Type 2 Diabetes Mellitus
Conditions
Keywords
Sensing Technology, Type 2 Diabetes,
Brief summary
To evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on glycaemic control (HbA1c) compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 2 diabetes using insulin.
Interventions
Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
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 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
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. Has Type 2 diabetes on insulin therapy for ≥ 6 months and on their current regimen for ≥3 months prior to study entry. 2. Their insulin management must be one of the following; 1. an injection regimen of prandial insulin at least once daily, 2. or, prandial insulin at least once daily plus basal insulin at least once daily, 3. or, continuous subcutaneous insulin infusion (CSII) with no plans to change during the study. 3. HbA1c result ≥7.5% (58 mmol/mol) and ≤12.0% (108 mmol/mol) on entry to the study. 4. Reports self-testing of blood glucose levels on a regular basis equivalent to a minimum of 10 tests per week, 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. In the Investigator's opinion the subject is proactive and therefore willing to modify their diabetes management 7. Aged 18 years or over.
Exclusion criteria
1. Insulin regimen consists entirely of basal or includes bi-phasic insulin. 2. Subject is currently prescribed animal insulin. 3. Subject is currently prescribed steroid therapy or is likely to require 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. Is planning to use a CGM device at any time during the study. 8. Total daily dose of insulin (TDD) is \>1.75iu/kg at entry to the study. 9. A female subject who is pregnant or planning to become pregnant within the study duration. 10. Currently receiving dialysis treatment or planning to receive dialysis during the study. 11. Has experienced an acute myocardial infarction within previous 6 months. 12. Has a concomitant disease or condition that may compromise patient safety, including unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any other uncontrolled medical condition. 13. Has a pacemaker or any other neuro stimulators. 14. Has experienced any episode of severe hypoglycaemia, requiring third party assistance and/or admission to hospital, in the previous 6 months. 15. Has experienced any episode of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycaemic state (HHS) in the previous 6 months. 16. In the investigator's opinion, the subject is considered as unsuitable for inclusion in the study for any other reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c at 6 Months | Baseline and Day 194 | Difference in HbA1c between intervention and control group at day 194 adjusting for baseline HbA1c at day 1 using ANCOVA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Spent <70 mg/dL and <55 mg/dL | Baseline and Days 194 to 208 | Difference in time \<70 mg/dL and \<55 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA. |
| Frequency of Episodes <70 mg/dL and <55 mg/dL | Baseline and Days 194 to 208 | Difference in frequency of episodes \<70 mg/dL and \<55 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA. |
| Time Spent >180 mg/dL and >240 mg/dL | Baseline and Days 194 to 208 | Difference in time \>180 mg/dL and \>240mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA. |
| 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) using ANCOVA. |
| System Utilisation | Days 15 to 208 | Sensor 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 194. | Baseline and Day 194 | 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). |
| Number of Glucose Measurements Performed | Days 15 to 208 | Number of blood glucose fingerstick tests per day by intervention and control group during days 15 to 208. The number of sensor scans performed by the intervention group during days 15 to 208. |
Countries
France, Germany, United Kingdom
Participant flow
Pre-assignment details
A total of 302 subjects consented and enrolled into the study. Seventy-eight (78) of these failed screening or withdrew before randomisation. Two hundred and twenty-four (224) subjects were randomised and 201 completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Sensor Based Glucose Monitoring System Standard system use for 6 months. Followed by open access to the device 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. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation. | 149 |
| 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 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation. | 75 |
| Total | 224 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Device associated symptoms | 5 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Medical diagnosis | 1 | 2 |
| Overall Study | Protocol Violation | 0 | 6 |
| Overall Study | Subject non-compliance | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Sensor Based Glucose Monitoring System | Standard Blood Glucose Monitoring | Total |
|---|---|---|---|
| Age, Continuous | 59.0 years STANDARD_DEVIATION 9.9 | 59.5 years STANDARD_DEVIATION 11 | 59.2 years STANDARD_DEVIATION 10.3 |
| Screening HbA1c | 72.0 mmol/mol STANDARD_DEVIATION 10.6 | 73.5 mmol/mol STANDARD_DEVIATION 11.3 | 8.79 % STANDARD_DEVIATION 0.99 |
| Sex: Female, Male Female | 55 Participants | 19 Participants | 74 Participants |
| Sex: Female, Male Male | 94 Participants | 56 Participants | 150 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 49 / 149 | 27 / 75 |
| serious Total, serious adverse events | 16 / 149 | 12 / 75 |
Outcome results
Primary
HbA1c at 6 Months
Difference in HbA1c between intervention and control group at day 194 adjusting for baseline HbA1c at day 1 using ANCOVA.
Time frame: Baseline and Day 194
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor Based Glucose Monitoring System | HbA1c at 6 Months | Baseline | 8.65 percentage of Glycated Haemoglobin | Standard Deviation 1.01 |
| Sensor Based Glucose Monitoring System | HbA1c at 6 Months | Day 194 | 8.37 percentage of Glycated Haemoglobin | Standard Deviation 0.83 |
| Standard Blood Glucose Monitoring | HbA1c at 6 Months | Baseline | 8.75 percentage of Glycated Haemoglobin | Standard Deviation 0.98 |
| Standard Blood Glucose Monitoring | HbA1c at 6 Months | Day 194 | 8.34 percentage of Glycated Haemoglobin | Standard Deviation 1.14 |
p-value: 0.8222ANCOVA
Secondary
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 194.
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 194
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor Based Glucose Monitoring System | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 194. | Hypoglycaemia | -0.2 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 194. | Hyperglycaemia | 0.3 units on a scale | Standard Deviation 1.9 |
| Sensor Based Glucose Monitoring System | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 194. | Treatment Satisfaction | 13.4 units on a scale | Standard Deviation 4.3 |
| Standard Blood Glucose Monitoring | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 194. | Hyperglycaemia | 0.2 units on a scale | Standard Deviation 1.7 |
| Standard Blood Glucose Monitoring | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 194. | Hypoglycaemia | 0.0 units on a scale | Standard Deviation 1.4 |
| Standard Blood Glucose Monitoring | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 194. | Treatment Satisfaction | 9.6 units on a scale | Standard Deviation 5.6 |
Comparison: Perceived frequency of hyperglycaemiap-value: 0.6075ANCOVA
Comparison: Perceived frequency of hypoglycaemiap-value: 0.2295ANCOVA
Comparison: Total treatment satisfaction scorep-value: <0.001ANCOVA
Secondary
Frequency of Episodes <70 mg/dL and <55 mg/dL
Difference in frequency of episodes \<70 mg/dL and \<55 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA.
Time frame: Baseline and Days 194 to 208
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor Based Glucose Monitoring System | Frequency of Episodes <70 mg/dL and <55 mg/dL | Frequency of episodes <70 mg/dL, Baseline | 0.64 number of episodes per day | Standard Deviation 0.63 |
| Sensor Based Glucose Monitoring System | Frequency of Episodes <70 mg/dL and <55 mg/dL | Frequency of episodes <55 mg/dL, Baseline | 0.34 number of episodes per day | Standard Deviation 0.5 |
| Sensor Based Glucose Monitoring System | Frequency of Episodes <70 mg/dL and <55 mg/dL | Frequency of episodes <55 mg/dL, Days 194-208 | 0.14 number of episodes per day | Standard Deviation 0.24 |
| Sensor Based Glucose Monitoring System | Frequency of Episodes <70 mg/dL and <55 mg/dL | Frequency of episodes <70 mg/dL, Days 194-208 | 0.38 number of episodes per day | Standard Deviation 0.45 |
| Standard Blood Glucose Monitoring | Frequency of Episodes <70 mg/dL and <55 mg/dL | Frequency of episodes <55 mg/dL, Days 194-208 | 0.24 number of episodes per day | Standard Deviation 0.36 |
| Standard Blood Glucose Monitoring | Frequency of Episodes <70 mg/dL and <55 mg/dL | Frequency of episodes <70 mg/dL, Baseline | 0.63 number of episodes per day | Standard Deviation 0.66 |
| Standard Blood Glucose Monitoring | Frequency of Episodes <70 mg/dL and <55 mg/dL | Frequency of episodes <70 mg/dL, Days 194-208 | 0.53 number of episodes per day | Standard Deviation 0.59 |
| Standard Blood Glucose Monitoring | Frequency of Episodes <70 mg/dL and <55 mg/dL | Frequency of episodes <55 mg/dL, Baseline | 0.27 number of episodes per day | Standard Deviation 0.44 |
Comparison: Statistical analysis of frequency of episodes \<70 mg/dLp-value: 0.0164ANCOVA
Comparison: Statistical analysis of frequency of episodes \<55 mg/dLp-value: 0.0017ANCOVA
Secondary
Number of Glucose Measurements Performed
Number of blood glucose fingerstick tests per day by intervention and control group during days 15 to 208. The number of sensor scans performed by the intervention group during days 15 to 208.
Time frame: Days 15 to 208
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor Based Glucose Monitoring System | Number of Glucose Measurements Performed | Number of fingerstick tests, Days 194-208 | 0.4 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 | 8.3 number of measurements per day | Standard Deviation 4.4 |
| Standard Blood Glucose Monitoring | Number of Glucose Measurements Performed | Number of fingerstick tests, Days 194-208 | 3.8 number of measurements per day | Standard Deviation 1.9 |
| 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
Sensor utilisation assessed by percentage of sensor glucose data collected by the intervention group.
Time frame: Days 15 to 208
Population: 138 subjects included in the analysis, 11 were not included due to missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensor Based Glucose Monitoring System | System Utilisation | 88.7 percentage of sensor glucose collected | Standard Deviation 9.2 |
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) using ANCOVA.
Time frame: Baseline and Days 194 to 208
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor Based Glucose Monitoring System | Time in Range | Baseline | 13.9 hours per day | Standard Deviation 4.5 |
| Sensor Based Glucose Monitoring System | Time in Range | Days 194-208 | 13.6 hours per day | Standard Deviation 4.6 |
| Standard Blood Glucose Monitoring | Time in Range | Baseline | 13.5 hours per day | Standard Deviation 5.2 |
| Standard Blood Glucose Monitoring | Time in Range | Days 194-208 | 13.2 hours per day | Standard Deviation 4.9 |
p-value: 0.7925ANCOVA
Secondary
Time Spent >180 mg/dL and >240 mg/dL
Difference in time \>180 mg/dL and \>240mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA.
Time frame: Baseline and Days 194 to 208
| 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 | 8.8 hours per day | Standard Deviation 5 |
| Sensor Based Glucose Monitoring System | Time Spent >180 mg/dL and >240 mg/dL | Time spent >180 mg/dL, Days 194-208 | 9.8 hours per day | Standard Deviation 4.8 |
| Sensor Based Glucose Monitoring System | Time Spent >180 mg/dL and >240 mg/dL | Time spent >240 mg/dL, Baseline | 3.1 hours per day | Standard Deviation 3.3 |
| Sensor Based Glucose Monitoring System | Time Spent >180 mg/dL and >240 mg/dL | Time spent >240 mg/dL, Days 194-208 | 3.5 hours per day | Standard Deviation 3.7 |
| Standard Blood Glucose Monitoring | Time Spent >180 mg/dL and >240 mg/dL | Time spent >240 mg/dL, Days 194-208 | 3.9 hours per day | Standard Deviation 4.2 |
| Standard Blood Glucose Monitoring | Time Spent >180 mg/dL and >240 mg/dL | Time spent >180 mg/dL, Baseline | 9.4 hours per day | Standard Deviation 5.8 |
| Standard Blood Glucose Monitoring | Time Spent >180 mg/dL and >240 mg/dL | Time spent >240 mg/dL, Baseline | 3.9 hours per day | Standard Deviation 4.5 |
| Standard Blood Glucose Monitoring | Time Spent >180 mg/dL and >240 mg/dL | Time spent >180 mg/dL, Days 194-208 | 9.8 hours per day | Standard Deviation 5.4 |
Comparison: Statistical analysis of time spent \>180 mg/dLp-value: 0.597ANCOVA
Comparison: Statistical analysis of time spent \>240 mg/dLp-value: 0.8729ANCOVA
Secondary
Time Spent <70 mg/dL and <55 mg/dL
Difference in time \<70 mg/dL and \<55 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA.
Time frame: Baseline and Days 194 to 208
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor Based Glucose Monitoring System | Time Spent <70 mg/dL and <55 mg/dL | Time spent <70 mg/dL, Baseline | 1.30 hours per day | Standard Deviation 1.78 |
| Sensor Based Glucose Monitoring System | Time Spent <70 mg/dL and <55 mg/dL | Time spent <55 mg/dL, Baseline | 0.59 hours per day | Standard Deviation 1.13 |
| Sensor Based Glucose Monitoring System | Time Spent <70 mg/dL and <55 mg/dL | Time spent <70 mg/dL, Days 194-208 | 0.59 hours per day | Standard Deviation 0.82 |
| Sensor Based Glucose Monitoring System | Time Spent <70 mg/dL and <55 mg/dL | Time spent <55 mg/dL, Days 194-208 | 0.19 hours per day | Standard Deviation 0.37 |
| Standard Blood Glucose Monitoring | Time Spent <70 mg/dL and <55 mg/dL | Time spent <55 mg/dL, Days 194-208 | 0.37 hours per day | Standard Deviation 0.69 |
| Standard Blood Glucose Monitoring | Time Spent <70 mg/dL and <55 mg/dL | Time spent <70 mg/dL, Baseline | 1.08 hours per day | Standard Deviation 1.58 |
| Standard Blood Glucose Monitoring | Time Spent <70 mg/dL and <55 mg/dL | Time spent <70 mg/dL, Days 194-208 | 0.99 hours per day | Standard Deviation 1.29 |
| Standard Blood Glucose Monitoring | Time Spent <70 mg/dL and <55 mg/dL | Time spent <55 mg/dL, Baseline | 0.38 hours per day | Standard Deviation 0.83 |
Comparison: Statistical analysis of time spent \<70 mg/dLp-value: <0.001ANCOVA
Comparison: Statistical analysis of time spent \<55 mg/dLp-value: 0.0014ANCOVA