Trial Outcomes & Findings for Glycemic Optimization On Discharge From the Emergency Room (NCT NCT05197829)

NCT ID: NCT05197829

Last Updated: 2024-04-16

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks)

Results posted on

2024-04-16

Participant Flow

Participant milestones

Participant milestones
Measure	Continuous Glucose Monitoring Continuous Glucose Monitoring: Participants in the experimental arm will receive an unblinded flash continuous glucose monitor. Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.	Care Coordination Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.
Overall Study STARTED	16	14
Overall Study COMPLETED	16	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Glycemic Optimization On Discharge From the Emergency Room

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continuous Glucose Monitoring n=16 Participants Continuous Glucose Monitoring: Participants in the experimental arm will receive an unblinded flash continuous glucose monitor. Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.	Care Coordination n=14 Participants Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.	Total n=30 Participants Total of all reporting groups
Age, Continuous	56 years n=5 Participants	60 years n=7 Participants	58 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	14 participants n=7 Participants	30 participants n=5 Participants
Type 2 Diabetes	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
New Diagnosis	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Baseline A1c	11.5 percentage of glycated hemoglobin STANDARD_DEVIATION 2.6 • n=5 Participants	10.6 percentage of glycated hemoglobin STANDARD_DEVIATION 3 • n=7 Participants	11.1 percentage of glycated hemoglobin STANDARD_DEVIATION 2.8 • n=5 Participants

PRIMARY outcome

Timeframe: Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks)

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

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitoring n=12 Participants Continuous Glucose Monitoring: Participants in the experimental arm will receive an unblinded flash continuous glucose monitor. Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.	Care Coordination n=10 Participants Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.
Change in Diabetes Distress	0 units on a scale Standard Deviation 1.1	0.5 units on a scale Standard Deviation 1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitoring n=16 Participants Continuous Glucose Monitoring: Participants in the experimental arm will receive an unblinded flash continuous glucose monitor. Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.	Care Coordination n=14 Participants Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.
Outpatient Clinic Attendance Rate	12 Participants	9 Participants

PRIMARY outcome

Timeframe: Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks)

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

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).

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitoring n=12 Participants Continuous Glucose Monitoring: Participants in the experimental arm will receive an unblinded flash continuous glucose monitor. Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.	Care Coordination n=10 Participants Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.
Change in the Problem Areas in Diabetes Score	0 units on a scale Standard Deviation 5.8	2.3 units on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: 6 months

This metric will include repeat emergency room visits and emergency medical services calls.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitoring n=16 Participants Continuous Glucose Monitoring: Participants in the experimental arm will receive an unblinded flash continuous glucose monitor. Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.	Care Coordination n=14 Participants Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.
Number of Patients With Repeat Emergency Utilization	5 Participants	7 Participants

SECONDARY outcome

Timeframe: 6 Months

Population: We analyzed data for participants who had both a baseline A1c and a follow-up A1c, regardless of whether they attended clinic follow-up visits or not. Some participants did not have follow-up A1c values and were not included in this analysis.

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.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitoring n=10 Participants Continuous Glucose Monitoring: Participants in the experimental arm will receive an unblinded flash continuous glucose monitor. Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.	Care Coordination n=10 Participants Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.
Change in Hemoglobin A1c	5.2 percentage of glycated hemoglobin Standard Deviation 3.3	2.4 percentage of glycated hemoglobin Standard Deviation 3.4

SECONDARY outcome

Timeframe: 2-3 Weeks

Population: We analyzed data for all provider surveys received.

For each patient in the CGM arm, the provider will complete a survey at the time of the initial outpatient follow-up appointment.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitoring n=10 Participants Continuous Glucose Monitoring: Participants in the experimental arm will receive an unblinded flash continuous glucose monitor. Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.	Care Coordination Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.
Outpatient Visits for Which the CGM Data Changed Management	7 Participants	—

SECONDARY outcome

Timeframe: Up to 14 days after the initial emergency visit

Population: We analyzed data for all participants who wore the CGM and returned to clinic with data.

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.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitoring n=9 Participants Continuous Glucose Monitoring: Participants in the experimental arm will receive an unblinded flash continuous glucose monitor. Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.	Care Coordination Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.
Time In Range	37 Percentage of time Interval 0.0 to 95.0	—

SECONDARY outcome

Timeframe: Up to 14 days after the initial emergency visit

Population: We analyzed data for all participants who wore the CGM and returned to clinic with data.

For participants in the continuous glucose monitoring arm, we will measure the amount of time the sensor was worn.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitoring n=9 Participants Continuous Glucose Monitoring: Participants in the experimental arm will receive an unblinded flash continuous glucose monitor. Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.	Care Coordination Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.
Percentage Time CGM Active	73 Percentage of time Interval 24.0 to 100.0	—

SECONDARY outcome

Timeframe: Up to 14 days after the initial emergency visit

Population: We analyzed data for all participants who wore the CGM and returned to clinic with data.

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.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitoring n=9 Participants Continuous Glucose Monitoring: Participants in the experimental arm will receive an unblinded flash continuous glucose monitor. Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.	Care Coordination Care Coordination: All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.
Number of Sensor Checks Per Day	15 Scans per day Interval 1.0 to 36.0	—

Adverse Events

Continuous Glucose Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Care Coordination

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark O'Connor

University of Massachusetts Chan Medical School

Phone: 508-334-1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place