Type 2 Diabetes MellitusNCT04277780
Reducing Emergency Department Visits and Improving Glucose Control in Uncontrolled Type 2 Diabetes Using CGM Sensors at Hospital Discharge
A study testing Continuous Glucose Monitoring Sensor and Diabetes Management Instructions in people with Type 2 Diabetes Mellitus, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial summary
Quality measures and cost-reduction methods are a high priority in the United States health care system. This includes the high burden of patients with uncontrolled Type 2 Diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Continuous Glucose Monitoring Sensor and Diabetes Management Instructions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2018to 31 Dec 2020
- 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
- inpatient uncontrolled Type 2 Diabetes patients defined by HbA1c of ≥9.0% within the last 2-3 months
- require an endocrinology consultation
- will be followed at AEMC endocrinology clinic
Who cannot join
- patients with HbA1c <9.0%
- patients not managed by AEMC endocrinology clinic
- Type 1 Diabetic patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
About this study
Official title: Reducing E.D. Visits and Hospital Readmissions, and Improving Glucose Control of Patients With Uncontrolled Type 2 Diabetes by Use of Continuous Glucose Monitoring Sensors Placed at Hospital Discharge.
Quality measures and cost-reduction methods are a high priority in the United States health care system. This includes the high burden of patients with uncontrolled Type 2 Diabetes. Innovative ways to better understand and implement diabetes management plans to reduce the burden of this disease on the system are a necessity. Use of FDA-approved continuous glucose monitoring (CGM) sensors have shown benefit in better management plans in the outpatient setting. Hence, this study hypothesizes that using CGM sensors starting in the inpatient setting will provide better and quicker understanding of the disease to make expedited changes to management plans thereby improving blood glucose control and mitigating some of the health care burden by means of reducing E.D visits and hospital re-admission rates. The study will randomly assign patients to either receive a CGM sensor plus the standard diabetes management and instructions or who will only receive the standard diabetes management. The patients will be followed in the outpatient endocrinology clinic 1-month, 3-month, and 6-month from the time of hospital discharge.
Read the detailed description
Rationale: Quality measures and cost-reduction methods are a high priority in the United States health care system currently. This includes the high burden of patients with uncontrolled Type 2 Diabetes on the system especially given the continued dramatic rise in the prevalence of these patients. Innovative ways to better understand and implement diabetes management plans to reduce the burden of this disease on our health care system are a necessity. The use of continuous glucose monitoring (CGM) sensors have already shown benefit in better management plans in the outpatient setting. Hence, this study aims to assess the use of CGM sensors starting in the inpatient setting and whether they will help provide better and quicker understanding of the disease to make expedited changes to management plans thereby improving blood glucose control and mitigating some of the health care burden by means of reducing E.D visits and hospital re-admission rates.
Objectives: To determine whether the use of CGM sensors in patients with uncontrolled type 2 diabetes at the time of hospital discharge leads to improved glucose control and a reduction of E.D visits and hospital readmission rates.
Trial Design: The trial design will be a randomized, non-blinded prospective study; a 1:1 comparison of uncontrolled type 2 diabetes patients who receive CGM sensors + conventional diabetes management at the time of discharge versus uncontrolled type 2 diabetes patients who receive only the conventional diabetes management.
Study Setting: Study setting will be at the Albert Einstein Medical Center (AEMC), Philadelphia, Pennsylvania for the inpatient type 2 diabetes population who will be followed at the AEMC endocrinology clinics.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Continuous Glucose Monitoring Sensor, Diabetes Management Instructions
- Keywords
- continuous glucose monitoring sensors, hospital readmission
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitoring SensorDevice
Placement of continuous glucose monitor sensor for 14 days. Instructions on how to peel off the sensor and mail it back to the clinician.
Diabetes Management InstructionsOther
Instructions on checking fingerstick blood glucose and information on the required equipment including glucose test strips, lancets, and glucometer. Instructions on how to log blood glucose values onto the blood glucose log sheet for 14 days, and how to mail it back to the clinician.
| Study group | Role | What they receive |
|---|---|---|
| CGM Sensor | Experimental | Subjects will receive the Libre Pro Freestyle continuous glucose monitor (CGM) sensor that will be applied to their upper arm at the time of hospital discharge. They will be asked to peel off the sensor after 14 days and mail it to the endocrinology clinic in a stamped envelope that will be provided. They will also be provided the conventional diabetes management which will include instructions on fingerstick blood glucose monitoring and logging which they will start after the CGM sensor is removed. The sensor data will be analyzed by a clinician who will call the subject regarding any changes to their diabetes management. The subject will then be asked to follow-up at the endocrinology clinic 1-month, 3-month, and 6-month from the time the sensor is placed for further management of their diabetes. Receives: Device: Continuous Glucose Monitoring Sensor; Other: Diabetes Management Instructions |
| Conventional Diabetes Care | Active comparator | Subjects will receive only the conventional diabetes management at the time of hospital discharge which includes instruction on fingerstick blood glucose monitoring and logging onto a blood glucose log sheet for 14 days. They will then be asked to fax/mail/call-in the blood glucose log. The log data will be analyzed by a clinician who will call the subject regarding any changes to their diabetes management. The subject will then be asked to follow-up at the endocrinology clinic 1-month, 3-month, and 6-month from the time of hospital discharge for further management of their diabetes. Receives: Other: Diabetes Management Instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
The difference of the average changes in HbA1c from baseline between each group (intervention vs control)
Measured: Measured at the 180-day interval post-intervention
# of E.D. visits
Number of ED visits after the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Measured: Within 30 days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
# od hospital re-admissions
Number of hospital re-admissions after the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Measured: Within 30 days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Secondary outcomes (6)
Time till first E.D. Visit
Length of time until first E.D. visit from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Measured: data collected for any visit occuring within 180-days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Diabetes Mellitus (DM) Management change based on CGM sensor/log data
% of patients whose diabetes management was changed based on CGM sensor data or blood glucose log
Measured: assessed within 30 days from the time the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Time till first hypoglycemic event
Time till first hypoglycemic from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Measured: Data collected for any event occuring within 180-days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
HbA1c <9.0% at the end of study
# of patients with a HbA1c <9.0% at the end of the study compared to baseline
Measured: Assessed at the 180-day interval from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Outpatient Visit Compliance
% of patients who kept their outpatient clinic visits for diabetes (compliance)
Measured: assessed at the 180-day interval from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Severity of first hypoglycemic event
Severity of first hypoglycemic event (based on self-management vs. need call to paramedics) from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Measured: data collected for any event occuring within 180-days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start31 Oct 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: Difficulty recruiting and following more patients during Covid-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 70 patients assigned to intervention group (to receive CGM sensor + conventional diabetes management); 70 patients assigned to control group (to receive only conventional diabetes management)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Anastasopoulou, MD, PhD, FACE, Albert Einstein Healthcare Network
- Investigators
- Catherine Anastasopoulou, MD, PhD, Principal investigator, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277780
- Sponsor's protocol ID
- 5100
- Status last verified
- Apr 2021
- First submitted
- 10 Apr 2019
- Last updated
- 6 Apr 2021
- 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 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing E.D. Visits and Hospital Readmissions, and Improving Glucose Control of Patients With Uncontrolled Type 2 Diabetes by Use of Continuous Glucose Monitoring Sensors Placed at Hospital Discharge.
- ClinicalTrials.gov ID
- NCT04277780
- Acronym / sponsor ID
- 5100
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- continuous glucose monitoring sensors, hospital readmission
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting and following more patients during Covid-19 pandemic
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 20 Feb 2020 (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.
Quality measures and cost-reduction methods are a high priority in the United States health care system. This includes the high burden of patients with uncontrolled Type 2 Diabetes. Innovative ways to better understand and implement diabetes management plans to reduce the burden of this disease on the system are a necessity. Use of FDA-approved continuous glucose monitoring (CGM) sensors have shown benefit in better management plans in the outpatient setting. Hence, this study hypothesizes that using CGM sensors starting in the inpatient setting will provide better and quicker understanding of the disease to make expedited changes to management plans thereby improving blood glucose control and mitigating some of the health care burden by means of reducing E.D visits and hospital re-admission rates. The study will randomly assign patients to either receive a CGM sensor plus the standard diabetes management and instructions or who will only receive the standard diabetes management. The patients will be followed in the outpatient endocrinology clinic 1-month, 3-month, and 6-month from the time of hospital discharge.
Detailed description
Rationale: Quality measures and cost-reduction methods are a high priority in the United States health care system currently. This includes the high burden of patients with uncontrolled Type 2 Diabetes on the system especially given the continued dramatic rise in the prevalence of these patients. Innovative ways to better understand and implement diabetes management plans to reduce the burden of this disease on our health care system are a necessity. The use of continuous glucose monitoring (CGM) sensors have already shown benefit in better management plans in the outpatient setting. Hence, this study aims to assess the use of CGM sensors starting in the inpatient setting and whether they will help provide better and quicker understanding of the disease to make expedited changes to management plans thereby improving blood glucose control and mitigating some of the health care burden by means of reducing E.D visits and hospital re-admission rates.
Objectives: To determine whether the use of CGM sensors in patients with uncontrolled type 2 diabetes at the time of hospital discharge leads to improved glucose control and a reduction of E.D visits and hospital readmission rates.
Trial Design: The trial design will be a randomized, non-blinded prospective study; a 1:1 comparison of uncontrolled type 2 diabetes patients who receive CGM sensors + conventional diabetes management at the time of discharge versus uncontrolled type 2 diabetes patients who receive only the conventional diabetes management.
Study Setting: Study setting will be at the Albert Einstein Medical Center (AEMC), Philadelphia, Pennsylvania for the inpatient type 2 diabetes population who will be followed at the AEMC endocrinology clinics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 70 patients assigned to intervention group (to receive CGM sensor + conventional diabetes management); 70 patients assigned to control group (to receive only conventional diabetes management)
| Arm | Type | Receives |
|---|---|---|
| CGM Sensor | Experimental | Device: Continuous Glucose Monitoring Sensor, Other: Diabetes Management InstructionsSubjects will receive the Libre Pro Freestyle continuous glucose monitor (CGM) sensor that will be applied to their upper arm at the time of hospital discharge. They will be asked to peel off the sensor after 14 days and mail it to the endocrinology clinic in a stamped envelope that will be provided. They will also be provided the conventional diabetes management which will include instructions on fingerstick blood glucose monitoring and logging which they will start after the CGM sensor is removed. The sensor data will be analyzed by a clinician who will call the subject regarding any changes to their diabetes management. The subject will then be asked to follow-up at the endocrinology clinic 1-month, 3-month, and 6-month from the time the sensor is placed for further management of their diabetes. |
| Conventional Diabetes Care | Active comparator | Other: Diabetes Management InstructionsSubjects will receive only the conventional diabetes management at the time of hospital discharge which includes instruction on fingerstick blood glucose monitoring and logging onto a blood glucose log sheet for 14 days. They will then be asked to fax/mail/call-in the blood glucose log. The log data will be analyzed by a clinician who will call the subject regarding any changes to their diabetes management. The subject will then be asked to follow-up at the endocrinology clinic 1-month, 3-month, and 6-month from the time of hospital discharge for further management of their diabetes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- inpatient uncontrolled Type 2 Diabetes patients defined by HbA1c of ≥9.0% within the last 2-3 months
- require an endocrinology consultation
- will be followed at AEMC endocrinology clinic
Key exclusion criteria (3 listed)
- patients with HbA1c <9.0%
- patients not managed by AEMC endocrinology clinic
- Type 1 Diabetic patients
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 |
|---|---|---|
| Continuous Glucose Monitoring SensorPlacement of continuous glucose monitor sensor for 14 days. Instructions on how to peel off the sensor and mail it back to the clinician. | Device | CGM Sensor |
| Diabetes Management InstructionsInstructions on checking fingerstick blood glucose and information on the required equipment including glucose test strips, lancets, and glucometer. Instructions on how to log blood glucose values onto the blood glucose log sheet for 14 days, and how to mail it back to the clinician. | Other | CGM Sensor, Conventional Diabetes Care |
Primary outcome
Change in HbA1c
Time frame: Measured at the 180-day interval post-intervention
The difference of the average changes in HbA1c from baseline between each group (intervention vs control)
# of E.D. visits
Time frame: Within 30 days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Number of ED visits after the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
# od hospital re-admissions
Time frame: Within 30 days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Number of hospital re-admissions after the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
6 secondary outcomes
Time till first E.D. Visit
Time frame: data collected for any visit occuring within 180-days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Diabetes Mellitus (DM) Management change based on CGM sensor/log data
Time frame: assessed within 30 days from the time the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Time till first hypoglycemic event
Time frame: Data collected for any event occuring within 180-days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
HbA1c <9.0% at the end of study
Time frame: Assessed at the 180-day interval from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Outpatient Visit Compliance
Time frame: assessed at the 180-day interval from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Severity of first hypoglycemic event
Time frame: data collected for any event occuring within 180-days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Results and safety
The study was stopped early (reason given: Difficulty recruiting and following more patients during Covid-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- 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.
Catherine Anastasopoulou, MD, PhD principal investigator
Albert Einstein Healthcare Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitoring Sensor and Diabetes Management Instructions in people with Type 2 Diabetes Mellitus, run by Albert Einstein Healthcare Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 6 Apr 2021. 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?
The study was stopped early (reason given: Difficulty recruiting and following more patients during Covid-19 pandemic). 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?
Change in HbA1c (time frame: Measured at the 180-day interval post-intervention). The study lists 3 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 6 Apr 2021.