Diabetes Mellitus
Conditions
Keywords
CGM, MDI
Brief summary
To understand if Multiple Daily Injections (MDI) managed subjects can improve glycaemic control by; 1. regularly checking and understanding Continuous Glucose data & trend arrows at times other than the standard pre-meal bolus calculation test times and 2. review of their glucose profiles (inc. hypoglycaemic risks) with their Health Care Professional (HCP) and adjusting behaviours & therapy from interpretation of the Continuous Glucose profiles.
Interventions
DEVICEFreeStyle Navigator
Masked CGM day 1 to 15, unmasked CGM days 15 to 100
DEVICEStandard SMBG
Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
Sponsors
Abbott Diabetes Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years and over * Type 1 diabetes on MDI with bolus injections for \>6 months prior to study enrolment or Type 2 diabetes treated with 2 or more insulin injections daily. * In the investigator's opinion, thought technically capable of using FreeStyle Navigator GM System device. * HbA1c between 7.5 and 12.0% (58 to 108 mmol/mol) for previous test obtained within 6 months prior to point of enrolment
Exclusion criteria
* Concomitant disease or condition that may compromise patient safety, including unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any uncontrolled chronic medical condition * Female subject is pregnant or planning to become pregnant within the planned study duration. Subjects who become pregnant during the study will be discontinued from the study. * Currently using / has previously used a Continuous Glucose Monitoring System within the last 6 months. * Currently using Continuous Subcutaneous Insulin Infusion (CSII) * Currently using basal/long acting insulin only. * Participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management * Known allergy to medical grade adhesives * In the investigators opinion is unsuitable to participate due to any other cause/reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range | Day 86 to 100 compared to Day 1 to 15 | Intervention arm: within subject difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) in final 15 days compared to baseline phase assessed separately for Type 1 and Type 2 Diabetes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range | Days 86 to 100 intervention arm compared to control arm | Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm. |
| Glucose Standard Deviation (SD) | Day 86 to 100 compared to day 1 to 15 | — |
| HbA1c (mmol/Mol) | Day 100 compared to day 1 | — |
| HbA1c | Day 100 compared to day 1 | — |
Countries
United Kingdom
Participant flow
Pre-assignment details
A total of 105 subjects consented and enrolled into the study. Eighteen of these withdrew before randomisation or failed screening. Eighty-seven (87) subjects were randomised and 79 completed the study.
Participants by arm
| Arm | Count |
|---|---|
| CGM - Intervention Arm - Type 1 Diabetes Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100 | 29 |
| SMBG - Control Arm - Type 1 Diabetes Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100 | 13 |
| CGM - Intervention Arm - Type 2 Diabetes Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100 | 30 |
| SMBG - Control Arm - Type 2 Diabetes Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100 | 15 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 2 | 2 | 0 |
Baseline characteristics
| Characteristic | CGM - Intervention Arm - Type 1 Diabetes | SMBG - Control Arm - Type 1 Diabetes | CGM - Intervention Arm - Type 2 Diabetes | SMBG - Control Arm - Type 2 Diabetes | Total |
|---|---|---|---|---|---|
| Age, Continuous | 39.0 years STANDARD_DEVIATION 11.5 | 43.7 years STANDARD_DEVIATION 9.9 | 57.8 years STANDARD_DEVIATION 8.8 | 55.5 years STANDARD_DEVIATION 10.9 | 49.0 years STANDARD_DEVIATION 13.2 |
| Baseline HbA1c | 9.2 % STANDARD_DEVIATION 1.3 | 9.0 % STANDARD_DEVIATION 1.3 | 9.2 % STANDARD_DEVIATION 1.4 | 9.2 % STANDARD_DEVIATION 1.3 | 76.4 mmol/mol STANDARD_DEVIATION 14.1 |
| Region of Enrollment United Kingdom | 29 participants | 13 participants | 30 participants | 15 participants | 87 participants |
| Sex: Female, Male Female | 14 Participants | 7 Participants | 11 Participants | 4 Participants | 36 Participants |
| Sex: Female, Male Male | 15 Participants | 6 Participants | 19 Participants | 11 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 29 | 7 / 13 | 17 / 30 | 8 / 15 |
| serious Total, serious adverse events | 1 / 29 | 0 / 13 | 0 / 30 | 1 / 15 |
Outcome results
Primary
Time in Range
Intervention arm: within subject difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) in final 15 days compared to baseline phase assessed separately for Type 1 and Type 2 Diabetes.
Time frame: Day 86 to 100 compared to Day 1 to 15
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CGM - Intervention Arm - Type 1 Diabetes | Time in Range | Final | 10.8 hours per day | Standard Deviation 3.9 |
| CGM - Intervention Arm - Type 1 Diabetes | Time in Range | Baseline | 10.9 hours per day | Standard Deviation 3 |
| SMBG - Control Arm - Type 1 Diabetes | Time in Range | Final | 11.5 hours per day | Standard Deviation 4.2 |
| SMBG - Control Arm - Type 1 Diabetes | Time in Range | Baseline | 11.5 hours per day | Standard Deviation 4.6 |
| CGM - Intervention Arm - Type 2 Diabetes | Time in Range | Baseline | 13.3 hours per day | Standard Deviation 5.2 |
| CGM - Intervention Arm - Type 2 Diabetes | Time in Range | Final | 14.7 hours per day | Standard Deviation 5.8 |
| SMBG - Control Arm - Type 2 Diabetes | Time in Range | Final | 13.3 hours per day | Standard Deviation 5.5 |
| SMBG - Control Arm - Type 2 Diabetes | Time in Range | Baseline | 12.3 hours per day | Standard Deviation 7 |
p-value: 0.934595% CI: [-1.29, 1.19]t-test, 2 sided
Comparison: Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm.p-value: 0.042795% CI: [0.05, 2.73]t-test, 2 sided
Secondary
Glucose Standard Deviation (SD)
Time frame: Day 86 to 100 compared to day 1 to 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CGM - Intervention Arm - Type 1 Diabetes | Glucose Standard Deviation (SD) | Baseline | 4.0 mmol/L | Standard Deviation 0.8 |
| CGM - Intervention Arm - Type 1 Diabetes | Glucose Standard Deviation (SD) | Final | 3.8 mmol/L | Standard Deviation 0.7 |
| SMBG - Control Arm - Type 1 Diabetes | Glucose Standard Deviation (SD) | Final | 3.8 mmol/L | Standard Deviation 0.6 |
| SMBG - Control Arm - Type 1 Diabetes | Glucose Standard Deviation (SD) | Baseline | 3.7 mmol/L | Standard Deviation 0.8 |
| CGM - Intervention Arm - Type 2 Diabetes | Glucose Standard Deviation (SD) | Baseline | 3.0 mmol/L | Standard Deviation 0.7 |
| CGM - Intervention Arm - Type 2 Diabetes | Glucose Standard Deviation (SD) | Final | 2.8 mmol/L | Standard Deviation 0.7 |
| SMBG - Control Arm - Type 2 Diabetes | Glucose Standard Deviation (SD) | Baseline | 3.1 mmol/L | Standard Deviation 1 |
| SMBG - Control Arm - Type 2 Diabetes | Glucose Standard Deviation (SD) | Final | 3.0 mmol/L | Standard Deviation 0.6 |
p-value: 0.035295% CI: [-0.51, -0.02]t-test, 2 sided
p-value: 0.050695% CI: [-0.54, 0]t-test, 2 sided
Secondary
HbA1c
Time frame: Day 100 compared to day 1
Population: Analysis performed according to the intention-to-treat principle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CGM - Intervention Arm - Type 1 Diabetes | HbA1c | Baseline | 9.0 Percent | Standard Deviation 0.9 |
| CGM - Intervention Arm - Type 1 Diabetes | HbA1c | Final | 8.7 Percent | Standard Deviation 0.7 |
| SMBG - Control Arm - Type 1 Diabetes | HbA1c | Final | 8.9 Percent | Standard Deviation 1.3 |
| SMBG - Control Arm - Type 1 Diabetes | HbA1c | Baseline | 9.0 Percent | Standard Deviation 1.3 |
| CGM - Intervention Arm - Type 2 Diabetes | HbA1c | Baseline | 9.2 Percent | Standard Deviation 1.4 |
| CGM - Intervention Arm - Type 2 Diabetes | HbA1c | Final | 8.3 Percent | Standard Deviation 1.2 |
| SMBG - Control Arm - Type 2 Diabetes | HbA1c | Baseline | 9.2 Percent | Standard Deviation 1.3 |
| SMBG - Control Arm - Type 2 Diabetes | HbA1c | Final | 8.8 Percent | Standard Deviation 0.8 |
p-value: 0.05895% CI: [-0.59, 0.01]t-test, 2 sided
p-value: 0.000295% CI: [-1.24, -0.45]t-test, 2 sided
Secondary
HbA1c (mmol/Mol)
Time frame: Day 100 compared to day 1
Population: Analysis performed according to the intention-to-treat principle. Analysis in the Type 1 population is after removal of 1 outlier.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CGM - Intervention Arm - Type 1 Diabetes | HbA1c (mmol/Mol) | Baseline | 75 mmol/mol | Standard Deviation 10 |
| CGM - Intervention Arm - Type 1 Diabetes | HbA1c (mmol/Mol) | Final | 72 mmol/mol | Standard Deviation 8 |
| SMBG - Control Arm - Type 1 Diabetes | HbA1c (mmol/Mol) | Final | 74 mmol/mol | Standard Deviation 14 |
| SMBG - Control Arm - Type 1 Diabetes | HbA1c (mmol/Mol) | Baseline | 75 mmol/mol | Standard Deviation 14 |
| CGM - Intervention Arm - Type 2 Diabetes | HbA1c (mmol/Mol) | Baseline | 77 mmol/mol | Standard Deviation 15 |
| CGM - Intervention Arm - Type 2 Diabetes | HbA1c (mmol/Mol) | Final | 67 mmol/mol | Standard Deviation 13 |
| SMBG - Control Arm - Type 2 Diabetes | HbA1c (mmol/Mol) | Baseline | 77 mmol/mol | Standard Deviation 14 |
| SMBG - Control Arm - Type 2 Diabetes | HbA1c (mmol/Mol) | Final | 72 mmol/mol | Standard Deviation 9 |
p-value: 0.05895% CI: [-6.4, 0.1]t-test, 2 sided
p-value: 0.000295% CI: [-13.6, -4.9]t-test, 2 sided
Secondary
Time in Range
Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm.
Time frame: Days 86 to 100 intervention arm compared to control arm
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CGM - Intervention Arm - Type 1 Diabetes | Time in Range | Baseline | 10.9 hours per day | Standard Deviation 3 |
| CGM - Intervention Arm - Type 1 Diabetes | Time in Range | Final | 10.8 hours per day | Standard Deviation 3.9 |
| SMBG - Control Arm - Type 1 Diabetes | Time in Range | Final | 11.5 hours per day | Standard Deviation 4.2 |
| SMBG - Control Arm - Type 1 Diabetes | Time in Range | Baseline | 11.5 hours per day | Standard Deviation 4.6 |
| CGM - Intervention Arm - Type 2 Diabetes | Time in Range | Baseline | 13.3 hours per day | Standard Deviation 5.2 |
| CGM - Intervention Arm - Type 2 Diabetes | Time in Range | Final | 14.7 hours per day | Standard Deviation 5.8 |
| SMBG - Control Arm - Type 2 Diabetes | Time in Range | Baseline | 12.3 hours per day | Standard Deviation 7 |
| SMBG - Control Arm - Type 2 Diabetes | Time in Range | Final | 13.3 hours per day | Standard Deviation 5.5 |
p-value: 0.836795% CI: [-2.65, 2.16]ANCOVA
p-value: 0.796995% CI: [-1.86, 2.4]ANCOVA