Trial Outcomes & Findings for Managing Insulin With a Voice AI (NCT NCT05081011)
NCT ID: NCT05081011
Last Updated: 2024-01-02
Results Overview
Number of days between study start date and goal fasting sugar
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
8 weeks
Results posted on
2024-01-02
Participant Flow
Participant milestones
| Measure |
Control
Subjects have their insulin titrated via standard of care for 8 weeks. The Voice Assistant Device is limited to providing a daily reminder to take medication.
|
Voice Assistant Device
Subjects have their insulin titrated by a voice assistant device for 8 weeks. The Voice Assistant Device software algorithm is used to provide daily insulin dose and titration instructions.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
21
|
|
Overall Study
Received Intervention as Randomized
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Managing Insulin With a Voice AI
Baseline characteristics by cohort
| Measure |
Control
n=16 Participants
Subjects have their insulin titrated via standard of care for 8 weeks. The Voice Assistant Device is limited to providing a daily reminder to take medication.
|
Voice Assistant Device
n=16 Participants
Subjects have their insulin titrated by a voice assistant device for 8 weeks. The Voice Assistant Device software algorithm is used to provide daily insulin dose and titration instructions.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
54.1 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
55.1 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants who received intervention as randomized
Number of days between study start date and goal fasting sugar
Outcome measures
| Measure |
Control
n=16 Participants
Subjects have their insulin titrated via standard of care for 8 weeks. The Voice Assistant Device is limited to providing a daily reminder to take medication.
|
Voice Assistant Device
n=16 Participants
Subjects have their insulin titrated by a voice assistant device for 8 weeks. The Voice Assistant Device software algorithm is used to provide daily insulin dose and titration instructions.
|
|---|---|---|
|
Time to Optimal Insulin Dose
|
56 days
Interval 29.5 to 56.0
|
15 days
Interval 6.0 to 27.0
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants who received intervention as randomized
Percentage of adherence to taking insulin based on logs over 8 weeks
Outcome measures
| Measure |
Control
n=16 Participants
Subjects have their insulin titrated via standard of care for 8 weeks. The Voice Assistant Device is limited to providing a daily reminder to take medication.
|
Voice Assistant Device
n=16 Participants
Subjects have their insulin titrated by a voice assistant device for 8 weeks. The Voice Assistant Device software algorithm is used to provide daily insulin dose and titration instructions.
|
|---|---|---|
|
Insulin Medication Adherence
|
50.2 percentage of adherance
Standard Deviation 43.0
|
82.9 percentage of adherance
Standard Deviation 20.6
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksPopulation: Participants who received intervention as randomized
Change in Composite Score of Attitudes Toward Diabetes (PAID-5). A 5-item psychometrically validated self-report questionnaire on a 5 point Likert scale (0= not problem; 4= a serious problem). The scores of each item are summed to create an overall score (Minimum value = 0; Maximum value = 20). Higher scores denote higher levels of diabetes related distress.
Outcome measures
| Measure |
Control
n=16 Participants
Subjects have their insulin titrated via standard of care for 8 weeks. The Voice Assistant Device is limited to providing a daily reminder to take medication.
|
Voice Assistant Device
n=16 Participants
Subjects have their insulin titrated by a voice assistant device for 8 weeks. The Voice Assistant Device software algorithm is used to provide daily insulin dose and titration instructions.
|
|---|---|---|
|
Attitudes Toward Diabetes
Baseline
|
6.5 score on a scale
Standard Deviation 4.9
|
8.4 score on a scale
Standard Deviation 3.4
|
|
Attitudes Toward Diabetes
Change at Week 8
|
1.7 score on a scale
Standard Deviation 4.4
|
-1.9 score on a scale
Standard Deviation 4.2
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksPopulation: Participants who received intervention as randomized
Change in Composite Score of Attitudes Toward Health Technology. A 2-item self-report questionnaire on a 5 point Likert scale, scored 0 to 4. The scores are summed to create an overall score (Minimum value = 0, Maximum value = 8). Higher scores indicated more favorable attitudes toward health technology.
Outcome measures
| Measure |
Control
n=16 Participants
Subjects have their insulin titrated via standard of care for 8 weeks. The Voice Assistant Device is limited to providing a daily reminder to take medication.
|
Voice Assistant Device
n=16 Participants
Subjects have their insulin titrated by a voice assistant device for 8 weeks. The Voice Assistant Device software algorithm is used to provide daily insulin dose and titration instructions.
|
|---|---|---|
|
Attitudes Toward Health Technology
Baseline
|
6.6 score on a scale
Standard Deviation 1.9
|
7.1 score on a scale
Standard Deviation 1.5
|
|
Attitudes Toward Health Technology
Change at Week 8
|
-1.1 score on a scale
Standard Deviation 2.3
|
0.3 score on a scale
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksPopulation: Participants who received intervention as randomized
Change in Composite Score of Attitudes Toward Medication Adherence. A 5-item self-report questionnaire on a 5-point Likert scale (0 to 4). The scores are summed to create an overall score (Minimum value = 0, Maximum value = 20). Higher scores indicate more favorable attitudes toward medication adherence.
Outcome measures
| Measure |
Control
n=16 Participants
Subjects have their insulin titrated via standard of care for 8 weeks. The Voice Assistant Device is limited to providing a daily reminder to take medication.
|
Voice Assistant Device
n=16 Participants
Subjects have their insulin titrated by a voice assistant device for 8 weeks. The Voice Assistant Device software algorithm is used to provide daily insulin dose and titration instructions.
|
|---|---|---|
|
Attitudes Toward Medication Adherence
Baseline
|
13.6 score on a scale
Standard Deviation 3.8
|
14.0 score on a scale
Standard Deviation 4.4
|
|
Attitudes Toward Medication Adherence
Change at Week 8
|
-0.1 score on a scale
Standard Deviation 2.6
|
0.8 score on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Participants who received intervention as randomized
Proportion (percentage) of participants with fasting sugar within goal at end of trial.
Outcome measures
| Measure |
Control
n=16 Participants
Subjects have their insulin titrated via standard of care for 8 weeks. The Voice Assistant Device is limited to providing a daily reminder to take medication.
|
Voice Assistant Device
n=16 Participants
Subjects have their insulin titrated by a voice assistant device for 8 weeks. The Voice Assistant Device software algorithm is used to provide daily insulin dose and titration instructions.
|
|---|---|---|
|
Percentage of Participants Who Achieved Glycemic Control
|
25.0 percentage of participants
Interval 8.3 to 52.6
|
81.3 percentage of participants
Interval 53.7 to 95.0
|
SECONDARY outcome
Timeframe: Day 3 and 8 weeks (assessed at the end of each 3 day period)Population: Participants who received intervention as randomized
Change in 3-day average fasting sugars between first 3 days and last 3 days of study
Outcome measures
| Measure |
Control
n=16 Participants
Subjects have their insulin titrated via standard of care for 8 weeks. The Voice Assistant Device is limited to providing a daily reminder to take medication.
|
Voice Assistant Device
n=16 Participants
Subjects have their insulin titrated by a voice assistant device for 8 weeks. The Voice Assistant Device software algorithm is used to provide daily insulin dose and titration instructions.
|
|---|---|---|
|
Glycemic Improvement
Baseline
|
145.9 mg/dL
Standard Deviation 41.5
|
167.5 mg/dL
Standard Deviation 53.9
|
|
Glycemic Improvement
Change at Week 8
|
23.0 mg/dL
Standard Deviation 54.7
|
-45.9 mg/dL
Standard Deviation 45.9
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Voice Assistant Device
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