Type 1 Diabetes Mellitus
Conditions
Keywords
Sensing Technology, Type 1 Diabetes,
Brief summary
The purpose of this study is to evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on hypoglycaemia compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 1 diabetes using insulin.
Interventions
Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time). All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
Sponsors
Abbott Diabetes Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with Type 1 diabetes for ≥ 5 years 2. On their current insulin regimen for ≥ 3 months prior to study entry 3. Screening HbA1c result ≤ 7.5% (58 mmol/mol) 4. Reports self testing of blood glucose levels on a regular basis equivalent to a minimum of 3 times daily for at least 2 months prior to study entry 5. In the investigator's opinion the subject is considered technically capable of using the Abbott Sensor Based Glucose Monitoring System 6. Aged 18 years or over.
Exclusion criteria
1. Subject has been diagnosed with hypoglycaemic unawareness (i.e. subject has a diagnosis of impaired awareness of hypoglycaemia recorded in their medical notes OR in the investigator's opinion the subject currently experiences less than minimal warning symptoms for impending hypoglycaemia) 2. Subject is currently prescribed animal insulin 3. Subject is currently prescribed oral steroid therapy or is likely to require oral steroid therapy for any acute or chronic condition during the study 4. Has known allergy to medical grade adhesives 5. Currently participating in another device or drug study that could affect glucose measurements or glucose management 6. Currently using a Continuous Glucose Monitoring (CGM) device or has used one within the previous 4 months 7. Currently using Sensor augmented pump therapy 8. Is planning to use a CGM device at any time during the study 9. A female subject who is pregnant or planning to become pregnant within the study duration 10. A breast feeding mother 11. Currently receiving dialysis treatment or planning to receive dialysis during the study 12. Has a pacemaker 13. Has experienced an acute myocardial infarction within previous 6 months 14. Has a concomitant disease or condition that may compromise subject safety including; unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any other uncontrolled medical condition 15. Has experienced an episode of confirmed or suspected diabetic ketoacidosis (DKA) in the previous 6 months 16. In the investigator's opinion, the subject is considered unsuitable for inclusion in the study for any other reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Spent <70 mg/dL | Baseline and Days 194 to 208 | Difference in time \<70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Spent <55 mg/dL and <40 mg/dL | Baseline and Days 194 to 208 | Difference in time \<55 mg/dL & \<40 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15). |
| Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL | Baseline and Days 194-208 | Difference in frequency of episodes \<70 mg/dL, \<55 mg/dL and \<40 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15). |
| Time Spent >180 mg/dL and >240 mg/dL | Baseline and Days 194 to 208 | Difference in time \>180 mg/dL and \>240 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15). |
| HbA1c at 6 Months | Baseline and Day 208 | Difference in HbA1c between intervention and control group at day 208 adjusting for baseline HbA1c at day 1 |
| Number of Glucose Measurements Performed | Days 1 to 208 | Number of blood glucose fingerstick tests per day by intervention and control group during baseline (days 1 to 15) and days 194 to 208. The number of sensor scans performed performed by the intervention group during days 15 to 208. |
| System Utilisation | Days 15 to 208 | System utilisation assessed by percentage of sensor glucose data collected by the intervention group |
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208 | Baseline and Day 208 | The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (which ranges from -3 (much less satisfied) to +3 (much more satisfied). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied). There is one question to assess the change in perceived frequency of Hypoglycaemia and one question to assess change in perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less of the time now) to +3 (much more of the time now). The ANCOVA adjusts for baseline DTSQs (status version). |
| Time in Range | Baseline and Days 194 to 208 | Difference in time in range 70-180 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15 time in range). |
Countries
Austria, Germany, Netherlands, Spain, Sweden
Participant flow
Pre-assignment details
A total of 328 subjects consented and enrolled into the study. Eighty-seven (87) of these failed screening or withdrew before randomisation. Two hundred and forty-one (241) subjects were randomised and 211 completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Sensor Based Glucose Monitoring System Standard sensing system use for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time). | 119 |
| Standard Blood Glucose Monitoring Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time). | 120 |
| Total | 239 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Allocated to control group | 0 | 3 |
| Overall Study | Had device-associated symptoms | 7 | 0 |
| Overall Study | Met exclusion criteria | 1 | 1 |
| Overall Study | Non-compliance with study device | 1 | 4 |
| Overall Study | Pregnancy | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 11 |
Baseline characteristics
| Characteristic | Sensor Based Glucose Monitoring System | Standard Blood Glucose Monitoring | Total |
|---|---|---|---|
| Age, Continuous | 42.4 years STANDARD_DEVIATION 13.1 | 45.0 years STANDARD_DEVIATION 14.6 | 43.7 years STANDARD_DEVIATION 13.9 |
| Screening HbA1c | 50.1 mmol/mol STANDARD_DEVIATION 5.7 | 50.2 mmol/mol STANDARD_DEVIATION 6.5 | 6.74 % STANDARD_DEVIATION 0.56 |
| Sex: Female, Male Female | 42 Participants | 61 Participants | 103 Participants |
| Sex: Female, Male Male | 77 Participants | 59 Participants | 136 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 33 / 120 | 24 / 121 |
| serious Total, serious adverse events | 4 / 120 | 4 / 121 |
Outcome results
Primary
Time Spent <70 mg/dL
Difference in time \<70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
Time frame: Baseline and Days 194 to 208
Population: 1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor Based Glucose Monitoring System | Time Spent <70 mg/dL | Baseline | 3.38 hours per day | Standard Deviation 2.31 |
| Sensor Based Glucose Monitoring System | Time Spent <70 mg/dL | Days 194-208 | 2.03 hours per day | Standard Deviation 1.93 |
| Standard Blood Glucose Monitoring | Time Spent <70 mg/dL | Baseline | 3.44 hours per day | Standard Deviation 2.62 |
| Standard Blood Glucose Monitoring | Time Spent <70 mg/dL | Days 194-208 | 3.27 hours per day | Standard Deviation 2.58 |
p-value: <0.0001ANCOVA
Secondary
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208
The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (which ranges from -3 (much less satisfied) to +3 (much more satisfied). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied). There is one question to assess the change in perceived frequency of Hypoglycaemia and one question to assess change in perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less of the time now) to +3 (much more of the time now). The ANCOVA adjusts for baseline DTSQs (status version).
Time frame: Baseline and Day 208
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor Based Glucose Monitoring System | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208 | Hyperglycaemia | -0.6 units on a scale | Standard Deviation 1.6 |
| Sensor Based Glucose Monitoring System | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208 | Hypoglycaemia | -0.3 units on a scale | Standard Deviation 1.6 |
| Sensor Based Glucose Monitoring System | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208 | Treatment Satisfaction | 13.4 units on a scale | Standard Deviation 5.5 |
| Standard Blood Glucose Monitoring | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208 | Hyperglycaemia | 0.5 units on a scale | Standard Deviation 1.2 |
| Standard Blood Glucose Monitoring | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208 | Hypoglycaemia | 0.1 units on a scale | Standard Deviation 1.1 |
| Standard Blood Glucose Monitoring | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208 | Treatment Satisfaction | 7.2 units on a scale | Standard Deviation 6.2 |
Comparison: Statistical analysis of perceived frequency of hyperglycaemiap-value: <0.0001ANCOVA
Comparison: Statistical analysis of perceived frequency of hypoglycaemiap-value: 0.0713ANCOVA
Comparison: Statistical analysis of total treatment satisfaction scorep-value: <0.0001ANCOVA
Secondary
Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL
Difference in frequency of episodes \<70 mg/dL, \<55 mg/dL and \<40 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
Time frame: Baseline and Days 194-208
Population: 1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor Based Glucose Monitoring System | Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL | Frequency of episodes <55 mg/dL, Baseline | 0.96 number of episodes per day | Standard Deviation 0.65 |
| Sensor Based Glucose Monitoring System | Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL | Frequency of episodes <55 mg/dL, Days 194-208 | 0.56 number of episodes per day | Standard Deviation 0.55 |
| Sensor Based Glucose Monitoring System | Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL | Frequency of episodes <40 mg/dL, Baseline | 0.39 number of episodes per day | Standard Deviation 0.43 |
| Sensor Based Glucose Monitoring System | Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL | Frequency of episodes <70 mg/dL, Days 194-208 | 1.32 number of episodes per day | Standard Deviation 0.81 |
| Sensor Based Glucose Monitoring System | Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL | Frequency of episodes <40 mg/dL, Days 194-208 | 0.19 number of episodes per day | Standard Deviation 0.29 |
| Sensor Based Glucose Monitoring System | Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL | Frequency of episodes <70 mg/dL, Baseline | 1.81 number of episodes per day | Standard Deviation 0.9 |
| Standard Blood Glucose Monitoring | Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL | Frequency of episodes <40 mg/dL, Days 194-208 | 0.43 number of episodes per day | Standard Deviation 0.55 |
| Standard Blood Glucose Monitoring | Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL | Frequency of episodes <70 mg/dL, Baseline | 1.67 number of episodes per day | Standard Deviation 0.8 |
| Standard Blood Glucose Monitoring | Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL | Frequency of episodes <70 mg/dL, Days 194-208 | 1.69 number of episodes per day | Standard Deviation 0.83 |
| Standard Blood Glucose Monitoring | Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL | Frequency of episodes <55 mg/dL, Days 194-208 | 0.92 number of episodes per day | Standard Deviation 0.74 |
| Standard Blood Glucose Monitoring | Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL | Frequency of episodes <40 mg/dL, Baseline | 0.44 number of episodes per day | Standard Deviation 0.51 |
| Standard Blood Glucose Monitoring | Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL | Frequency of episodes <55 mg/dL, Baseline | 0.92 number of episodes per day | Standard Deviation 0.73 |
Comparison: Statistical analysis of frequency of episodes \<70 mg/dLp-value: <0.0001ANCOVA
Comparison: Statistical analysis of frequency of episodes \<55 mg/dLp-value: <0.0001ANCOVA
Comparison: Statistical analysis of frequency of episodes \<40 mg/dLp-value: <0.0001ANCOVA
Secondary
HbA1c at 6 Months
Difference in HbA1c between intervention and control group at day 208 adjusting for baseline HbA1c at day 1
Time frame: Baseline and Day 208
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor Based Glucose Monitoring System | HbA1c at 6 Months | Baseline | 6.79 percentage of Glycated Haemoglobin | Standard Deviation 0.52 |
| Sensor Based Glucose Monitoring System | HbA1c at 6 Months | Day 208 | 6.94 percentage of Glycated Haemoglobin | Standard Deviation 0.65 |
| Standard Blood Glucose Monitoring | HbA1c at 6 Months | Baseline | 6.78 percentage of Glycated Haemoglobin | Standard Deviation 0.64 |
| Standard Blood Glucose Monitoring | HbA1c at 6 Months | Day 208 | 6.95 percentage of Glycated Haemoglobin | Standard Deviation 0.66 |
p-value: 0.9556ANCOVA
Secondary
Number of Glucose Measurements Performed
Number of blood glucose fingerstick tests per day by intervention and control group during baseline (days 1 to 15) and days 194 to 208. The number of sensor scans performed performed by the intervention group during days 15 to 208.
Time frame: Days 1 to 208
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor Based Glucose Monitoring System | Number of Glucose Measurements Performed | Number of fingerstick tests, Baseline | 5.5 number of measurements per day | Standard Deviation 2 |
| Sensor Based Glucose Monitoring System | Number of Glucose Measurements Performed | Number of fingerstick tests, Days 194-208 | 0.6 number of measurements per day | Standard Deviation 1 |
| Sensor Based Glucose Monitoring System | Number of Glucose Measurements Performed | Number of sensor scans, Days 15-208 | 15.1 number of measurements per day | Standard Deviation 6.9 |
| Standard Blood Glucose Monitoring | Number of Glucose Measurements Performed | Number of fingerstick tests, Baseline | 5.8 number of measurements per day | Standard Deviation 1.7 |
| Standard Blood Glucose Monitoring | Number of Glucose Measurements Performed | Number of fingerstick tests, Days 194-208 | 5.6 number of measurements per day | Standard Deviation 2.2 |
| Standard Blood Glucose Monitoring | Number of Glucose Measurements Performed | Number of sensor scans, Days 15-208 | NA number of measurements per day | — |
Secondary
System Utilisation
System utilisation assessed by percentage of sensor glucose data collected by the intervention group
Time frame: Days 15 to 208
Population: 112 subjects included in the analysis, 7 were not included due to missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensor Based Glucose Monitoring System | System Utilisation | 92.8 percentage of sensor glucose collected | Standard Deviation 7.3 |
Secondary
Time in Range
Difference in time in range 70-180 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15 time in range).
Time frame: Baseline and Days 194 to 208
Population: 1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor Based Glucose Monitoring System | Time in Range | Baseline | 15.0 hours per day | Standard Deviation 2.5 |
| Sensor Based Glucose Monitoring System | Time in Range | Days 194-208 | 15.8 hours per day | Standard Deviation 2.9 |
| Standard Blood Glucose Monitoring | Time in Range | Baseline | 14.8 hours per day | Standard Deviation 2.8 |
| Standard Blood Glucose Monitoring | Time in Range | Days 194-208 | 14.6 hours per day | Standard Deviation 2.9 |
p-value: 0.0006ANCOVA
Secondary
Time Spent >180 mg/dL and >240 mg/dL
Difference in time \>180 mg/dL and \>240 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
Time frame: Baseline and Days 194 to 208
Population: 1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor Based Glucose Monitoring System | Time Spent >180 mg/dL and >240 mg/dL | Time spent >180 mg/dL, Baseline | 5.62 hours per day | Standard Deviation 2.48 |
| Sensor Based Glucose Monitoring System | Time Spent >180 mg/dL and >240 mg/dL | Time spent >180 mg/dL, Days 194-208 | 6.16 hours per day | Standard Deviation 3.05 |
| Sensor Based Glucose Monitoring System | Time Spent >180 mg/dL and >240 mg/dL | Time spent >240 mg/dL, Baseline | 1.85 hours per day | Standard Deviation 1.44 |
| Sensor Based Glucose Monitoring System | Time Spent >180 mg/dL and >240 mg/dL | Time spent >240 mg/dL, Days 194-208 | 1.67 hours per day | Standard Deviation 1.36 |
| Standard Blood Glucose Monitoring | Time Spent >180 mg/dL and >240 mg/dL | Time spent >240 mg/dL, Days 194-208 | 2.06 hours per day | Standard Deviation 1.61 |
| Standard Blood Glucose Monitoring | Time Spent >180 mg/dL and >240 mg/dL | Time spent >180 mg/dL, Baseline | 5.80 hours per day | Standard Deviation 3.11 |
| Standard Blood Glucose Monitoring | Time Spent >180 mg/dL and >240 mg/dL | Time spent >240 mg/dL, Baseline | 1.91 hours per day | Standard Deviation 1.7 |
| Standard Blood Glucose Monitoring | Time Spent >180 mg/dL and >240 mg/dL | Time spent >180 mg/dL, Days 194-208 | 6.08 hours per day | Standard Deviation 3.2 |
Comparison: Statistical analysis of time spent \>180 mg/dLp-value: 0.5623ANCOVA
Comparison: Statistical analysis for time spent \>240 mg/dLp-value: 0.0247ANCOVA
Secondary
Time Spent <55 mg/dL and <40 mg/dL
Difference in time \<55 mg/dL & \<40 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
Time frame: Baseline and Days 194 to 208
Population: 1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor Based Glucose Monitoring System | Time Spent <55 mg/dL and <40 mg/dL | Time spent <55 mg/dL, Baseline | 1.59 hours per day | Standard Deviation 1.42 |
| Sensor Based Glucose Monitoring System | Time Spent <55 mg/dL and <40 mg/dL | Time spent <55 mg/dL, Days 194-208 | 0.80 hours per day | Standard Deviation 0.96 |
| Sensor Based Glucose Monitoring System | Time Spent <55 mg/dL and <40 mg/dL | Time spent <40 mg/dL, Baseline | 0.59 hours per day | Standard Deviation 0.85 |
| Sensor Based Glucose Monitoring System | Time Spent <55 mg/dL and <40 mg/dL | Time spent <40 mg/dL, Days 194-208 | 0.26 hours per day | Standard Deviation 0.47 |
| Standard Blood Glucose Monitoring | Time Spent <55 mg/dL and <40 mg/dL | Time spent <40 mg/dL, Days 194-208 | 0.73 hours per day | Standard Deviation 1.41 |
| Standard Blood Glucose Monitoring | Time Spent <55 mg/dL and <40 mg/dL | Time spent <55 mg/dL, Baseline | 1.77 hours per day | Standard Deviation 1.86 |
| Standard Blood Glucose Monitoring | Time Spent <55 mg/dL and <40 mg/dL | Time spent <40 mg/dL, Baseline | 0.75 hours per day | Standard Deviation 1.11 |
| Standard Blood Glucose Monitoring | Time Spent <55 mg/dL and <40 mg/dL | Time spent <55 mg/dL, Days 194-208 | 1.65 hours per day | Standard Deviation 1.97 |
p-value: <0.0001ANCOVA
p-value: 0.0003ANCOVA