Trial Outcomes & Findings for Diabetes Remote Care Management System (NCT NCT01354015)
NCT ID: NCT01354015
Last Updated: 2017-05-09
Results Overview
change in A1c from baseline in intervention and control groups
COMPLETED
NA
98 participants
baseline to 6 months
2017-05-09
Participant Flow
01/01/12 from diabetes clinic
Participant milestones
| Measure |
Use of Messaging System
Use of DRMS
DRMS: USE OF TEXT MESSAGING SYSTEM
|
Usual Care
Usual Care
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
48
|
|
Overall Study
COMPLETED
|
44
|
43
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Diabetes Remote Care Management System
Baseline characteristics by cohort
| Measure |
Use of Messaging System
n=50 Participants
Use of DRMS
DRMS: USE OF TEXT MESSAGING SYSTEM
|
Usual Care
n=48 Participants
Usual Care
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.9 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
59.3 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
59.1 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
37 participants
n=5 Participants
|
27 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
13 participants
n=5 Participants
|
17 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 6 monthsPopulation: Of the 50 enrolled in the Use of DRMS group, only 44 completed the visit at 6 months, and out of 48 enrolled in the Usual Care group only 43 completed the visit at 6 months. Therefore only those who completed the visit at 6 months were included in this analysis.
change in A1c from baseline in intervention and control groups
Outcome measures
| Measure |
Use of Messaging System
n=44 Participants
Use of DRMS
DRMS: USE OF TEXT MESSAGING SYSTEM
|
Usual Care
n=43 Participants
Usual Care
|
|---|---|---|
|
Change in HbA1c
|
-0.25 Percent
Standard Deviation 0.2
|
-0.4 Percent
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: baseline to 3 monthsPopulation: Of the 50 enrolled in the Use of DRMS group, only 46 completed the visit at 3 months, and out of 48 enrolled in the Usual Care group only 45 completed the visit at 3 months. Therefore only those who completed the visit at 3 months were included in this analysis.
Change in HbA1c
Outcome measures
| Measure |
Use of Messaging System
n=46 Participants
Use of DRMS
DRMS: USE OF TEXT MESSAGING SYSTEM
|
Usual Care
n=45 Participants
Usual Care
|
|---|---|---|
|
Change in HbA1c Over 3 Months
|
-0.5 Percent
Standard Deviation 0.3
|
-0.2 Percent
Standard Deviation 0.2
|
Adverse Events
Use of Messaging System
Usual Care
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