Diabete MellitusNCT03155594
CGM to Aid Transition From Inpatient to Outpatient
A study testing Freestyle Libre in people with Diabete Mellitus, run by Methodist Medical Center of Illinois at 1 site in United States.
Trial summary
A pilot study using the FreeStyle Libre to assess its potential benefits in patients with diabetes starting when they are inpatients and continuing during the transition of care to the outpatient setting to see if diabetes care can be improved after discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabete Mellitus
- What is being tested?
- Freestyle Libre
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2017to 1 Aug 2017
- 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
- Inpatients on insulin therapy 18 years and older on insulin with glucose testing 4-5 times per day
- Patient able to sign informed consent.
Who cannot join
- Patient unable to give informed consent
- Critically ill patients will not be started in the CGM patch, but he patch will not be removed if transferred to ICU.
- Patients currently on acetaminophen
- Currently on diathermy treatments
- Pregnancy
- Dialysis
Show all 9Show fewer
- Currently on vitamin C
- Patient is sensitive to the adhesive or develops significant skin irritation.
- Treatment for dehydration
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Medica Center of Illinois
Peoria, Illinois, 61602
About this study
Official title: Continuous Glucose Monitoring in the Hospital to Aid in Care and Improve Transition of Care to Outpatient
A pilot study using the FreeStyle Libre to assess its potential benefits in patients with diabetes starting when they are inpatients and continuing during the transition of care to the outpatient setting to see if diabetes care can be improved after discharge.
This study is designed to address the following questions:
- How do the glucose readings from FreeStyle Libre Pro compare to our inpatient glucometer system? Is the system is accurate enough to use for clinical decision making?
- How often does the additional continuous glucose data change inpatient care?
- Does this technology work with inpatient nursing workflow?
- Does leaving the patch on at discharge and reading in the office improve transition of care?
- Does reading the patch after discharge in the office improve follow-up care?
Read the detailed description
Continuous glucose monitoring checks blood glucose continuously. This allows the patient and provider to see what the glucose does between finger stick measurements. The FreeStyle Libre, is a sensor patch that can continuously measure glucose for up to two weeks.
Objectives To see if new continuous glucose technology can 1) Improve glucose management in the hospital compared to finger sticks 4-5 times per day. 2) Help with glucose control during transition of care from hospital to home and follow-up in the office The main hypothesis of this study is if the additional glucose information improves diabetes care for patients in the hospital and after the transition to home.
Background The FreeStyle Libre Pro was recently approved by the FDA. It is a patch applied to the skin with glucose containing sensing technology that will record the subcutaneous blood continuously for up to 2 weeks. It has the potential to reduce the number of painful glucose checks done by pricking the finger. It is currently approved for use in the office.
Study Method A pilot using the FreeStyle Libre to assess its potential benefits in patients with diabetes starting when they are inpatients and continuing during the transition of care to the outpatient setting to see if diabetes care can be improved after discharge. To our knowledge, there are currently no studies on using CGM to help the transition of care.
Protocol Outline
- Apply the FreeStyle Libre Pro to patients in the on 4-5 glucose checks per day by finger stick with insulin ordered at least 4 times per day with patient consent.
- Download the FreeStyle Libre each day and evaluate if the continuous data changes the treatment in the hospital.
- The patient will continue to wear the patch on discharge to home.
- At an after hospital office visit, the patient's data will again be downloaded and compared to finger stick glucoses done at home. Another evaluation well be done to see if this additional information changes therapy.
- Additionally, an overall evaluation will be done comparing the glucoses on the FreeStyle Libre Pro with finger stick glucoses to evaluate if the accuracy is adequate for clinical decision making.
Population Studied Estimated number of subjects: 15 Age (inclusive) Ages 18 and above Sex (estimate M:F ratio) No sexual preference The population is patients in the hospital requiring 4-5 finger stick glucoses a day and orders on insulin. Patient should also be able to follow-up in the Diabetes Clinic to download and review the information and have no contraindication to the patch such as an adhesive allergy.
Recruitment Patient consulted for diabetes management in the hospital who are on 4-5 finger stick glucoses per day and insulin will be approached.
Risks and Benefits Benefits are chance to try new method of checking blood glucose. There are potential benefits if additional information improves their care. Downloads will be reviewed and shared with patients whenever possible. Risks are pain on application of the patch and possible allergies to the adhesive. (2) others: Potential benefit is improvement in diabetes care during hospitalization and transition of care. See no downside for others.
Alternative Treatments Standard care will be provided to all patients. They are under no obligation to try the patch. The patient may discontinue the patch and drop out of the study at any time. If the patient elects to enroll in the study, information from the patch download may be used to modify the treatment. If and how often this happens is one of the study outcomes.
- Conditions
- Diabete Mellitus
- Being tested
- Freestyle Libre
- Keywords
- Diabetes, Diabetes Mellitus, Diabetes Type 1, Diabetes Type 2, CGM, Continuous Glucose Monitoring, Inpatient, Outpatient, Transition of care, DM-1, DM-2, Freestyle Libre
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freestyle LibreDevice
Continuous glucose monitoring patch
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Patients in this trial will receive a FreeStyle Libre patch that continuously measures glucose in addition to their standard glucose monitoring. Receives: Device: Freestyle Libre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in care
Each day a clinician from the Diabetes Service sees a patient in the hospital or office setting after discharge, they will download the information in the sensor patch. The clinician will note on the data collection sheet if the additional information changed the care compared to the information available from the hospital and patient glucose testing.
Measured: 2 weeks
Secondary outcomes (1)
Accuracy of device
Each glucometer glucose and serum glucose will be compared to the readings from the sensor patch.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start9 May 2017
- Primary completion15 Jul 2017 (estimated)
- Study completion1 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Diabete MellitusStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Adult patients in the hospital receiving 4-5 glucometer checks per day
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Medical Center of Illinois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Webster, APN, Methodist Medical Center of Illinois
- Investigators
- David E. Trachtenbarg, MD, Study chair, Methodist Medical Center of Illinois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155594
- Sponsor's protocol ID
- 1023056-2
- Status last verified
- May 2017
- First submitted
- 9 May 2017
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.
PubMed 28118453Bailey KJ, Little JP, Jung ME. Self-Monitoring Using Continuous Glucose Monitors with Real-Time Feedback Improves Exercise Adherence in Individuals with Impaired Blood Glucose: A Pilot Study. Diabetes Technol Ther. 2016 Mar;18(3):185-93. doi: 10.1089/dia.2015.0285. Epub 2016 Feb 17.
PubMed 26885934Sato J, Kanazawa A, Ikeda F, Shigihara N, Kawaguchi M, Komiya K, Uchida T, Ogihara T, Mita T, Shimizu T, Fujitani Y, Watada H. Effect of treatment guidance using a retrospective continuous glucose monitoring system on glycaemic control in outpatients with type 2 diabetes mellitus: A randomized controlled trial. J Int Med Res. 2016 Feb;44(1):109-21. doi: 10.1177/0300060515600190. Epub 2015 Dec 7.
PubMed 26647072De Block CE, Gios J, Verheyen N, Manuel-y-Keenoy B, Rogiers P, Jorens PG, Scuffi C, Van Gaal LF. Randomized Evaluation of Glycemic Control in the Medical Intensive Care Unit Using Real-Time Continuous Glucose Monitoring (REGIMEN Trial). Diabetes Technol Ther. 2015 Dec;17(12):889-98. doi: 10.1089/dia.2015.0151. Epub 2015 Aug 25.
PubMed 26305390Schaupp L, Donsa K, Neubauer KM, Mader JK, Aberer F, Holl B, Spat S, Augustin T, Beck P, Pieber TR, Plank J. Taking a Closer Look--Continuous Glucose Monitoring in Non-Critically Ill Hospitalized Patients with Type 2 Diabetes Mellitus Under Basal-Bolus Insulin Therapy. Diabetes Technol Ther. 2015 Sep;17(9):611-8. doi: 10.1089/dia.2014.0343. Epub 2015 Apr 30.
PubMed 25927357Kusunoki Y, Katsuno T, Nakae R, Watanabe K, Akagami T, Ochi F, Tokuda M, Murai K, Miuchi M, Miyagawa J, Namba M. Evaluation of blood glucose fluctuation in Japanese patients with type 1 diabetes mellitus by self-monitoring of blood glucose and continuous glucose monitoring. Diabetes Res Clin Pract. 2015 May;108(2):342-9. doi: 10.1016/j.diabres.2015.01.040. Epub 2015 Mar 4.
PubMed 25779865Joubert M, Fourmy C, Henri P, Ficheux M, Lobbedez T, Reznik Y. Effectiveness of continuous glucose monitoring in dialysis patients with diabetes: the DIALYDIAB pilot study. Diabetes Res Clin Pract. 2015 Mar;107(3):348-54. doi: 10.1016/j.diabres.2015.01.026. Epub 2015 Jan 21.
PubMed 25638452Kepenekian L, Smagala A, Meyer L, Imhoff O, Alenabi F, Serb L, Fleury D, Dorey F, Krummel T, Le Floch JP, Chantrel F, Kessler L. Continuous glucose monitoring in hemodialyzed patients with type 2 diabetes: a multicenter pilot study. Clin Nephrol. 2014 Oct;82(4):240-6. doi: 10.5414/CN108280.
PubMed 25161114Boom DT, Sechterberger MK, Rijkenberg S, Kreder S, Bosman RJ, Wester JP, van Stijn I, DeVries JH, van der Voort PH. Insulin treatment guided by subcutaneous continuous glucose monitoring compared to frequent point-of-care measurement in critically ill patients: a randomized controlled trial. Crit Care. 2014 Aug 20;18(4):453. doi: 10.1186/s13054-014-0453-9.
PubMed 25139609
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring in the Hospital to Aid in Care and Improve Transition of Care to Outpatient
- ClinicalTrials.gov ID
- NCT03155594
- Acronym / sponsor ID
- 1023056-2
- Conditions
- Diabete Mellitus
- Keywords
- Diabetes, Diabetes Mellitus, Diabetes Type 1, Diabetes Type 2, CGM, Continuous Glucose Monitoring, Inpatient, Outpatient
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Methodist Medical Center of IllinoisUniversity, hospital or other
- Study start
- 9 May 2017 (actual)
- Primary completion
- 15 Jul 2017 (estimated)
- Study completion
- 1 Aug 2017 (estimated)
- First posted
- 16 May 2017 (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.
A pilot study using the FreeStyle Libre to assess its potential benefits in patients with diabetes starting when they are inpatients and continuing during the transition of care to the outpatient setting to see if diabetes care can be improved after discharge.
This study is designed to address the following questions:
- How do the glucose readings from FreeStyle Libre Pro compare to our inpatient glucometer system? Is the system is accurate enough to use for clinical decision making?
- How often does the additional continuous glucose data change inpatient care?
- Does this technology work with inpatient nursing workflow?
- Does leaving the patch on at discharge and reading in the office improve transition of care?
- Does reading the patch after discharge in the office improve follow-up care?
Detailed description
Continuous glucose monitoring checks blood glucose continuously. This allows the patient and provider to see what the glucose does between finger stick measurements. The FreeStyle Libre, is a sensor patch that can continuously measure glucose for up to two weeks.
Objectives To see if new continuous glucose technology can 1) Improve glucose management in the hospital compared to finger sticks 4-5 times per day. 2) Help with glucose control during transition of care from hospital to home and follow-up in the office The main hypothesis of this study is if the additional glucose information improves diabetes care for patients in the hospital and after the transition to home.
Background The FreeStyle Libre Pro was recently approved by the FDA. It is a patch applied to the skin with glucose containing sensing technology that will record the subcutaneous blood continuously for up to 2 weeks. It has the potential to reduce the number of painful glucose checks done by pricking the finger. It is currently approved for use in the office.
Study Method A pilot using the FreeStyle Libre to assess its potential benefits in patients with diabetes starting when they are inpatients and continuing during the transition of care to the outpatient setting to see if diabetes care can be improved after discharge. To our knowledge, there are currently no studies on using CGM to help the transition of care.
Protocol Outline
- Apply the FreeStyle Libre Pro to patients in the on 4-5 glucose checks per day by finger stick with insulin ordered at least 4 times per day with patient consent.
- Download the FreeStyle Libre each day and evaluate if the continuous data changes the treatment in the hospital.
- The patient will continue to wear the patch on discharge to home.
- At an after hospital office visit, the patient's data will again be downloaded and compared to finger stick glucoses done at home. Another evaluation well be done to see if this additional information changes therapy.
- Additionally, an overall evaluation will be done comparing the glucoses on the FreeStyle Libre Pro with finger stick glucoses to evaluate if the accuracy is adequate for clinical decision making.
Population Studied Estimated number of subjects: 15 Age (inclusive) Ages 18 and above Sex (estimate M:F ratio) No sexual preference The population is patients in the hospital requiring 4-5 finger stick glucoses a day and orders on insulin. Patient should also be able to follow-up in the Diabetes Clinic to download and review the information and have no contraindication to the patch such as an adhesive allergy.
Recruitment Patient consulted for diabetes management in the hospital who are on 4-5 finger stick glucoses per day and insulin will be approached.
Risks and Benefits Benefits are chance to try new method of checking blood glucose. There are potential benefits if additional information improves their care. Downloads will be reviewed and shared with patients whenever possible. Risks are pain on application of the patch and possible allergies to the adhesive. (2) others: Potential benefit is improvement in diabetes care during hospitalization and transition of care. See no downside for others.
Alternative Treatments Standard care will be provided to all patients. They are under no obligation to try the patch. The patient may discontinue the patch and drop out of the study at any time. If the patient elects to enroll in the study, information from the patch download may be used to modify the treatment. If and how often this happens is one of the study outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Adult patients in the hospital receiving 4-5 glucometer checks per day
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: Freestyle LibrePatients in this trial will receive a FreeStyle Libre patch that continuously measures glucose in addition to their standard glucose monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Inpatients on insulin therapy 18 years and older on insulin with glucose testing 4-5 times per day
- Patient able to sign informed consent.
Key exclusion criteria (9 listed)
- Patient unable to give informed consent
- Critically ill patients will not be started in the CGM patch, but he patch will not be removed if transferred to ICU.
- Patients currently on acetaminophen
- Currently on diathermy treatments
- Pregnancy
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 LibreContinuous glucose monitoring patch | Device | Single arm |
Primary outcome
Changes in care
Time frame: 2 weeks
Each day a clinician from the Diabetes Service sees a patient in the hospital or office setting after discharge, they will download the information in the sensor patch. The clinician will note on the data collection sheet if the additional information changed the care compared to the information available from the hospital and patient glucose testing.
1 secondary outcome
Accuracy of device
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Background: PubMed 28118453Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.
- Background: PubMed 26885934Bailey KJ, Little JP, Jung ME. Self-Monitoring Using Continuous Glucose Monitors with Real-Time Feedback Improves Exercise Adherence in Individuals with Impaired Blood Glucose: A Pilot Study. Diabetes Technol Ther. 2016 Mar;18(3):185-93. doi: 10.1089/dia.2015.0285. Epub 2016 Feb 17.
- Background: PubMed 26647072Sato J, Kanazawa A, Ikeda F, Shigihara N, Kawaguchi M, Komiya K, Uchida T, Ogihara T, Mita T, Shimizu T, Fujitani Y, Watada H. Effect of treatment guidance using a retrospective continuous glucose monitoring system on glycaemic control in outpatients with type 2 diabetes mellitus: A randomized controlled trial. J Int Med Res. 2016 Feb;44(1):109-21. doi: 10.1177/0300060515600190. Epub 2015 Dec 7.
- Background: PubMed 26305390De Block CE, Gios J, Verheyen N, Manuel-y-Keenoy B, Rogiers P, Jorens PG, Scuffi C, Van Gaal LF. Randomized Evaluation of Glycemic Control in the Medical Intensive Care Unit Using Real-Time Continuous Glucose Monitoring (REGIMEN Trial). Diabetes Technol Ther. 2015 Dec;17(12):889-98. doi: 10.1089/dia.2015.0151. Epub 2015 Aug 25.
- Background: PubMed 25927357Schaupp L, Donsa K, Neubauer KM, Mader JK, Aberer F, Holl B, Spat S, Augustin T, Beck P, Pieber TR, Plank J. Taking a Closer Look--Continuous Glucose Monitoring in Non-Critically Ill Hospitalized Patients with Type 2 Diabetes Mellitus Under Basal-Bolus Insulin Therapy. Diabetes Technol Ther. 2015 Sep;17(9):611-8. doi: 10.1089/dia.2014.0343. Epub 2015 Apr 30.
- Background: PubMed 25779865Kusunoki Y, Katsuno T, Nakae R, Watanabe K, Akagami T, Ochi F, Tokuda M, Murai K, Miuchi M, Miyagawa J, Namba M. Evaluation of blood glucose fluctuation in Japanese patients with type 1 diabetes mellitus by self-monitoring of blood glucose and continuous glucose monitoring. Diabetes Res Clin Pract. 2015 May;108(2):342-9. doi: 10.1016/j.diabres.2015.01.040. Epub 2015 Mar 4.
- Background: PubMed 25638452Joubert M, Fourmy C, Henri P, Ficheux M, Lobbedez T, Reznik Y. Effectiveness of continuous glucose monitoring in dialysis patients with diabetes: the DIALYDIAB pilot study. Diabetes Res Clin Pract. 2015 Mar;107(3):348-54. doi: 10.1016/j.diabres.2015.01.026. Epub 2015 Jan 21.
- Background: PubMed 25161114Kepenekian L, Smagala A, Meyer L, Imhoff O, Alenabi F, Serb L, Fleury D, Dorey F, Krummel T, Le Floch JP, Chantrel F, Kessler L. Continuous glucose monitoring in hemodialyzed patients with type 2 diabetes: a multicenter pilot study. Clin Nephrol. 2014 Oct;82(4):240-6. doi: 10.5414/CN108280.
- Background: PubMed 25139609Boom DT, Sechterberger MK, Rijkenberg S, Kreder S, Bosman RJ, Wester JP, van Stijn I, DeVries JH, van der Voort PH. Insulin treatment guided by subcutaneous continuous glucose monitoring compared to frequent point-of-care measurement in critically ill patients: a randomized controlled trial. Crit Care. 2014 Aug 20;18(4):453. doi: 10.1186/s13054-014-0453-9.
- Device websiteLink provided by the sponsor.
- 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 E. Trachtenbarg, MD study chair
Methodist Medical Center of Illinois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freestyle Libre in people with Diabete Mellitus, run by Methodist Medical Center of Illinois 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 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2017. 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?
Results are not available in the source record.
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?
Changes in care (time frame: 2 weeks). 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 NCT03155594, which also lists 9 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 16 May 2017.