Trial Outcomes & Findings for Virtual Diabetes Specialty Clinic: A Study Evaluating Remote Initiation of Continuous Glucose Monitoring (NCT NCT04765358)
NCT ID: NCT04765358
Last Updated: 2024-04-16
Results Overview
Percentage of red blood cells with glucose coated hemoglobin
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
235 participants
Primary outcome timeframe
26 weeks
Results posted on
2024-04-16
Participant Flow
Participant milestones
| Measure |
All Participants
All participants were provided with a commercially available CGM system. Training and data collection for the study was completed remotely. After initial CGM training (initiation of unblinded CGM use or initial training with virtual clinic) was completed, participants were followed by the virtual clinic team for approximately six months. Psychosocial screening questionnaires were administered at enrollment and during follow up. The virtual clinical team member followed up with the study participant if there was an elevated score on the psychosocial screening questionnaires. After the initial six months of follow up, participants who decided to continue to use CGM were asked to extend follow up and complete questionnaires, submit HbA1c samples, and share data. During the extended follow up phase, participants were able to contact the virtual clinic with questions or to request assistance as needed.
Virtual Clinic: CGM, Clinical Care Support and Behavioral Health Support
|
|---|---|
|
Overall Study
STARTED
|
235
|
|
Overall Study
COMPLETED
|
234
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
All Participants
All participants were provided with a commercially available CGM system. Training and data collection for the study was completed remotely. After initial CGM training (initiation of unblinded CGM use or initial training with virtual clinic) was completed, participants were followed by the virtual clinic team for approximately six months. Psychosocial screening questionnaires were administered at enrollment and during follow up. The virtual clinical team member followed up with the study participant if there was an elevated score on the psychosocial screening questionnaires. After the initial six months of follow up, participants who decided to continue to use CGM were asked to extend follow up and complete questionnaires, submit HbA1c samples, and share data. During the extended follow up phase, participants were able to contact the virtual clinic with questions or to request assistance as needed.
Virtual Clinic: CGM, Clinical Care Support and Behavioral Health Support
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Virtual Diabetes Specialty Clinic: A Study Evaluating Remote Initiation of Continuous Glucose Monitoring
Baseline characteristics by cohort
| Measure |
All Participants
n=234 Participants
All participants were provided with a commercially available CGM system. Training and data collection for the study was completed remotely. After initial CGM training (initiation of unblinded CGM use or initial training with virtual clinic) was completed, participants were followed by the virtual clinic team for approximately six months. Psychosocial screening questionnaires were administered at enrollment and during follow up. The virtual clinical team member followed up with the study participant if there was an elevated score on the psychosocial screening questionnaires. After the initial six months of follow up, participants who decided to continue to use CGM were asked to extend follow up and complete questionnaires, submit HbA1c samples, and share data. During the extended follow up phase, participants were able to contact the virtual clinic with questions or to request assistance as needed.
Virtual Clinic: CGM, Clinical Care Support and Behavioral Health Support
|
|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 14 • n=99 Participants
|
|
Sex: Female, Male
Female
|
123 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
187 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
African American
|
20 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
American Indian-Alaskan Native
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Do not wish to answer
|
7 Participants
n=99 Participants
|
|
Hemoglobin A1c
|
63 mmol/mol
STANDARD_DEVIATION 17.5 • n=99 Participants
|
|
Time Spent with Glucose 70-<180 mg/dL
|
49 percentage of 24 hour period
STANDARD_DEVIATION 25 • n=99 Participants
|
PRIMARY outcome
Timeframe: 26 weeksPercentage of red blood cells with glucose coated hemoglobin
Outcome measures
| Measure |
All Participants
n=226 Participants
All participants were provided with a commercially available CGM system. Training and data collection for the study was completed remotely. After initial CGM training (initiation of unblinded CGM use or initial training with virtual clinic) was completed, participants were followed by the virtual clinic team for approximately six months. Psychosocial screening questionnaires were administered at enrollment and during follow up. The virtual clinical team member followed up with the study participant if there was an elevated score on the psychosocial screening questionnaires. After the initial six months of follow up, participants who decided to continue to use CGM were asked to extend follow up and complete questionnaires, submit HbA1c samples, and share data. During the extended follow up phase, participants were able to contact the virtual clinic with questions or to request assistance as needed.
Virtual Clinic: CGM, Clinical Care Support and Behavioral Health Support
|
|---|---|
|
Hemoglobin A1C (HbA1c)
|
54 mmol/mol
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: 26 weeksPercentage of 24 hour period with blood glucose in target range of 70-180 mg/dL
Outcome measures
| Measure |
All Participants
n=234 Participants
All participants were provided with a commercially available CGM system. Training and data collection for the study was completed remotely. After initial CGM training (initiation of unblinded CGM use or initial training with virtual clinic) was completed, participants were followed by the virtual clinic team for approximately six months. Psychosocial screening questionnaires were administered at enrollment and during follow up. The virtual clinical team member followed up with the study participant if there was an elevated score on the psychosocial screening questionnaires. After the initial six months of follow up, participants who decided to continue to use CGM were asked to extend follow up and complete questionnaires, submit HbA1c samples, and share data. During the extended follow up phase, participants were able to contact the virtual clinic with questions or to request assistance as needed.
Virtual Clinic: CGM, Clinical Care Support and Behavioral Health Support
|
|---|---|
|
Time Spent With Glucose 70-180 mg/dL
|
63 percentage of 24 hour period
Standard Deviation 18
|
Adverse Events
All Participants
Serious events: 16 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Participants
n=234 participants at risk
All participants were provided with a commercially available CGM system. Training and data collection for the study was completed remotely. After initial CGM training (initiation of unblinded CGM use or initial training with virtual clinic) was completed, participants were followed by the virtual clinic team for approximately six months. Psychosocial screening questionnaires were administered at enrollment and during follow up. The virtual clinical team member followed up with the study participant if there was an elevated score on the psychosocial screening questionnaires. After the initial six months of follow up, participants who decided to continue to use CGM were asked to extend follow up and complete questionnaires, submit HbA1c samples, and share data. During the extended follow up phase, participants were able to contact the virtual clinic with questions or to request assistance as needed.
Virtual Clinic: CGM, Clinical Care Support and Behavioral Health Support
|
|---|---|
|
Endocrine disorders
Severe hypoglycemia
|
6.8%
16/234 • Number of events 17 • 26 Weeks
|
Other adverse events
| Measure |
All Participants
n=234 participants at risk
All participants were provided with a commercially available CGM system. Training and data collection for the study was completed remotely. After initial CGM training (initiation of unblinded CGM use or initial training with virtual clinic) was completed, participants were followed by the virtual clinic team for approximately six months. Psychosocial screening questionnaires were administered at enrollment and during follow up. The virtual clinical team member followed up with the study participant if there was an elevated score on the psychosocial screening questionnaires. After the initial six months of follow up, participants who decided to continue to use CGM were asked to extend follow up and complete questionnaires, submit HbA1c samples, and share data. During the extended follow up phase, participants were able to contact the virtual clinic with questions or to request assistance as needed.
Virtual Clinic: CGM, Clinical Care Support and Behavioral Health Support
|
|---|---|
|
General disorders
Hospitalization
|
9.4%
22/234 • Number of events 32 • 26 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place