Trial Outcomes & Findings for Impact of a Virtual Diabetes Self-Care and Education Program on Diabetes-related Outcomes in Latinos With T2 Diabetes (NCT NCT02488785)
NCT ID: NCT02488785
Last Updated: 2022-09-06
Results Overview
The A1C test is a blood test used to diagnose type 2 diabetes and then to manage diabetes. It is measured as a percent.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
96 participants
Primary outcome timeframe
9 months
Results posted on
2022-09-06
Participant Flow
Participant milestones
| Measure |
Control
Patients in this group will attend regular clinical and education appointments as offered by the clinic for their diabetes care.
|
Intervention
Patients in this group will be part of a Virtual Diabetes Self-Care and Education (DSME) Program. They will receive a phone to communicate with a diabetes educator (DE) for 6 months. They will connect with the DE for weekly video conferences of up to 30 minutes for twelve consecutive weeks, followed by 7 phone calls. They will receive a weekly text message about diabetes for 6 months.
Virtual (DSME) Program: Participants will have frequent contact in order to share physical activity and glucose data with the DE using the smartphone they will receive. Information downloaded to the Glooko Population Management tool can be shared with the DE.
Fitbit: Participants will be given a Fitbit physical activity tracker which they can use to record their activity and share the information with the diabetes educator using the device's smartphone application.
Smartphone: All virtual visits were performed via provided smartphone. Participants will receive a Glooko MeterSyn
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
49
|
|
Overall Study
COMPLETED
|
41
|
38
|
|
Overall Study
NOT COMPLETED
|
6
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of a Virtual Diabetes Self-Care and Education Program on Diabetes-related Outcomes in Latinos With T2 Diabetes
Baseline characteristics by cohort
| Measure |
Control
n=47 Participants
Patients in this group will attend regular clinical and education appointments as offered by the clinic for their diabetes care.
|
Intervention
n=49 Participants
Patients (pt) in this group will be part of a Virtual Diabetes Self-Care and Education (DSME) Program. Pt will receive a phone to connect with a diabetes educator (DE) for 6 months. Pt will have a weekly video call of up to 30 min. with the DE for 12 weeks, followed by 7 phone calls. Pt will get a weekly text message about diabetes for 6 months.
Virtual DSME Program: pt will have frequent contact in order to share physical activity and glucose data with the DE using smartphone. Information downloaded to the Glooko can be shared with the DE.
Fitbit: Participants will be given a Fitbit physical activity tracker which they can use to record their activity and share the information with the DE using the device's smartphone application.
Smartphone: All virtual visits were performed via. In addition, pt will receive a Glooko MeterSync which is able to connect to most glucose meters in order to download glucose data to the Glooko Population Management tool on their smartphones
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
50.9 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
54.2 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
47 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
|
Region of Enrollment
United States
|
47 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Hemoglobin A1C
|
9.56 %
STANDARD_DEVIATION 1.3 • n=5 Participants
|
9.97 %
STANDARD_DEVIATION 1.78 • n=7 Participants
|
9.7 %
STANDARD_DEVIATION 1.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 9 monthsThe A1C test is a blood test used to diagnose type 2 diabetes and then to manage diabetes. It is measured as a percent.
Outcome measures
| Measure |
Control
n=39 Participants
Patients in this group will attend regular clinical and education appointments as offered by the clinic for their diabetes care.
|
Intervention
n=36 Participants
Patients in this group will be part of a Virtual Diabetes Self-Care and Education (DSME) Program. They will receive a phone to communicate with a diabetes educator (DE) for 6 months. They will connect with the DE for weekly video conferences of up to 30 minutes for twelve consecutive weeks, followed by 7 phone calls. They will receive a weekly text message about diabetes for 6 months.
Virtual (DSME) Program: Participants will have frequent contact in order to share physical activity and glucose data with the DE using the smartphone they will receive. Information downloaded to the Glooko Population Management tool can be shared with the DE.
Fitbit: Participants will be given a Fitbit physical activity tracker which they can use to record their activity and share the information with the diabetes educator using the device's smartphone application.
Smartphone: All virtual visits were performed via provided smartphone. Participants will receive a Glooko MeterSyn
|
|---|---|---|
|
Hemoglobin A1c
|
8.41 percentage of A1C
Standard Deviation 1.55
|
8.18 percentage of A1C
Standard Deviation 1.59
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place