Trial Outcomes & Findings for Short Messaging Service for Optimizing Hemoglobin A1C Management in Low-Income Diabetics (NCT NCT02049359)
NCT ID: NCT02049359
Last Updated: 2023-07-03
Results Overview
Change in A1C from baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
170 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-07-03
Participant Flow
Participant milestones
| Measure |
Control Group
Care as usual; no bidirectional texting
|
Texting
Bidirectional texting weekly for 12 weeks
Texting: Bidirectional texting once weekly for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
75
|
|
Overall Study
COMPLETED
|
69
|
56
|
|
Overall Study
NOT COMPLETED
|
26
|
19
|
Reasons for withdrawal
| Measure |
Control Group
Care as usual; no bidirectional texting
|
Texting
Bidirectional texting weekly for 12 weeks
Texting: Bidirectional texting once weekly for 12 weeks
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
26
|
19
|
Baseline Characteristics
Short Messaging Service for Optimizing Hemoglobin A1C Management in Low-Income Diabetics
Baseline characteristics by cohort
| Measure |
Control Group
n=69 Participants
Care as usual; no bidirectional texting
|
Texting
n=56 Participants
Bidirectional texting weekly for 12 weeks
Texting: Bidirectional texting once weekly for 12 weeks
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
65 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
52.5 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
51.3 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
50 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
69 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksChange in A1C from baseline
Outcome measures
| Measure |
Control Group
n=69 Participants
Care as usual; no bidirectional texting
|
Texting
n=56 Participants
Bidirectional texting weekly for 12 weeks
Texting: Bidirectional texting once weekly for 12 weeks
|
|---|---|---|
|
Change From Baseline A1C
|
1.1 percentage of A1C decrease
Interval 0.6 to 1.6
|
1.4 percentage of A1C decrease
Interval 0.9 to 1.8
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Change in A1C percentage from baseline by demographic characteristics
Change in A1C from baseline based on age, gender, race, type and duration of diabetes
Outcome measures
| Measure |
Control Group
n=69 Participants
Care as usual; no bidirectional texting
|
Texting
n=56 Participants
Bidirectional texting weekly for 12 weeks
Texting: Bidirectional texting once weekly for 12 weeks
|
|---|---|---|
|
Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes
>65 years
|
0.8 percentage of A1C decrease
Interval 0.33 to 1.9
|
1.2 percentage of A1C decrease
Interval 0.2 to 2.2
|
|
Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes
Age 18-35
|
2.1 percentage of A1C decrease
Interval 0.3 to 4.0
|
1.9 percentage of A1C decrease
Interval 0.5 to 2.0
|
|
Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes
36-55 years
|
1.2 percentage of A1C decrease
Interval 0.5 to 1.8
|
1.4 percentage of A1C decrease
Interval 0.8 to 2.1
|
|
Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes
56-65 years
|
0.5 percentage of A1C decrease
Interval 0.2 to 1.2
|
1.5 percentage of A1C decrease
Interval 0.5 to 2.6
|
|
Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes
African American
|
1.2 percentage of A1C decrease
Interval 0.5 to 1.7
|
1.3 percentage of A1C decrease
Interval 0.7 to 1.8
|
|
Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes
Caucasian
|
1.0 percentage of A1C decrease
Interval 0.2 to 1.7
|
1.4 percentage of A1C decrease
Interval 0.8 to 2.0
|
|
Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes
Hispanic
|
2.0 percentage of A1C decrease
Sample inadequate to describe 95% confidence intervals
|
0.9 percentage of A1C decrease
Sample inadequate to describe 95% confidence intervals
|
|
Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes
Other
|
1.0 percentage of A1C decrease
Sample inadequate to describe 95% confidence intervals
|
3.0 percentage of A1C decrease
Sample inadequate to describe 95% confidence intervals
|
|
Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes
Female
|
0.9 percentage of A1C decrease
Interval 0.3 to 1.4
|
1.3 percentage of A1C decrease
Interval 0.8 to 1.7
|
|
Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes
Male
|
1.4 percentage of A1C decrease
Interval 0.6 to 2.4
|
1.5 percentage of A1C decrease
Interval 0.7 to 2.4
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Texting
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