM technology is that CGM receiver/monitor needs to be located in the patient's room, due to Bluetooth Technology signal-strength restrictions, necessitating nurses to enter frequently the patient's room in order to check CGM glucose values. In the current application, the investigators are going to evaluate whether an innovative system that the investigators call "Glucose Telemetry System" (GTS) can decrease hypoglycemia and improve clinical outcomes in hospitalized Veterans with DM2.
Discovering novel ways to monitor glucose values in the hospital setting could have a significant impact in preventing hypoglycemia in the inpatient setting- a condition that is associated with adverse clinical outcomes. The investigators believe that this proposal is highly innovative. The trial may lead to future wider use of CGM in hospitalized patients with DM who are at a higher risk for hypoglycemia, similar to the way that the investigators use cardiac telemetry for patients who are at an increased risk for developing arrhythmias.
- Conditions
- Diabetes Mellitus, Type 2, Hypoglycemia
- Being tested
- GTS (Continuous Glucose Monitoring), POC (Point of Care)
- Keywords
- Diabetes Mellitus, Type 2, hypoglycemia, Continuous Glucose Monitoring, hospital, inpatient
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTS (Continuous Glucose Monitoring)Device
Hospitalized patients with DM2 will be monitored with Glucose Telemetry System (GTS)
POC (Point of Care)Other
Hospitalized patients with DM2 will be monitored with POC (Point of Care) blood glucose levels.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (Continuous Glucose Monitroring and POC) | Active comparator | Hospitalized patients with DM2 will be monitored with Glucose Telemetry System (GTS) and Point of Care (POC) finger-stick blood glucose levels with application of hypoglycemia prevention protocol (activated based the GTS lower glucose alarms) Receives: Device: GTS (Continuous Glucose Monitoring); Other: POC (Point of Care) |
| Control group (Point of Care-POC) | Placebo comparator | Hospitalized patients with DM2 will be monitored with POC blood glucose levels and application of hypoglycemia prevention protocol (activated based the POC values) Receives: Other: POC (Point of Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in hypoglycemia during the hospitalization
GTS and the application of the hypoglycemia prevention protocol will lead to a decrease in hypoglycemia in the hospital
Measured: Through study completion-hospitalization (average length of stay at the hospital of 4-6 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start1 Jul 2018
- Primary completion11 Jul 2025
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Glucose Telemetry System (Continuous Glucose Monitoring Devices) Active Comparator: Intervention group (Continuous Glucose Monitroring and POC) Hospitalized patients with DM2 will be monitored with Glucose Telemetry System (GTS) and Point of Care (POC) finger-stick blood glucose levels with application of hypoglycemia prevention protocol (activated based the GTS lower glucose alarms) Placebo Comparator: Control group (Point of Care-POC) Hospitalized patients with DM2 will be monitored with POC blood glucose levels and application of hypoglycemia prevention protocol (activated based the POC values)
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ilias Spanakis, MD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508934
- Sponsor's protocol ID
- ENDA-022-17F
- Other IDs
- CX001825-01
- Status last verified
- Jan 2026
- First submitted
- 10 Apr 2018
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The investigators will willingly share de-identified data to qualified investigators who wish to perform any additional analyses, including validation of results. Researchers need also to have completed Human Subjects and HIPPA training. Data will be provided after the end of the study. Study findings may also be presented at scientific meetings (such as American Diabetes Association and Diabetes Technology Society meetings). Study findings may also be presented at Medical and Endocrine Grand Rounds nationally. Final data sets (i.e demographic data, medication usage data, glucometric values) will be maintained locally (VABMC server) until enterprise-level resources become available for long term storage and access.
Publications
Satyarengga M, Siddiqui T, Spanakis EK. Designing the Glucose Telemetry for Hospital Management: From Bedside to the Nursing Station. Curr Diab Rep. 2018 Aug 29;18(10):87. doi: 10.1007/s11892-018-1067-4.
PubMed 30159754Wang M, Singh LG, Spanakis EK. Advancing the Use of CGM Devices in a Non-ICU Setting. J Diabetes Sci Technol. 2019 Jul;13(4):674-681. doi: 10.1177/1932296818821094. Epub 2019 Jan 13.
PubMed 30636449Ngaage LM, Osadebey EN, Tullie STE, Elegbede A, Rada EM, Spanakis EK, Goldberg N, Slezak S, Rasko YM. An Update on Measures of Preoperative Glycemic Control. Plast Reconstr Surg Glob Open. 2019 May 16;7(5):e2240. doi: 10.1097/GOX.0000000000002240. eCollection 2019 May.
PubMed 31333965Nguyen M, Han J, Spanakis EK, Kovatchev BP, Klonoff DC. A Review of Continuous Glucose Monitoring-Based Composite Metrics for Glycemic Control. Diabetes Technol Ther. 2020 Aug;22(8):613-622. doi: 10.1089/dia.2019.0434. Epub 2020 Mar 4.
PubMed 32069094Chen E, King F, Kohn MA, Spanakis EK, Breton M, Klonoff DC. A Review of Predictive Low Glucose Suspend and Its Effectiveness in Preventing Nocturnal Hypoglycemia. Diabetes Technol Ther. 2019 Oct;21(10):602-609. doi: 10.1089/dia.2019.0119.
PubMed 31335193Spanakis EK, Singh LG, Siddiqui T, Sorkin JD, Notas G, Magee MF, Fink JC, Zhan M, Umpierrez GE. Association of glucose variability at the last day of hospitalization with 30-day readmission in adults with diabetes. BMJ Open Diabetes Res Care. 2020 May;8(1):e000990. doi: 10.1136/bmjdrc-2019-000990.
PubMed 32398351Spanakis EK. Diabetes and Technology in the Covid-19 Pandemic Crisis. J Diabetes Sci Technol. 2021 Mar;15(2):377-378. doi: 10.1177/1932296820929385. Epub 2020 May 27. No abstract available.
PubMed 32460544Galindo RJ, Aleppo G, Klonoff DC, Spanakis EK, Agarwal S, Vellanki P, Olson DE, Umpierrez GE, Davis GM, Pasquel FJ. Implementation of Continuous Glucose Monitoring in the Hospital: Emergent Considerations for Remote Glucose Monitoring During the COVID-19 Pandemic. J Diabetes Sci Technol. 2020 Jul;14(4):822-832. doi: 10.1177/1932296820932903. Epub 2020 Jun 14.
PubMed 32536205Umpierrez G, Rushakoff R, Seley JJ, Zhang JY, Shang T, Han J, Spanakis EK, Alexanian S, Drincic A, Kulasa K, Mendez CE, Tanton D, Wallia A, Zilbermint M, Klonoff DC. Hospital Diabetes Meeting 2020. J Diabetes Sci Technol. 2020 Sep;14(5):928-944. doi: 10.1177/1932296820939626. Epub 2020 Aug 12.
PubMed 32783456Galindo RJ, Umpierrez GE, Rushakoff RJ, Basu A, Lohnes S, Nichols JH, Spanakis EK, Espinoza J, Palermo NE, Awadjie DG, Bak L, Buckingham B, Cook CB, Freckmann G, Heinemann L, Hovorka R, Mathioudakis N, Newman T, O'Neal DN, Rickert M, Sacks DB, Seley JJ, Wallia A, Shang T, Zhang JY, Han J, Klonoff DC. Continuous Glucose Monitors and Automated Insulin Dosing Systems in the Hospital Consensus Guideline. J Diabetes Sci Technol. 2020 Nov;14(6):1035-1064. doi: 10.1177/1932296820954163. Epub 2020 Sep 28.
PubMed 32985262Singh LG, Satyarengga M, Marcano I, Scott WH, Pinault LF, Feng Z, Sorkin JD, Umpierrez GE, Spanakis EK. Reducing Inpatient Hypoglycemia in the General Wards Using Real-time Continuous Glucose Monitoring: The Glucose Telemetry System, a Randomized Clinical Trial. Diabetes Care. 2020 Nov;43(11):2736-2743. doi: 10.2337/dc20-0840. Epub 2020 Aug 5.
PubMed 32759361Migdal AL, Spanakis EK, Galindo RJ, Davis G, Singh LG, Satyarengga M, Scott WH, Fayfman M, Pasquel FJ, Albury B, Urrutia M, Zamudio Coronado KW, Cardona S, Peng L, Umpierrez GE. Accuracy and Precision of Continuous Glucose Monitoring in Hospitalized Patients Undergoing Radiology Procedures. J Diabetes Sci Technol. 2020 Nov;14(6):1135-1136. doi: 10.1177/1932296820930038. Epub 2020 Jun 1. No abstract available.
PubMed 32476459Zhang JY, Shang T, Ahn D, Chen K, Cote G, Espinoza J, Mendez CE, Spanakis EK, Thompson B, Wallia A, Wisk LE, Kerr D, Klonoff DC. How to Best Protect People With Diabetes From the Impact of SARS-CoV-2: Report of the International COVID-19 and Diabetes Summit. J Diabetes Sci Technol. 2021 Mar;15(2):478-514. doi: 10.1177/1932296820978399. Epub 2021 Jan 21.
PubMed 33476193Davis GM, Spanakis EK, Migdal AL, Singh LG, Albury B, Urrutia MA, Zamudio-Coronado KW, Scott WH, Doerfler R, Lizama S, Satyarengga M, Munir K, Galindo RJ, Vellanki P, Cardona S, Pasquel FJ, Peng L, Umpierrez GE. Accuracy of Dexcom G6 Continuous Glucose Monitoring in Non-Critically Ill Hospitalized Patients With Diabetes. Diabetes Care. 2021 Jul;44(7):1641-1646. doi: 10.2337/dc20-2856. Epub 2021 Jun 7.
PubMed 34099515Ash GI, Griggs S, Nally LM, Stults-Kolehmainen M, Jeon S, Brandt C, Gulanski BI, Spanakis EK, Baker JS, Whittemore R, Weinzimer SA, Fucito LM. Evaluation of Web-Based and In-Person Methods to Recruit Adults With Type 1 Diabetes for a Mobile Exercise Intervention: Prospective Observational Study. JMIR Diabetes. 2021 Jul 8;6(3):e28309. doi: 10.2196/28309.
PubMed 34047700
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring in Insulin Treated Hospitalized Veterans With DM2 at Higher Risk for Hypoglycemia
- ClinicalTrials.gov ID
- NCT03508934
- Acronym / sponsor ID
- ENDA-022-17F
- Conditions
- Diabetes Mellitus, Type 2, Hypoglycemia
- Keywords
- Diabetes Mellitus, Type 2, hypoglycemia, Continuous Glucose Monitoring, hospital, inpatient
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 218 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 11 Jul 2025 (actual)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 26 Apr 2018 (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.
More than 25% of the patients admitted in the general wards have a history of Diabetes Mellitus (DM). Up to 30% of the hospitalized diabetics develop hypoglycemia (low glucose values); a condition that is associated with seizures, cardiac arrhythmias, and even death. In Veterans, the prevalence is disproportionally higher. It is estimated that 40-50% of hospitalized Veterans are diabetics. In this clinical trial the investigators describe the development of a novel system, the Glucose Telemetry System (GTS), with which glucose values can be wirelessly transmitted from the patient's bedside to a monitor device at the nursing station. The goal of this work is to develop a more effective glucose surveillance system at the general wards, which can decrease hypoglycemia in the hospital and improve clinical outcomes.
Detailed description
More than 25% of patients admitted to general wards/non Intensive Care Unit (non-ICU) setting have a history of Diabetes Mellitus (DM); and as for 2012, $125 billion dollars were costs associated with hospitalization of diabetics in the United States (US). Up to 30% of the hospitalized diabetics develop hypoglycemia, a condition that is associated with higher hospital charges, prolonged length of stay, and increased morbidity and mortality.
Reducing hypoglycemic events in the inpatient setting has led hospitals to develop hypoglycemia prevention policies; policies which are however limited by the infrequent Point of Care (POC) capillary blood glucose testing in the general wards. Continuous Glucose Monitoring (CGM) devices represent additional ways to monitor blood glucose levels. Only a limited number of studies have examined the use of CGM devices in the non-ICU setting. In all these studies, CGM use was found to be superior compared to POC in hypoglycemia detection. However, as the results of CGM were blinded (alarms were turned off) for both the investigators and the participants, interventions to prevent hypoglycemia were not performed. Additionally, one major limitation of CGM technology is that CGM receiver/monitor needs to be located in the patient's room, due to Bluetooth Technology signal-strength restrictions, necessitating nurses to enter frequently the patient's room in order to check CGM glucose values. In the current application, the investigators are going to evaluate whether an innovative system that the investigators call "Glucose Telemetry System" (GTS) can decrease hypoglycemia and improve clinical outcomes in hospitalized Veterans with DM2.
Discovering novel ways to monitor glucose values in the hospital setting could have a significant impact in preventing hypoglycemia in the inpatient setting- a condition that is associated with adverse clinical outcomes. The investigators believe that this proposal is highly innovative. The trial may lead to future wider use of CGM in hospitalized patients with DM who are at a higher risk for hypoglycemia, similar to the way that the investigators use cardiac telemetry for patients who are at an increased risk for developing arrhythmias.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Glucose Telemetry System (Continuous Glucose Monitoring Devices) Active Comparator: Intervention group (Continuous Glucose Monitroring and POC) Hospitalized patients with DM2 will be monitored with Glucose Telemetry System (GTS) and Point of Care (POC) finger-stick blood glucose levels with application of hypoglycemia prevention protocol (activated based the GTS lower glucose alarms) Placebo Comparator: Control group (Point of Care-POC) Hospitalized patients with DM2 will be monitored with POC blood glucose levels and application of hypoglycemia prevention protocol (activated based the POC values)
| Arm | Type | Receives |
|---|---|---|
| Intervention group (Continuous Glucose Monitroring and POC) | Active comparator | Device: GTS (Continuous Glucose Monitoring), Other: POC (Point of Care)Hospitalized patients with DM2 will be monitored with Glucose Telemetry System (GTS) and Point of Care (POC) finger-stick blood glucose levels with application of hypoglycemia prevention protocol (activated based the GTS lower glucose alarms) |
| Control group (Point of Care-POC) | Placebo comparator | Other: POC (Point of Care)Hospitalized patients with DM2 will be monitored with POC blood glucose levels and application of hypoglycemia prevention protocol (activated based the POC values) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Veterans with history of DM2 managed with insulin (either basal bolus, basal only or basal with per os DM medications), admitted to the Baltimore VA Medical Center, who have at
Key exclusion criteria (6 listed)
- Veterans with history of type 1 DM.
- Veterans with history of DM2 managed with diet or any combination of oral antidiabetic drugs only.
- Veterans hospitalized with significant hyperglycemia or diabetic ketoacidosis
- Pregnant Veterans
- Veterans receiving glucocorticosteroids in doses (equivalent) to 20 mg of hydrocortisone/day
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 |
|---|---|---|
| GTS (Continuous Glucose Monitoring)Hospitalized patients with DM2 will be monitored with Glucose Telemetry System (GTS) | Device | Intervention group (Continuous Glucose Monitroring and POC) |
| POC (Point of Care)Hospitalized patients with DM2 will be monitored with POC (Point of Care) blood glucose levels. | Other | Control group (Point of Care-POC), Intervention group (Continuous Glucose Monitroring and POC) |
Primary outcome
Decrease in hypoglycemia during the hospitalization
Time frame: Through study completion-hospitalization (average length of stay at the hospital of 4-6 days)
GTS and the application of the hypoglycemia prevention protocol will lead to a decrease in hypoglycemia in the hospital
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 7 Jan 2026.
- Background: PubMed 30159754Satyarengga M, Siddiqui T, Spanakis EK. Designing the Glucose Telemetry for Hospital Management: From Bedside to the Nursing Station. Curr Diab Rep. 2018 Aug 29;18(10):87. doi: 10.1007/s11892-018-1067-4.
- Background: PubMed 30636449Wang M, Singh LG, Spanakis EK. Advancing the Use of CGM Devices in a Non-ICU Setting. J Diabetes Sci Technol. 2019 Jul;13(4):674-681. doi: 10.1177/1932296818821094. Epub 2019 Jan 13.
- Background: PubMed 31333965Ngaage LM, Osadebey EN, Tullie STE, Elegbede A, Rada EM, Spanakis EK, Goldberg N, Slezak S, Rasko YM. An Update on Measures of Preoperative Glycemic Control. Plast Reconstr Surg Glob Open. 2019 May 16;7(5):e2240. doi: 10.1097/GOX.0000000000002240. eCollection 2019 May.
- Background: PubMed 32069094Nguyen M, Han J, Spanakis EK, Kovatchev BP, Klonoff DC. A Review of Continuous Glucose Monitoring-Based Composite Metrics for Glycemic Control. Diabetes Technol Ther. 2020 Aug;22(8):613-622. doi: 10.1089/dia.2019.0434. Epub 2020 Mar 4.
- Background: PubMed 31335193Chen E, King F, Kohn MA, Spanakis EK, Breton M, Klonoff DC. A Review of Predictive Low Glucose Suspend and Its Effectiveness in Preventing Nocturnal Hypoglycemia. Diabetes Technol Ther. 2019 Oct;21(10):602-609. doi: 10.1089/dia.2019.0119.
- Background: PubMed 32398351Spanakis EK, Singh LG, Siddiqui T, Sorkin JD, Notas G, Magee MF, Fink JC, Zhan M, Umpierrez GE. Association of glucose variability at the last day of hospitalization with 30-day readmission in adults with diabetes. BMJ Open Diabetes Res Care. 2020 May;8(1):e000990. doi: 10.1136/bmjdrc-2019-000990.
- Background: PubMed 32460544Spanakis EK. Diabetes and Technology in the Covid-19 Pandemic Crisis. J Diabetes Sci Technol. 2021 Mar;15(2):377-378. doi: 10.1177/1932296820929385. Epub 2020 May 27. No abstract available.
- Background: PubMed 32536205Galindo RJ, Aleppo G, Klonoff DC, Spanakis EK, Agarwal S, Vellanki P, Olson DE, Umpierrez GE, Davis GM, Pasquel FJ. Implementation of Continuous Glucose Monitoring in the Hospital: Emergent Considerations for Remote Glucose Monitoring During the COVID-19 Pandemic. J Diabetes Sci Technol. 2020 Jul;14(4):822-832. doi: 10.1177/1932296820932903. Epub 2020 Jun 14.
- Background: PubMed 32783456Umpierrez G, Rushakoff R, Seley JJ, Zhang JY, Shang T, Han J, Spanakis EK, Alexanian S, Drincic A, Kulasa K, Mendez CE, Tanton D, Wallia A, Zilbermint M, Klonoff DC. Hospital Diabetes Meeting 2020. J Diabetes Sci Technol. 2020 Sep;14(5):928-944. doi: 10.1177/1932296820939626. Epub 2020 Aug 12.
- Background: PubMed 32985262Galindo RJ, Umpierrez GE, Rushakoff RJ, Basu A, Lohnes S, Nichols JH, Spanakis EK, Espinoza J, Palermo NE, Awadjie DG, Bak L, Buckingham B, Cook CB, Freckmann G, Heinemann L, Hovorka R, Mathioudakis N, Newman T, O'Neal DN, Rickert M, Sacks DB, Seley JJ, Wallia A, Shang T, Zhang JY, Han J, Klonoff DC. Continuous Glucose Monitors and Automated Insulin Dosing Systems in the Hospital Consensus Guideline. J Diabetes Sci Technol. 2020 Nov;14(6):1035-1064. doi: 10.1177/1932296820954163. Epub 2020 Sep 28.
- Background: PubMed 32759361Singh LG, Satyarengga M, Marcano I, Scott WH, Pinault LF, Feng Z, Sorkin JD, Umpierrez GE, Spanakis EK. Reducing Inpatient Hypoglycemia in the General Wards Using Real-time Continuous Glucose Monitoring: The Glucose Telemetry System, a Randomized Clinical Trial. Diabetes Care. 2020 Nov;43(11):2736-2743. doi: 10.2337/dc20-0840. Epub 2020 Aug 5.
- Background: PubMed 32476459Migdal AL, Spanakis EK, Galindo RJ, Davis G, Singh LG, Satyarengga M, Scott WH, Fayfman M, Pasquel FJ, Albury B, Urrutia M, Zamudio Coronado KW, Cardona S, Peng L, Umpierrez GE. Accuracy and Precision of Continuous Glucose Monitoring in Hospitalized Patients Undergoing Radiology Procedures. J Diabetes Sci Technol. 2020 Nov;14(6):1135-1136. doi: 10.1177/1932296820930038. Epub 2020 Jun 1. No abstract available.
- Individual participant dataSharing planned: Yes. The investigators will willingly share de-identified data to qualified investigators who wish to perform any additional analyses, including validation of results. Researchers need also to have completed Human Subjects and HIPPA training. Data will be provided after the end of the study. Study findings may also be presented at scientific meetings (such as American Diabetes Association and Diabetes Technology Society meetings). Study findings may also be presented at Medical and Endocrine Grand Rounds nationally. Final data sets (i.e demographic data, medication usage data, glucometric values) will be maintained locally (VABMC server) until enterprise-level resources become available for long term storage and access.
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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. This study is not recruiting at the moment.
Ilias Spanakis, MD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GTS (Continuous Glucose Monitoring) and POC (Point of Care) in people with Diabetes Mellitus, Type 2 and Hypoglycemia, run by VA Office of Research and Development 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 2 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 7 Jan 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in hypoglycemia during the hospitalization (time frame: Through study completion-hospitalization (average length of stay at the hospital of 4-6 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03508934, which also lists 17 linked publications.
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 7 Jan 2026.