Diabetes Mellitus
Conditions
Keywords
Diabetes, Continuous Glucose Monitoring
Brief summary
To demonstrate that in patients with persistent poorly controlled diabetes, short/intermittent use of continuous glucose monitoring can driver better longer-term glycaemic control and HbA1c.
Detailed description
Study Overview This is a multi-centre pilot study across 6 study sites, recruiting 50 subjects. Each subject will use a FreeStyle Navigator Continuous Glucose Monitor for a period of 20 days at the start of the study, after which their Healthcare Professionals (HCPs) may recommend changes to their glucose management based on the continuous glucose monitoring(CGM) data. Subjects will then return to self-managing their diabetes with a blood glucose meter. After 2 months, subjects will use the FreeStyle Navigator for a further 5 days and review their results and glucose management with their HCPs. Subjects will again return to self-managing their diabetes with a blood glucose meter until the end of the study, when the last FreeStyle Navigator 5 day wear is completed and HbA1c and measures of glycaemic variability are recorded.
Interventions
Six x 5 day wears of the continuous glucose monitoring device. Two of the 6 wears will be using a masked device (1 at the start and 1 at the end of the study).
Sponsors
Liverpool University Hospitals NHS Foundation Trust
National Heatlh Service Ayrshire and Arran
NHS Lothian
National Health Service, United Kingdom
Cardiff and Vale University Health Board
Abbott Diabetes Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subject with Type 1 or Type 2 diabetes requiring Multiple Daily Injections (MDI) (for \>1yr) * Age 18-65 years * HbA1c above 8.0% for previous 2 HbA1c tests; the last HbA1c result being obtained within 3 months prior to enrolment * Completed a structured education programme meeting NICE criteria between 6 to 24 months prior to enrolment. * Testing Blood Glucose ≥ 4 times a day for previous 12 months
Exclusion criteria
* Subject is currently on an insulin pump. * Subject has known allergy to medical grade adhesives * Subject has concomitant disease that influences metabolic control * Subject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management * Subject is currently using another continuous glucose monitoring device or has previously used real-time continuous glucose monitoring. * Subject is receiving peritoneal dialysis solutions containing icodextrin * Subject is pregnant / planning to become pregnant during study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1C From Baseline to 6 Months | Baseline and 6 months | HbA1c at baseline HbA1c at 6 months Change in HbA1c(%)(6 months - baseline) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Had Reduction in HbA1c of > or = 0.5% | Baseline and 6 months | Number of subjects with a HbA1c reduction greater than or equal to 0.5% and 95% confidence interval from visit 1 (baseline) to visit 7 (6 months). |
| Proportion of Time in Hypoglycaemia (<3.9 mmol/L)- Masked | Baseline & 6 months | Proportion of time (hours per day) in hypoglycaemia (\<3.9 mmol/L) for the masked phase. There were two masked phases in the study, one 5 day wear at baseline and one 5 day wear at 6 months. During masked wear subject were not able to see continuous glucose data from the device. |
| Proportion of Time in Hypoglycaemia (<3.9mmol/L)-Unmasked | 2 weeks following baseline & 3 months | Proportion of time (hours per day) in hypoglycaemia (\<3.9mmol/L) for the unmasked phase |
Countries
United Kingdom
Participant flow
Recruitment details
Participants with type 1 or type 2 diabetes on Multiple Daily Injection(MDI)of insulin(3 or more injections per day)with an HbA1c of 8% or more for their last two tests were recruited at five sites across the United Kingdom. The target enrolment was 50 subjects, with the aim of completing the study with 40 subjects for statistical analysis.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Participants using the FreeStyle Navigator System Intermittently | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Intervention Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants |
| Age Continuous | 42.5 years |
| Body Mass Index (BMI) | 26.3 kg/m^2 |
| Daily Total Insulin Dosage-Basal | 24.9 Units |
| Daily Total Insulin Dosage-Bolus | 28.0 Units |
| HbA1c | 9.3 % |
| Number of blood glucose measurements per day | 4.5 Tests |
| Number of injections per day | 4.1 Injections |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 9 Participants |
| Weight | 73.7 Kg |
| Years since diagnosis | 17.6 Years |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 32 |
| serious Total, serious adverse events | 3 / 32 |
Outcome results
Primary
Change in HbA1C From Baseline to 6 Months
HbA1c at baseline HbA1c at 6 months Change in HbA1c(%)(6 months - baseline)
Time frame: Baseline and 6 months
Population: Intention to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Change in HbA1C From Baseline to 6 Months | 6 months | 9.1 HbA1c % | Standard Deviation 1.3 |
| Intervention Group | Change in HbA1C From Baseline to 6 Months | Baseline | 9.3 HbA1c % | Standard Deviation 1.3 |
Comparison: Comparison is HbA1c at 6 months versus Baselinep-value: 0.014Wilcoxon signed rank test
Secondary
Number of Subjects Who Had Reduction in HbA1c of > or = 0.5%
Number of subjects with a HbA1c reduction greater than or equal to 0.5% and 95% confidence interval from visit 1 (baseline) to visit 7 (6 months).
Time frame: Baseline and 6 months
Population: Intention to treat analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Number of Subjects Who Had Reduction in HbA1c of > or = 0.5% | 14 participants |
Secondary
Proportion of Time in Hypoglycaemia (<3.9 mmol/L)- Masked
Proportion of time (hours per day) in hypoglycaemia (\<3.9 mmol/L) for the masked phase. There were two masked phases in the study, one 5 day wear at baseline and one 5 day wear at 6 months. During masked wear subject were not able to see continuous glucose data from the device.
Time frame: Baseline & 6 months
Population: Analysis per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Proportion of Time in Hypoglycaemia (<3.9 mmol/L)- Masked | Time in hypoglycaemia (<3.9mmol/L)-masked phase 1 | 0.93 Hours per day | Standard Deviation 0.84 |
| Intervention Group | Proportion of Time in Hypoglycaemia (<3.9 mmol/L)- Masked | Time in hypoglycaemia (<3.9mmol/L)-masked phase 2 | 1.06 Hours per day | Standard Deviation 1.02 |
Comparison: Comparison is masked phase 2 versus masked phase 1p-value: 0.5304Paired t-test
Secondary
Proportion of Time in Hypoglycaemia (<3.9mmol/L)-Unmasked
Proportion of time (hours per day) in hypoglycaemia (\<3.9mmol/L) for the unmasked phase
Time frame: 2 weeks following baseline & 3 months
Population: Analysis per protocol 31 participants analysed in the unmasked phase 1 28 participants analysed in the unmasked phase 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Proportion of Time in Hypoglycaemia (<3.9mmol/L)-Unmasked | Time in hypoglycaemia(3.9mmol/L)unmasked phase 1 | 0.60 Hours per day | Standard Deviation 0.47 |
| Intervention Group | Proportion of Time in Hypoglycaemia (<3.9mmol/L)-Unmasked | Time in hypoglycaemia(3.9mmol/L)unmasked phase 2 | 0.49 Hours per day | Standard Deviation 0.55 |