Trial Outcomes & Findings for Study to Understand Gaining Access to Blood Glucose Records (NCT NCT02956642)
NCT ID: NCT02956642
Last Updated: 2025-04-30
Results Overview
Three HbA1c measures per study participant will be acquired at 3 points in the study duration (baseline, 3 months, and 6 months). In order to compare the changes in HbA1c, the values may be analyzed and separated with regard to duration of diabetes (days, months, years), and/or HbA1c levels at baseline. Reported in this table are the means for all participants for each given timepoint.
COMPLETED
NA
84 participants
6 months
2025-04-30
Participant Flow
Participant milestones
| Measure |
Blood Glucose Monitoring System
Participants in this arm will receive the Livongo Health System to manage diabetes. 150 participants will participate in this arm.
Livongo Health System: Participants will be asked to use the Livongo Health System to manage their blood glucose.
|
Standard Blood Glucose Monitoring
Participants in this arm will receive the iHealth Glucose Meter to take blood glucose measurements that will then be compared to participants from the Livongo Health System arm. 150 participants will participate in this arm.
iHealth Glucose Meter: Participants will be asked to use the iHealth Glucose Meter to take blood glucose measurements.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
41
|
|
Overall Study
COMPLETED
|
42
|
38
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Understand Gaining Access to Blood Glucose Records
Baseline characteristics by cohort
| Measure |
Blood Glucose Monitoring System
n=43 Participants
Participants in this arm will receive the Livongo Health System to manage diabetes. 150 participants will participate in this arm.
Livongo Health System: Participants will be asked to use the Livongo Health System to manage their blood glucose.
|
Standard Blood Glucose Monitoring
n=41 Participants
Participants in this arm will receive the iHealth Glucose Meter to take blood glucose measurements that will then be compared to participants from the Livongo Health System arm. 150 participants will participate in this arm.
iHealth Glucose Meter: Participants will be asked to use the iHealth Glucose Meter to take blood glucose measurements.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.3 Years
STANDARD_DEVIATION 11.6 • n=99 Participants
|
60.5 Years
STANDARD_DEVIATION 10.8 • n=107 Participants
|
58.4 Years
STANDARD_DEVIATION 11.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian (including South Asian and Asian Indian)
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
non-Hispanic White
|
35 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
43 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Of all study participants, 4 withdrew from the study (1 in the blood glucose monitoring system group, and 3 in the standard blood glucose monitoring group). The rest of the participants did not complete the lab draw activities and were lost to follow-up.
Three HbA1c measures per study participant will be acquired at 3 points in the study duration (baseline, 3 months, and 6 months). In order to compare the changes in HbA1c, the values may be analyzed and separated with regard to duration of diabetes (days, months, years), and/or HbA1c levels at baseline. Reported in this table are the means for all participants for each given timepoint.
Outcome measures
| Measure |
Blood Glucose Monitoring System
n=43 Participants
Participants in this arm will receive the Livongo Health System to manage diabetes.
Livongo Health System: Participants will be asked to use the Livongo Health System to manage their blood glucose.
|
Standard Blood Glucose Monitoring
n=41 Participants
Participants in this arm will receive the iHealth Glucose Meter to take blood glucose measurements that will then be compared to participants from the Livongo Health System arm.
iHealth Glucose Meter: Participants will be asked to use the iHealth Glucose Meter to take blood glucose measurements.
|
|---|---|---|
|
Mean HbA1c Levels
Baseline
|
8.0 percentage of glycated hemoglobin
Standard Deviation 1.5
|
7.3 percentage of glycated hemoglobin
Standard Deviation 1.1
|
|
Mean HbA1c Levels
3 months
|
7.9 percentage of glycated hemoglobin
Standard Deviation 1.5
|
7.6 percentage of glycated hemoglobin
Standard Deviation 1.2
|
|
Mean HbA1c Levels
6 months
|
7.9 percentage of glycated hemoglobin
Standard Deviation 1.1
|
7.5 percentage of glycated hemoglobin
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: This analysis included participants with data at baseline and at 6 months.
In this analysis, change in HbA1c within individual participants was compared from baseline to 6 months. Only participants with 6-month data were included.
Outcome measures
| Measure |
Blood Glucose Monitoring System
n=20 Participants
Participants in this arm will receive the Livongo Health System to manage diabetes.
Livongo Health System: Participants will be asked to use the Livongo Health System to manage their blood glucose.
|
Standard Blood Glucose Monitoring
n=24 Participants
Participants in this arm will receive the iHealth Glucose Meter to take blood glucose measurements that will then be compared to participants from the Livongo Health System arm.
iHealth Glucose Meter: Participants will be asked to use the iHealth Glucose Meter to take blood glucose measurements.
|
|---|---|---|
|
Change in HbA1c
|
0.31 percentage of glycated hemoglobin
Standard Deviation 0.79
|
0.38 percentage of glycated hemoglobin
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Of all study participants, 4 withdrew from the study (1 in the blood glucose monitoring system group, and 3 in the standard blood glucose monitoring group). The rest of the participants did not complete the lab draw activities and were lost to follow-up.
As a secondary outcome, we will determine the effect of use of the Livongo Health system on fasting lipid panels (LDL). A lipid panel will be done at baseline, 3 months, and at 6 months. Reported in this table are means for all participants with data at each timepoint.
Outcome measures
| Measure |
Blood Glucose Monitoring System
n=43 Participants
Participants in this arm will receive the Livongo Health System to manage diabetes.
Livongo Health System: Participants will be asked to use the Livongo Health System to manage their blood glucose.
|
Standard Blood Glucose Monitoring
n=41 Participants
Participants in this arm will receive the iHealth Glucose Meter to take blood glucose measurements that will then be compared to participants from the Livongo Health System arm.
iHealth Glucose Meter: Participants will be asked to use the iHealth Glucose Meter to take blood glucose measurements.
|
|---|---|---|
|
Mean Fasting LDL
3 months
|
73.9 mg/dL
Standard Deviation 32
|
98.2 mg/dL
Standard Deviation 51.7
|
|
Mean Fasting LDL
6 months
|
87.9 mg/dL
Standard Deviation 32.9
|
92.7 mg/dL
Standard Deviation 48.8
|
|
Mean Fasting LDL
Baseline
|
81 mg/dL
Standard Deviation 33.5
|
94.5 mg/dL
Standard Deviation 26.7
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This analysis included participants with data at baseline and at 6 months.
In this analysis, change in fasting LDL within individual participants was compared from baseline to 6 months. Only participants with 6-month data were included.
Outcome measures
| Measure |
Blood Glucose Monitoring System
n=20 Participants
Participants in this arm will receive the Livongo Health System to manage diabetes.
Livongo Health System: Participants will be asked to use the Livongo Health System to manage their blood glucose.
|
Standard Blood Glucose Monitoring
n=24 Participants
Participants in this arm will receive the iHealth Glucose Meter to take blood glucose measurements that will then be compared to participants from the Livongo Health System arm.
iHealth Glucose Meter: Participants will be asked to use the iHealth Glucose Meter to take blood glucose measurements.
|
|---|---|---|
|
Change in Fasting LDL
|
-0.3 mg/dL
Standard Deviation 24.7
|
-25.25 mg/dL
Standard Deviation 35.7
|
Adverse Events
Blood Glucose Monitoring System
Standard Blood Glucose Monitoring
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