Diabetes Mellitus, Type 2NCT05822232
FreeStyle Libre 2 Discharge Trial
A study testing FreeStyle Libre 2 CGM, FreeStyle Libre Pro blinded CGM and FreeStyle Precision Neo blood glucose meter in people with Diabetes Mellitus, Type 2 and Hypoglycemia, run by Palo Alto Medical Foundation at 2 sites in United States.
Trial summary
The goal of this clinical trial is to learn about the benefits of using aa Continuous Glucose Monitoring (CGM) system in patients with diabetes following discharge from the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypoglycemia
- What is being tested?
- FreeStyle Libre 2 CGM, FreeStyle Libre Pro blinded CGM and FreeStyle Precision Neo blood glucose meter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Aug 2022to 30 Apr 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
- 1. Males and females ≥18 years of age admitted to general medicine and surgery services.
- 2. Known history of T2D treated with oral antidiabetic agents (sulfonylureas, meglitinides, alpha-glucosidase inhibitors, thiazolidinedione, DPP-4 inhibitors, SGLT2- inhibitors), GLP1-RAs (exenatide, liraglutide, dulaglutide, semaglutide) or 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.
- 3. Discharged on insulin therapy consisting of basal therapy 1) with or without bolus insulin and also 2) with or without other diabetes drugs.
Who cannot join
- 1. Subjects admitted with a diagnosis of diabetic ketoacidosis or hyperosmolar hyperglycemic state.
- 2. Subjects using CGM technology prior to admission
- 3. Subjects with type 1 diabetes
- 4. Subjects not willing to receive insulin injections or test POC 4 times daily
- 5. Subjects discharged from the hospital on diabetes therapy that does not include basal insulin.
- 6. Subjects not willing to wear a CGM device
Show all 10Show fewer
- 7. Pregnant women
- 8. Subjects with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension) and end-stage kidney disease (eGFR< 30 ml/min), dialysis, critically ill or terminal illness.
- 9. Subjects with history of cognitive impairment, dementia, or mental condition rendering the subject unable to understand the nature and consequences of the study.
- 10. Subjects expected to be readmitted to the hospital within 3 months post-discharge.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Division of Endocrinology, Department of Medicine, Emory University School of Medicine
Atlanta, Georgia, 30322
Bobak Moazzami, MD, 404-251-8963, bobak.moazzami@emory.edu
Guillermo E Umpierrez, MD
- Recruiting
Palo Alto Medical Foundation Research Institute
Palo Alto, California, 94301
Irina Nayberg, RN, 650-696-4261, Irina.Nayberg@sutterhealth.org
Jimmin Chang, PhD, RN, +1(650)853-5645, Jimmin.Chang@sutterhealth.org
About this study
Official title: A Randomized Controlled Trial Comparing the FreeStyle Libre 2 Continuous Glucose Monitoring vs Point of Care Glucose Testing for the Management of Subjects With Type 2 Diabetes After Hospital Discharge: FreeStyle Libre 2 Discharge Trial
The goal of this clinical trial is to learn about the benefits of using aa Continuous Glucose Monitoring (CGM) system in patients with diabetes following discharge from the hospital. The main question it aims to answer is:
- If the use of CGM with alarms is safe and effective for managing low and/or high blood sugars when compared with performing finger sticks several times per day
Read more
Participants will wear one or two FreeStyle Libre CGM sensors for 12-14 days three times over a 12-week (3 month) period. This means that they will have the one to two sensors inserted under their skin. They will be asked to come to the study site four times and complete two phone calls with research staff over the 12-week period.
Researchers will compare the LibreView CGM group to the Standard of Care group to see if the use of continuous glucose monitoring (CGM) reduces risk of low blood sugar in patients with type 2 diabetes (T2D) after hospital discharge when compared with the current standard method.
Read the detailed description
The purpose of this study is to look at the benefits of using Continuous Glucose Monitoring (CGM) system for patients with diabetes following discharge from the hospital. CGM devices measure blood sugar every few minutes using a sensor inserted under the skin.
In this study, we will compare the CGM method to the current usual (standard-of-care) method, which involves taking blood samples by fingerstick before meals and at bedtime. The CGM system recognizes low and high blood sugars throughout the day and night. The CGM system used in this study also has an alarm feature that alerts the user if blood sugar levels are too high or too low. In this study we will test if the use of CGM with alarms is safe and effective for managing low and/or high blood sugars when compared with performing finger sticks several times per day, which some diabetes patients find painful and burdensome.
In this study, 50% of participants will use the CGM method and 50% will use the fingerstick method to measure and control their glucose. The researchers will compare the two groups to answer the question if the use of continuous glucose monitoring (CGM) reduces risk of low blood sugar in patients with type 2 diabetes (T2D) after hospital discharge when compared with the current standard method.
- Conditions
- Diabetes Mellitus, Type 2, Hypoglycemia
- Being tested
- FreeStyle Libre 2 CGM, FreeStyle Libre Pro blinded CGM, FreeStyle Precision Neo blood glucose meter
- Keywords
- Hospital discharge, algorithm, CGM, technology, type 2 diabetes, hospital hyperglycemia
- 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.
FreeStyle Libre 2 CGMDevice
FreeStyle Libre 2 CGM is FDA-approved and will be used according to FDA-approved labeling
FreeStyle Libre Pro blinded CGMDevice
FreeStyle Libre Pro blinded CGM is FDA-approved and will be used according to FDA-approved labeling
FreeStyle Precision Neo blood glucose meterDevice
FreeStyle Precision Neo blood glucose meter is FDA-approved and will be used according to FDA-approved labeling
| Study group | Role | What they receive |
|---|---|---|
| FreeStyle Libre 2 | Active comparator | Subjects randomized to Group 1: FreeStyle Libre 2 will wear two FreeStyle Libre CGM sensors for 12-14 days three times over a 12-week (3 month) period. They will have two sensors inserted under their skin:
FreeStyle Libre 2 sensor with display on, meaning they will be able to see their blood sugar values on the mobile application or a reader.
FreeStyle Libre Pro sensor is used without mobile application or reader. This sensor is place as a backup in case the information is missing from the Libre 2 sensor. Receives: Device: FreeStyle Libre 2 CGM; Device: FreeStyle Libre Pro blinded CGM |
| Point of Care (POC) Self-Monitoring of Blood Glucose (SMBG) testing | Active comparator | Subjects randomized to Group 2: Point of Care (POC) Self-Monitoring of Blood Glucose (SMBG) testing will wear one FreeStyle Libre Pro CGM sensor without using the mobile application or reader (blinded). These subjects will have the one sensor inserted under their skin but you will not see sugar values on the CGM. Subjects will wear the CGM for 12-14 days three times over a 12-week (3 month) period but will not use the CGM to monitor and control their blood sugar. Instead, they will monitor their sugar values by the standard method of fingerstick before each meal and at bedtime. Receives: Device: FreeStyle Libre Pro blinded CGM; Device: FreeStyle Precision Neo blood glucose meter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint
Frequency of overall and nocturnal hypoglycemia (< 70 mg/dl) by capillary POC testing and by FreeStyle Libre 2 CGM
Measured: 2 weeks
Safety Endpoint
Frequency of overall and nocturnal hypoglycemia (< 70 mg/dl) by capillary POC testing and by FreeStyle Libre 2 CGM
Measured: 4 weeks
Safety Endpoint
Frequency of overall and nocturnal hypoglycemia (< 70 mg/dl) by capillary POC testing and by FreeStyle Libre 2 CGM
Measured: 12 weeks
Efficacy endpoint
Glycemic control, as measured by mean daily glucose concentration between groups by capillary POC testing and by CGM
Measured: 2 weeks
Efficacy endpoint
Glycemic control, as measured by mean daily glucose concentration between groups by capillary POC testing and by CGM
Measured: 4 weeks
Efficacy endpoint
Glycemic control, as measured by mean daily glucose concentration between groups by capillary POC testing and by CGM
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start17 Aug 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palo Alto Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Diabetes Care, Emory University
- Responsible party
- Sponsor
- Investigators
- David Klonoff, MD, Principal investigator, Sutter Health, Diabetes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822232
- Sponsor's protocol ID
- 2022.050-2
- Status last verified
- Apr 2023
- First submitted
- 1 Dec 2022
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the FreeStyle Libre 2 Continuous Glucose Monitoring vs Point of Care Glucose Testing for the Management of Subjects With Type 2 Diabetes After Hospital Discharge: FreeStyle Libre 2 Discharge Trial
- ClinicalTrials.gov ID
- NCT05822232
- Acronym / sponsor ID
- 2022.050-2
- Conditions
- Diabetes Mellitus, Type 2, Hypoglycemia
- Keywords
- Hospital discharge, algorithm, CGM, technology, type 2 diabetes, hospital hyperglycemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Palo Alto Medical FoundationUniversity, hospital or other
- Collaborators
- Abbott Diabetes Care, Emory University
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 20 Apr 2023 (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.
The goal of this clinical trial is to learn about the benefits of using aa Continuous Glucose Monitoring (CGM) system in patients with diabetes following discharge from the hospital. The main question it aims to answer is:
- If the use of CGM with alarms is safe and effective for managing low and/or high blood sugars when compared with performing finger sticks several times per day
Participants will wear one or two FreeStyle Libre CGM sensors for 12-14 days three times over a 12-week (3 month) period. This means that they will have the one to two sensors inserted under their skin. They will be asked to come to the study site four times and complete two phone calls with research staff over the 12-week period.
Researchers will compare the LibreView CGM group to the Standard of Care group to see if the use of continuous glucose monitoring (CGM) reduces risk of low blood sugar in patients with type 2 diabetes (T2D) after hospital discharge when compared with the current standard method.
Detailed description
The purpose of this study is to look at the benefits of using Continuous Glucose Monitoring (CGM) system for patients with diabetes following discharge from the hospital. CGM devices measure blood sugar every few minutes using a sensor inserted under the skin.
In this study, we will compare the CGM method to the current usual (standard-of-care) method, which involves taking blood samples by fingerstick before meals and at bedtime. The CGM system recognizes low and high blood sugars throughout the day and night. The CGM system used in this study also has an alarm feature that alerts the user if blood sugar levels are too high or too low. In this study we will test if the use of CGM with alarms is safe and effective for managing low and/or high blood sugars when compared with performing finger sticks several times per day, which some diabetes patients find painful and burdensome.
In this study, 50% of participants will use the CGM method and 50% will use the fingerstick method to measure and control their glucose. The researchers will compare the two groups to answer the question if the use of continuous glucose monitoring (CGM) reduces risk of low blood sugar in patients with type 2 diabetes (T2D) after hospital discharge when compared with the current standard method.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FreeStyle Libre 2 | Active comparator | Device: FreeStyle Libre 2 CGM, Device: FreeStyle Libre Pro blinded CGMSubjects randomized to Group 1: FreeStyle Libre 2 will wear two FreeStyle Libre CGM sensors for 12-14 days three times over a 12-week (3 month) period. They will have two sensors inserted under their skin: FreeStyle Libre 2 sensor with display on, meaning they will be able to see their blood sugar values on the mobile application or a reader. FreeStyle Libre Pro sensor is used without mobile application or reader. This sensor is place as a backup in case the information is missing from the Libre 2 sensor. |
| Point of Care (POC) Self-Monitoring of Blood Glucose (SMBG) testing | Active comparator | Device: FreeStyle Libre Pro blinded CGM, Device: FreeStyle Precision Neo blood glucose meterSubjects randomized to Group 2: Point of Care (POC) Self-Monitoring of Blood Glucose (SMBG) testing will wear one FreeStyle Libre Pro CGM sensor without using the mobile application or reader (blinded). These subjects will have the one sensor inserted under their skin but you will not see sugar values on the CGM. Subjects will wear the CGM for 12-14 days three times over a 12-week (3 month) period but will not use the CGM to monitor and control their blood sugar. Instead, they will monitor their sugar values by the standard method of fingerstick before each meal and at bedtime. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Males and females ≥18 years of age admitted to general medicine and surgery services.
- 2. Known history of T2D treated with oral antidiabetic agents (sulfonylureas, meglitinides, alpha-glucosidase inhibitors, thiazolidinedione, DPP-4 inhibitors, SGLT2- inhibitors), GLP1-RAs (exenatide, liraglutide, dulaglutide, semaglutide) or 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.
- 3. Discharged on insulin therapy consisting of basal therapy 1) with or without bolus insulin and also 2) with or without other diabetes drugs.
Key exclusion criteria (10 listed)
- 1. Subjects admitted with a diagnosis of diabetic ketoacidosis or hyperosmolar hyperglycemic state.
- 2. Subjects using CGM technology prior to admission
- 3. Subjects with type 1 diabetes
- 4. Subjects not willing to receive insulin injections or test POC 4 times daily
- 5. Subjects discharged from the hospital on diabetes therapy that does not include basal insulin.
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 |
|---|---|---|
| FreeStyle Libre 2 CGMFreeStyle Libre 2 CGM is FDA-approved and will be used according to FDA-approved labeling | Device | FreeStyle Libre 2 |
| FreeStyle Libre Pro blinded CGMFreeStyle Libre Pro blinded CGM is FDA-approved and will be used according to FDA-approved labeling | Device | FreeStyle Libre 2, Point of Care (POC) Self-Monitoring of Blood Glucose (SMBG) testing |
| FreeStyle Precision Neo blood glucose meterFreeStyle Precision Neo blood glucose meter is FDA-approved and will be used according to FDA-approved labeling | Device | Point of Care (POC) Self-Monitoring of Blood Glucose (SMBG) testing |
Primary outcome
Safety Endpoint
Time frame: 2 weeks
Frequency of overall and nocturnal hypoglycemia (< 70 mg/dl) by capillary POC testing and by FreeStyle Libre 2 CGM
Safety Endpoint
Time frame: 4 weeks
Frequency of overall and nocturnal hypoglycemia (< 70 mg/dl) by capillary POC testing and by FreeStyle Libre 2 CGM
Safety Endpoint
Time frame: 12 weeks
Frequency of overall and nocturnal hypoglycemia (< 70 mg/dl) by capillary POC testing and by FreeStyle Libre 2 CGM
Efficacy endpoint
Time frame: 2 weeks
Glycemic control, as measured by mean daily glucose concentration between groups by capillary POC testing and by CGM
Efficacy endpoint
Time frame: 4 weeks
Glycemic control, as measured by mean daily glucose concentration between groups by capillary POC testing and by CGM
Efficacy endpoint
Time frame: 12 weeks
Glycemic control, as measured by mean daily glucose concentration between groups by capillary POC testing and by CGM
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- 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. This study is not recruiting at the moment.
David Klonoff, MD principal investigator
Sutter Health, Diabetes Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeStyle Libre 2 CGM, FreeStyle Libre Pro blinded CGM and FreeStyle Precision Neo blood glucose meter in people with Diabetes Mellitus, Type 2 and Hypoglycemia, run by Palo Alto Medical Foundation at 2 sites 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 10 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: status not confirmed, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veronica Luna (650-853-4941, Veronica.Luna@sutterhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoint (time frame: 2 weeks). 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 20 Apr 2023.