Diabetes Mellitus Type 2NCT06607224
Effect of the Use of Continuous Glucose Monitoring Versus Standard Glycemic Control in Hospitalized Patients with Type 2 Diabetes.
A study testing Experimental (Decision making guided by CGM) in people with Diabetes Mellitus Type 2 and Hospitalization, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
Type 2 diabetes (T2D) is a common pathology in hospitalized patients and is associated with multiple comorbidities. Moreover, it is widely known that glycemic excursions increase hospital stay, infections, morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2, Hospitalization
- What is being tested?
- Experimental (Decision making guided by CGM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2022to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Over 18 years old
- Admitted to medical or surgical wards with an expected hospitalization duration of more than 72 hours
- Requiring basal-bolus insulin therapy during hospitalization.
Who cannot join
- Pregnant women
- Severe mental illnesses
- Chronic use of high doses of ascorbic acid (equivalent to more than 500mg/day)
- Patients hospitalized in Intensive Care Units
- Severe cognitive impairment
- Prior outpatient CGM use
- Refusal of informed consent
- Patients on prolonged absolute diets or receiving artificial nutrition
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
About this study
Official title: Effect of the Use of Continuous Glucose Monitoring Versus Standard Glycemic Control for Insulin Therapy Adjustment and Decision Making in Noncritical Patients with Type 2 Diabetes Hospitalized in Medical and Surgical Wards.
Type 2 diabetes (T2D) is a common pathology in hospitalized patients and is associated with multiple comorbidities. Moreover, it is widely known that glycemic excursions increase hospital stay, infections, morbidity and mortality. Likewise, asymptomatic hypoglycemia and stress hyperglycemia in hospitalized patients is more frequent due to intercurrent pathology, medication, alteration of counter-regulatory hormones. Therefore, the use of continuous glucose monitoring (CGM) systems would be very useful as it allows early recognition of glycemic excursions and thus improve the management of insulin therapy. The primary objective is to demonstrate the increase in time in range (TIR) with the use of CGM for insulin therapy adjustment in hospitalized patients with T2D during their admission. The investigators randomized, parallel group, 2-arm, 40 participants; 20 in each group, patients with diagnosis of T2D prior to admission.
Read the detailed description
Over the past few decades advances in diabetes technology have revolutionized patient care and metabolic control. The use of CGM has demonstrated substantial benefits on glycemic control in ambulatory patients compared to standard capillary blood glucose (CG) monitoring. However, in hospitalized patients, limitations on its use persist due to the lack of standardization of the data provided by CGM.
The use of CG has been the mainstay for monitoring and adjusting the treatment of hospitalized patients with diabetes. In the management for inpatients this test is commonly performed 3 to 4 times a day. However, this provides significant limitations due to its intermittent nature and the associated time burden for hospital nursing and ancillary staff for its determination.
Several studies have demonstrated that CGM detects more hyperglycemia and hypoglycemia in critically ill and non-critically ill patients. These studies have provided important information on patterns of glycemic control, with emphasis on early detection of glycemic excursions. However, there is still a need for further research to determine the efficacy of their use in glycemic adjustment, reliability in the hospital setting, and standardized protocols for their implementation and decision-making.
HYPOTHESIS The use of CGM allows an increase in TIR and improves the detection of clinically significant hypoglycemia and hyperglycemia in patients with T2D hospitalized on basal-bolus insulin therapy versus standard CG.
- Conditions
- Diabetes Mellitus Type 2, Hospitalization
- Being tested
- Experimental (Decision making guided by CGM)
- Keywords
- continuous glucose monitoring, hyperglycemia, FreeStyle, Hospitalization, Time in range
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental (Decision making guided by CGM)Device
Also called CGM
Patients use FSL2 and a smartphone. Libreview app will be used to assess interstitial glucose, alarms, and trend arrows, and LibreLinkUp app for research team. Concurrently, CG will be performed using the FreeStyle Optium Neo glucometer from Abbott. The nursing staff will be trained to manage and respond to alarms and trend arrows according to established protocols. The basal insulin adjustment protocol establishes with fasting and premeal targets between 140-180 mg/dL. For prandial insulin, corrective guidelines set according to each patient sensitivity factor, with additional adjustments for the intervention group based on trend arrows. The hypoglycemia alarm sets below 85 mg/dL. If activated, nursing staff will confirm the value via CG. If values are below 70 mg/dL, follow hypoglycemia protocol and if below 100 mg/dL with a descending trend arrow, 15 grams of slow-acting carbs. The hyperglycemia alarm will be set above 300 mg/dL and nurse inform investigators to make decisions.
| Study group | Role | What they receive |
|---|---|---|
| Decision making guided by CGM | Experimental | Hospitalized patients with T2D in non-critical medical and surgical wards. The participants use FreeStyle 2-CGM and therapeutic decisions will be made based on CGM and GC parameters; with the presence of alarms for hypoglycemia or hyperglycemia activated for timely action. Blinded will be applied to patients; while the data will be open to the physicians in charge of the research in order to make daily modifications of insulin therapy. The CG controls will be of 6 points (before each meal and two hours after meals) with a standard Abbott FreeStyle Optium Neo glucometer. Basal-bolus scheme with basal insulin Glargine U-100 and prandial insulin Aspart will be used. Daily adjustments will be made based on protocol based of our department according to the international guidelines and previous research Receives: Device: Experimental (Decision making guided by CGM) |
| Decision making guided by CG | No intervention | Hospitalized patients with T2D admitted in non-critical medical and surgical wards. The participants use FreeStyle 2-CGM with deactivated alarms. Blind will be applied for patients, nurses and physicians in charge of the investigation. Concomitant 6-point CG controls will be performed (before each meal and two hours after meals) with Abbott FreeStyle Optium Neo glucometer. Insulin therapy adjustments will be carried out by GC only. The CGM values in this group will be evaluated a posteriori. Basal-bolus schedule with basal insulin Glargine U-100 and prandial insulin Aspart will be used. Daily adjustments will be made based on protocols of our department according to the international guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to demonstrate the increase in TIR with the use of CGM for insulin therapy adjustment in hospitalized patients with T2D during their admission.
-Time in range (TIR) reported at the end of sensor use: results will be expressed in percentages and levels greater than 70% will be considered good glycemic control.
Measured: The days of sensor use during hospitalization (from 3 to 14 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start10 Jan 2022
- Primary completion1 Nov 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Gonzalez Albarran, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607224
- Sponsor's protocol ID
- ENDO2021-1
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Spanakis EK, Urrutia A, Galindo RJ, Vellanki P, Migdal AL, Davis G, Fayfman M, Idrees T, Pasquel FJ, Coronado WZ, Albury B, Moreno E, Singh LG, Marcano I, Lizama S, Gothong C, Munir K, Chesney C, Maguire R, Scott WH, Perez-Guzman MC, Cardona S, Peng L, Umpierrez GE. Continuous Glucose Monitoring-Guided Insulin Administration in Hospitalized Patients With Diabetes: A Randomized Clinical Trial. Diabetes Care. 2022 Oct 1;45(10):2369-2375. doi: 10.2337/dc22-0716.
PubMed 35984478Fortmann AL, Spierling Bagsic SR, Talavera L, Garcia IM, Sandoval H, Hottinger A, Philis-Tsimikas A. Glucose as the Fifth Vital Sign: A Randomized Controlled Trial of Continuous Glucose Monitoring in a Non-ICU Hospital Setting. Diabetes Care. 2020 Nov;43(11):2873-2877. doi: 10.2337/dc20-1016. Epub 2020 Aug 27.
PubMed 32855160Burt MG, Roberts GW, Aguilar-Loza NR, Stranks SN. Brief report: Comparison of continuous glucose monitoring and finger-prick blood glucose levels in hospitalized patients administered basal-bolus insulin. Diabetes Technol Ther. 2013 Mar;15(3):241-5. doi: 10.1089/dia.2012.0282. Epub 2013 Jan 29.
PubMed 23360391Wallia A, Umpierrez GE, Rushakoff RJ, Klonoff DC, Rubin DJ, Hill Golden S, Cook CB, Thompson B; DTS Continuous Glucose Monitoring in the Hospital Panel. Consensus Statement on Inpatient Use of Continuous Glucose Monitoring. J Diabetes Sci Technol. 2017 Sep;11(5):1036-1044. doi: 10.1177/1932296817706151. Epub 2017 Apr 21.
PubMed 28429611Umpierrez GE, Klonoff DC. Diabetes Technology Update: Use of Insulin Pumps and Continuous Glucose Monitoring in the Hospital. Diabetes Care. 2018 Aug;41(8):1579-1589. doi: 10.2337/dci18-0002. Epub 2018 Jun 23.
PubMed 29936424Gomez AM, Umpierrez GE, Munoz OM, Herrera F, Rubio C, Aschner P, Buendia R. Continuous Glucose Monitoring Versus Capillary Point-of-Care Testing for Inpatient Glycemic Control in Type 2 Diabetes Patients Hospitalized in the General Ward and Treated With a Basal Bolus Insulin Regimen. J Diabetes Sci Technol. 2015 Aug 31;10(2):325-9. doi: 10.1177/1932296815602905.
PubMed 26330394Spanakis EK, Cook CB, Kulasa K, Aloi JA, Bally L, Davis G, Dungan KM, Galindo RJ, Mendez CE, Pasquel FJ, Shah VN, Umpierrez GE, Aaron RE, Tian T, Yeung AM, Huang J, Klonoff DC. A Consensus Statement for Continuous Glucose Monitoring Metrics for Inpatient Clinical Trials. J Diabetes Sci Technol. 2023 Nov;17(6):1527-1552. doi: 10.1177/19322968231191104. Epub 2023 Aug 17.
PubMed 37592726
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Use of Continuous Glucose Monitoring Versus Standard Glycemic Control for Insulin Therapy Adjustment and Decision Making in Noncritical Patients with Type 2 Diabetes Hospitalized in Medical and Surgical Wards.
- ClinicalTrials.gov ID
- NCT06607224
- Acronym / sponsor ID
- ENDO2021-1
- Conditions
- Diabetes Mellitus Type 2, Hospitalization
- Keywords
- continuous glucose monitoring, hyperglycemia, FreeStyle, Hospitalization, Time in range
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 23 Sep 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.
Type 2 diabetes (T2D) is a common pathology in hospitalized patients and is associated with multiple comorbidities. Moreover, it is widely known that glycemic excursions increase hospital stay, infections, morbidity and mortality. Likewise, asymptomatic hypoglycemia and stress hyperglycemia in hospitalized patients is more frequent due to intercurrent pathology, medication, alteration of counter-regulatory hormones. Therefore, the use of continuous glucose monitoring (CGM) systems would be very useful as it allows early recognition of glycemic excursions and thus improve the management of insulin therapy. The primary objective is to demonstrate the increase in time in range (TIR) with the use of CGM for insulin therapy adjustment in hospitalized patients with T2D during their admission. The investigators randomized, parallel group, 2-arm, 40 participants; 20 in each group, patients with diagnosis of T2D prior to admission.
Detailed description
Over the past few decades advances in diabetes technology have revolutionized patient care and metabolic control. The use of CGM has demonstrated substantial benefits on glycemic control in ambulatory patients compared to standard capillary blood glucose (CG) monitoring. However, in hospitalized patients, limitations on its use persist due to the lack of standardization of the data provided by CGM.
The use of CG has been the mainstay for monitoring and adjusting the treatment of hospitalized patients with diabetes. In the management for inpatients this test is commonly performed 3 to 4 times a day. However, this provides significant limitations due to its intermittent nature and the associated time burden for hospital nursing and ancillary staff for its determination.
Several studies have demonstrated that CGM detects more hyperglycemia and hypoglycemia in critically ill and non-critically ill patients. These studies have provided important information on patterns of glycemic control, with emphasis on early detection of glycemic excursions. However, there is still a need for further research to determine the efficacy of their use in glycemic adjustment, reliability in the hospital setting, and standardized protocols for their implementation and decision-making.
HYPOTHESIS The use of CGM allows an increase in TIR and improves the detection of clinically significant hypoglycemia and hyperglycemia in patients with T2D hospitalized on basal-bolus insulin therapy versus standard CG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision making guided by CGM | Experimental | Device: Experimental (Decision making guided by CGM)Hospitalized patients with T2D in non-critical medical and surgical wards. The participants use FreeStyle 2-CGM and therapeutic decisions will be made based on CGM and GC parameters; with the presence of alarms for hypoglycemia or hyperglycemia activated for timely action. Blinded will be applied to patients; while the data will be open to the physicians in charge of the research in order to make daily modifications of insulin therapy. The CG controls will be of 6 points (before each meal and two hours after meals) with a standard Abbott FreeStyle Optium Neo glucometer. Basal-bolus scheme with basal insulin Glargine U-100 and prandial insulin Aspart will be used. Daily adjustments will be made based on protocol based of our department according to the international guidelines and previous research |
| Decision making guided by CG | No intervention | –Hospitalized patients with T2D admitted in non-critical medical and surgical wards. The participants use FreeStyle 2-CGM with deactivated alarms. Blind will be applied for patients, nurses and physicians in charge of the investigation. Concomitant 6-point CG controls will be performed (before each meal and two hours after meals) with Abbott FreeStyle Optium Neo glucometer. Insulin therapy adjustments will be carried out by GC only. The CGM values in this group will be evaluated a posteriori. Basal-bolus schedule with basal insulin Glargine U-100 and prandial insulin Aspart will be used. Daily adjustments will be made based on protocols of our department according to the international guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years old
- Admitted to medical or surgical wards with an expected hospitalization duration of more than 72 hours
- Requiring basal-bolus insulin therapy during hospitalization.
Key exclusion criteria (8 listed)
- Pregnant women
- Severe mental illnesses
- Chronic use of high doses of ascorbic acid (equivalent to more than 500mg/day)
- Patients hospitalized in Intensive Care Units
- Severe cognitive impairment
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 |
|---|---|---|
| Experimental (Decision making guided by CGM)Also: CGMPatients use FSL2 and a smartphone. Libreview app will be used to assess interstitial glucose, alarms, and trend arrows, and LibreLinkUp app for research team. Concurrently, CG will be performed using the FreeStyle Optium Neo glucometer from Abbott. The nursing staff will be trained to manage and respond to alarms and trend arrows according to established protocols. The basal insulin adjustment protocol establishes with fasting and premeal targets between 140-180 mg/dL. For prandial insulin, corrective guidelines set according to each patient sensitivity factor, with additional adjustments for the intervention group based on trend arrows. The hypoglycemia alarm sets below 85 mg/dL. If activated, nursing staff will confirm the value via CG. If values are below 70 mg/dL, follow hypoglycemia protocol and if below 100 mg/dL with a descending trend arrow, 15 grams of slow-acting carbs. The hyperglycemia alarm will be set above 300 mg/dL and nurse inform investigators to make decisions. | Device | Decision making guided by CGM |
Primary outcome
The primary objective is to demonstrate the increase in TIR with the use of CGM for insulin therapy adjustment in hospitalized patients with T2D during their admission.
Time frame: The days of sensor use during hospitalization (from 3 to 14 days).
-Time in range (TIR) reported at the end of sensor use: results will be expressed in percentages and levels greater than 70% will be considered good glycemic control.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Background: PubMed 35984478Spanakis EK, Urrutia A, Galindo RJ, Vellanki P, Migdal AL, Davis G, Fayfman M, Idrees T, Pasquel FJ, Coronado WZ, Albury B, Moreno E, Singh LG, Marcano I, Lizama S, Gothong C, Munir K, Chesney C, Maguire R, Scott WH, Perez-Guzman MC, Cardona S, Peng L, Umpierrez GE. Continuous Glucose Monitoring-Guided Insulin Administration in Hospitalized Patients With Diabetes: A Randomized Clinical Trial. Diabetes Care. 2022 Oct 1;45(10):2369-2375. doi: 10.2337/dc22-0716.
- Background: PubMed 32855160Fortmann AL, Spierling Bagsic SR, Talavera L, Garcia IM, Sandoval H, Hottinger A, Philis-Tsimikas A. Glucose as the Fifth Vital Sign: A Randomized Controlled Trial of Continuous Glucose Monitoring in a Non-ICU Hospital Setting. Diabetes Care. 2020 Nov;43(11):2873-2877. doi: 10.2337/dc20-1016. Epub 2020 Aug 27.
- Background: PubMed 23360391Burt MG, Roberts GW, Aguilar-Loza NR, Stranks SN. Brief report: Comparison of continuous glucose monitoring and finger-prick blood glucose levels in hospitalized patients administered basal-bolus insulin. Diabetes Technol Ther. 2013 Mar;15(3):241-5. doi: 10.1089/dia.2012.0282. Epub 2013 Jan 29.
- Background: PubMed 28429611Wallia A, Umpierrez GE, Rushakoff RJ, Klonoff DC, Rubin DJ, Hill Golden S, Cook CB, Thompson B; DTS Continuous Glucose Monitoring in the Hospital Panel. Consensus Statement on Inpatient Use of Continuous Glucose Monitoring. J Diabetes Sci Technol. 2017 Sep;11(5):1036-1044. doi: 10.1177/1932296817706151. Epub 2017 Apr 21.
- Background: PubMed 29936424Umpierrez GE, Klonoff DC. Diabetes Technology Update: Use of Insulin Pumps and Continuous Glucose Monitoring in the Hospital. Diabetes Care. 2018 Aug;41(8):1579-1589. doi: 10.2337/dci18-0002. Epub 2018 Jun 23.
- Background: PubMed 26330394Gomez AM, Umpierrez GE, Munoz OM, Herrera F, Rubio C, Aschner P, Buendia R. Continuous Glucose Monitoring Versus Capillary Point-of-Care Testing for Inpatient Glycemic Control in Type 2 Diabetes Patients Hospitalized in the General Ward and Treated With a Basal Bolus Insulin Regimen. J Diabetes Sci Technol. 2015 Aug 31;10(2):325-9. doi: 10.1177/1932296815602905.
- Background: PubMed 37592726Spanakis EK, Cook CB, Kulasa K, Aloi JA, Bally L, Davis G, Dungan KM, Galindo RJ, Mendez CE, Pasquel FJ, Shah VN, Umpierrez GE, Aaron RE, Tian T, Yeung AM, Huang J, Klonoff DC. A Consensus Statement for Continuous Glucose Monitoring Metrics for Inpatient Clinical Trials. J Diabetes Sci Technol. 2023 Nov;17(6):1527-1552. doi: 10.1177/19322968231191104. Epub 2023 Aug 17.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental (Decision making guided by CGM) in people with Diabetes Mellitus Type 2 and Hospitalization, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
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 8 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: finished, as of the sponsor's last update on 23 Sep 2024. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary objective is to demonstrate the increase in TIR with the use of CGM for insulin therapy adjustment in hospitalized patients with T2D during their admission. (time frame: The days of sensor use during hospitalization (from 3 to 14 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 NCT06607224, which also lists 7 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 23 Sep 2024.