Diabetes MellitusGOOD-ERNCT05197829

Glycemic Optimization On Discharge From the Emergency Room

A study testing Continuous Glucose Monitoring and Care Coordination in people with Diabetes Mellitus, run by Mark O'Connor at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Continuous glucose monitors can help people with diabetes avoid blood sugar levels that are either dangerously high or low. This study evaluates whether continuous glucose monitoring after discharge from the emergency room can help people with type 1 or type 2 diabetes avoid repeat emergency room visits, achieve… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus
What is being tested?: Continuous Glucose Monitoring and Care Coordination
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 5 Jan 2022to 5 Jan 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Seen in the Emergency Department for hypo- or hyperglycemia
Either an existing diabetes center patient or a new referral
Type 1 or type 2 diabetes
Able to provide informed consent
Fluent in English or Spanish

Who cannot join

Current CGM use
Need for hospital admission
Upcoming CT or MRI within 2 weeks
Pregnancy
Altered mental status
Not appropriate for diabetes center follow up
Prisoners

Trial locations and contacts

1 site in 1 country.

United States1 site

UMass Memorial Medical Center
Worcester, Massachusetts, 01655

Other trials in United States

About this study

Conditions: Diabetes Mellitus
Being tested: Continuous Glucose Monitoring, Care Coordination
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Continuous Glucose MonitoringDevice
Participants in the experimental arm will receive an unblinded flash continuous glucose monitor.
Care CoordinationOther
All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.

Study groups in NCT05197829
Study group	Role	What they receive
Continuous Glucose Monitoring	Experimental	Not described Receives: Device: Continuous Glucose Monitoring; Other: Care Coordination
Care Coordination	Active comparator	Not described Receives: Other: Care Coordination

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Diabetes Distress
Diabetes-related distress will be measured via the 17-question Diabetes Distress Scale (DDS). A higher score indicates more diabetes-related distress. The scale ranges from 1 (low distress) to 6 (high distress).
Measured: Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks)
Outpatient Clinic Attendance Rate
This outcome will measure whether or not each participant attends a subspecialty follow-up appointment as recommended by the emergency room care team.
Measured: Follow-up visits will generally occur within 2 or 3 weeks
Change in the Problem Areas in Diabetes Score
Each participant will fill out the five-question Problem Areas In Diabetes (PAID5) scale. A higher score indicates worse quality of life. Scores range from 0 (good quality of life) to 20 (poor quality of life).
Measured: Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks)

Secondary outcomes (6)

Number of Patients With Repeat Emergency Utilization
This metric will include repeat emergency room visits and emergency medical services calls.
Measured: 6 months
Change in Hemoglobin A1c
Hemoglobin A1c values drawn as part of routine care will be recorded. A positive value indicates that the hemoglobin A1c was lower at follow up than it was at baseline.
Measured: 6 Months
Outpatient Visits for Which the CGM Data Changed Management
For each patient in the CGM arm, the provider will complete a survey at the time of the initial outpatient follow-up appointment.
Measured: 2-3 Weeks
Time In Range
For participants in the continuous glucose monitoring arm, we will measure the percentage of time spent with a blood sugar level between 70 and 180 mg/dl.
Measured: Up to 14 days after the initial emergency visit
Percentage Time CGM Active
For participants in the continuous glucose monitoring arm, we will measure the amount of time the sensor was worn.
Measured: Up to 14 days after the initial emergency visit
Number of Sensor Checks Per Day
For participants in the continuous glucose monitoring arm, we will measure the number of times per day the sensor was used to check a blood sugar level.
Measured: Up to 14 days after the initial emergency visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jan 20225 Jan 2024

First posted20 Jan 2022
Study start5 Jan 2022
Primary completion5 Jan 2023
Study completion5 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05197829
Sponsor's protocol ID: H00023559
Acronym: GOOD-ER
Status last verified: Mar 2024
First submitted: 13 Dec 2021
Last updated: 16 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: De-identified individual-level data underlying published results will be shared with other researchers at the discretion of the principal investigator in accordance with local and institutional policies.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Glycemic Optimization On Discharge From the Emergency Room
ClinicalTrials.gov ID: NCT05197829
Acronym / sponsor ID: GOOD-ER / H00023559
Conditions: Diabetes Mellitus
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Mark O'ConnorUniversity, hospital or other
Study start: 5 Jan 2022 (actual)
Primary completion: 5 Jan 2023 (actual)
Study completion: 5 Jan 2024 (actual)
First posted: 20 Jan 2022 (actual)
Results: Posted 16 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Continuous Glucose Monitoring	Experimental	Device: Continuous Glucose Monitoring, Other: Care Coordination
Care Coordination	Active comparator	Other: Care Coordination

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Seen in the Emergency Department for hypo- or hyperglycemia
Either an existing diabetes center patient or a new referral
Type 1 or type 2 diabetes
Able to provide informed consent
Fluent in English or Spanish

Key exclusion criteria (7 listed)

Current CGM use
Need for hospital admission
Upcoming CT or MRI within 2 weeks
Pregnancy
Altered mental status

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 MonitoringParticipants in the experimental arm will receive an unblinded flash continuous glucose monitor.	Device	Continuous Glucose Monitoring
Care CoordinationAll participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.	Other	Care Coordination, Continuous Glucose Monitoring

Primary outcome

Change in Diabetes Distress
Time frame: Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks)
Diabetes-related distress will be measured via the 17-question Diabetes Distress Scale (DDS). A higher score indicates more diabetes-related distress. The scale ranges from 1 (low distress) to 6 (high distress).
Outpatient Clinic Attendance Rate
Time frame: Follow-up visits will generally occur within 2 or 3 weeks
This outcome will measure whether or not each participant attends a subspecialty follow-up appointment as recommended by the emergency room care team.
Change in the Problem Areas in Diabetes Score
Time frame: Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks)
Each participant will fill out the five-question Problem Areas In Diabetes (PAID5) scale. A higher score indicates worse quality of life. Scores range from 0 (good quality of life) to 20 (poor quality of life).

6 secondary outcomes

Number of Patients With Repeat Emergency Utilization
Time frame: 6 months
Change in Hemoglobin A1c
Time frame: 6 Months
Outpatient Visits for Which the CGM Data Changed Management
Time frame: 2-3 Weeks
Time In Range
Time frame: Up to 14 days after the initial emergency visit
Percentage Time CGM Active
Time frame: Up to 14 days after the initial emergency visit
Number of Sensor Checks Per Day
Time frame: Up to 14 days after the initial emergency visit

Results and safety

Results posted to the registry on 16 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Continuous Glucose Monitoring	16	16
Care Coordination	14	14

Primary outcome: Change in Diabetes Distress

Time frame: Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks). Mean (Standard Deviation). Unit: units on a scale

Measure	Continuous Glucose Monitoring n = 12	Care Coordination n = 10
Value	0 (1.1)	0.5 (1)

Population analysed: We analyzed data for patients who completed both the intake survey and the follow-up survey. Some participants never completed the follow-up survey.

Primary outcome: Outpatient Clinic Attendance Rate

Time frame: Follow-up visits will generally occur within 2 or 3 weeks. Count of participants. Unit: Participants

Measure	Continuous Glucose Monitoring n = 16	Care Coordination n = 14
Value	12	9

Primary outcome: Change in the Problem Areas in Diabetes Score

Time frame: Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks). Mean (Standard Deviation). Unit: units on a scale

Measure	Continuous Glucose Monitoring n = 12	Care Coordination n = 10
Value	0 (5.8)	2.3 (3.2)

Population analysed: We analyzed data for patients who completed both the intake survey and the follow-up survey. Some participants never completed the follow-up survey.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Continuous Glucose Monitoring	0 of 16 (0%)	0 of 16 (0%)	1 of 16
Care Coordination	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. De-identified individual-level data underlying published results will be shared with other researchers at the discretion of the principal investigator in accordance with local and institutional policies.

Related trials for Diabetes Mellitus

Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
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RecruitingPhase 2
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RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
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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.

Mark J O'Connor, MD principal investigator

University of Massachusetts, Worcester

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 and Care Coordination in people with Diabetes Mellitus, run by Mark O'Connor 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 5 inclusion and 7 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 16 Apr 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 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?

Yes. Results are posted in the registry (first posted 16 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Diabetes Distress (time frame: Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks)). 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?

On the ClinicalTrials.gov record for NCT05197829.

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 Apr 2024.