Type 1 Diabetes
Conditions
Keywords
Diabetes, SMBG, Insulin calculator
Brief summary
The purpose of this study is to investigate the effect of using FreeStyle InsuLinx (a blood glucose meter with a built-in insulin calculator) on glucose control in people with type 1 diabetes.
Interventions
DEVICEFreeStyle InsuLinx
FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.
DEVICEFreeStyle Freedom Lite
FreeStyle Freedom Lite is a blood glucose meter
Sponsors
Abbott Diabetes Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject with Type 1 diabetes on MDI (3 or more insulin injections per day (U100 insulin)) for at least 1 year and insulin adjusting * HbA1c between 7.0% and 9.5% (53 to 80 mmol/mol) inclusive * Age 18 and over * In the investigator's opinion, thought technically capable of using masked CGM * Subject self reporting a minimum of 21 SMBG tests per week prior to study enrolment * Willing to perform a minimum of 4 SMBG tests per day during study
Exclusion criteria
* Subject has any concomitant disease or condition that, in the investigator's opinion, may compromise patient safety * Subject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management * Subject is pregnant / planning to become pregnant within the planned study timeline * Subject is known to require a dose of more than 50 units of U100 insulin in any one bolus injection * Subject is currently on an insulin pump * Subject is currently using the FreeStyle InsuLinx * Subject is currently using the FreeStyle Freedom Lite * Subject is currently using CGM * Subject has an allergy to medical grade adhesives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in Target Blood Glucose Range | Day 1-15 compared with Day 60-74 | Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will assess the difference between the assessment and baseline phase for the intervention group. Target blood glucose range is 3.9 to 10.0mmol/l (70 to 180mg/dL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Day 1 compared with Day 74 | HbA1c will be tested at baseline (day 1) and then again at end of study (approximately day 74). The percentage of glycosylated hemoglobin in Diabetes Control and Complications Trial (DCCT) units was standardized to the newer International Federation of Clinical Chemistry (IFCC) units (mmol/mol). |
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60. | Day 60 compared to day 1 | 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 (-3 to +3). 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 satisfaction with perceived frequency of Hypoglycaemia and one question to assess change satisfaction with perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less satisfied) to +3 (much more satisfied). The 95% confidence intervals for the FreeStyle InsuLinx group DTSQc scores was calculated using a one-sample t-test. |
Countries
Germany, Netherlands
Participant flow
Pre-assignment details
A total of 55 subjects consented and enrolled into the study. Six of these withdrew before randomisation or failed screening. Forty-nine (49) subjects were randomised and completed the study.
Participants by arm
| Arm | Count |
|---|---|
| FreeStyle InsuLinx Subjects will use a FreeStyle InsuLinx blood glucose meter during the study
FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature. | 33 |
| FreeStyle Freedom Lite Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.
FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter | 16 |
| Total | 49 |
Baseline characteristics
| Characteristic | FreeStyle InsuLinx | FreeStyle Freedom Lite | Total |
|---|---|---|---|
| Age, Continuous | 44.4 years STANDARD_DEVIATION 15.2 | 43.4 years STANDARD_DEVIATION 16.7 | 44.1 years STANDARD_DEVIATION 15.6 |
| Body Mass Index (BMI) | 26.6 kg/m² STANDARD_DEVIATION 3.6 | 26.4 kg/m² STANDARD_DEVIATION 4.4 | 26.5 kg/m² STANDARD_DEVIATION 3.8 |
| Duration of Diabetes | 18.8 years STANDARD_DEVIATION 14.1 | 14.6 years STANDARD_DEVIATION 8 | 17.4 years STANDARD_DEVIATION 12.5 |
| Region of Enrollment Germany | 25 participants | 12 participants | 37 participants |
| Region of Enrollment Netherlands | 8 participants | 4 participants | 12 participants |
| Screening HbA1c | 7.8 Percentage of Glycosylated Haemoglobin STANDARD_DEVIATION 0.7 | 64.8 mmol/mol STANDARD_DEVIATION 6.8 | 62.7 mmol/mol STANDARD_DEVIATION 7.5 |
| Sex: Female, Male Female | 16 Participants | 7 Participants | 23 Participants |
| Sex: Female, Male Male | 17 Participants | 9 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 33 | 4 / 16 |
| serious Total, serious adverse events | 3 / 33 | 2 / 16 |
Outcome results
Primary
Time in Target Blood Glucose Range
Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will assess the difference between the assessment and baseline phase for the intervention group. Target blood glucose range is 3.9 to 10.0mmol/l (70 to 180mg/dL)
Time frame: Day 1-15 compared with Day 60-74
Population: One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FreeStyle InsuLinx | Time in Target Blood Glucose Range | Baseline | 15.28 hours per day | Standard Deviation 2.76 |
| FreeStyle InsuLinx | Time in Target Blood Glucose Range | Final | 14.56 hours per day | Standard Deviation 2.99 |
| FreeStyle Freedom Lite | Time in Target Blood Glucose Range | Final | 14.14 hours per day | Standard Deviation 2.36 |
| FreeStyle Freedom Lite | Time in Target Blood Glucose Range | Baseline | 15.31 hours per day | Standard Deviation 3.15 |
p-value: 0.092695% CI: [-1.55, 0.12]t-test, 2 sided
Secondary
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60.
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 (-3 to +3). 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 satisfaction with perceived frequency of Hypoglycaemia and one question to assess change satisfaction with perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less satisfied) to +3 (much more satisfied). The 95% confidence intervals for the FreeStyle InsuLinx group DTSQc scores was calculated using a one-sample t-test.
Time frame: Day 60 compared to day 1
Population: One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FreeStyle InsuLinx | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60. | Hyperglycaemia | 0.13 Units on a scale | Standard Deviation 1.26 |
| FreeStyle InsuLinx | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60. | Hypoglycaemia | -0.31 Units on a scale | Standard Deviation 1.03 |
| FreeStyle InsuLinx | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60. | Treatment Satisfaction | 4.36 Units on a scale | Standard Deviation 6.53 |
| FreeStyle Freedom Lite | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60. | Hyperglycaemia | -0.25 Units on a scale | Standard Deviation 1.53 |
| FreeStyle Freedom Lite | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60. | Hypoglycaemia | 0.13 Units on a scale | Standard Deviation 1.02 |
| FreeStyle Freedom Lite | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60. | Treatment Satisfaction | 2.94 Units on a scale | Standard Deviation 7.92 |
Comparison: Hyperglycaemia, glucose above 10mmol/l (180mg/dL)p-value: 0.579895% CI: [-0.33, 0.58]t-test, 2 sided
Comparison: Hypoglycaemia, glucose below 3.9mmol/l (70mg/dL)p-value: 0.09695% CI: [-0.68, 0.06]t-test, 2 sided
Comparison: Treatment Satisfactionp-value: 0.000795% CI: [2.01, 6.71]t-test, 2 sided
Secondary
HbA1c
HbA1c will be tested at baseline (day 1) and then again at end of study (approximately day 74). The percentage of glycosylated hemoglobin in Diabetes Control and Complications Trial (DCCT) units was standardized to the newer International Federation of Clinical Chemistry (IFCC) units (mmol/mol).
Time frame: Day 1 compared with Day 74
Population: One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FreeStyle InsuLinx | HbA1c | Baseline | 7.87 Percentage of Glycosylated Haemoglobin | Standard Deviation 0.76 |
| FreeStyle InsuLinx | HbA1c | Final | 7.78 Percentage of Glycosylated Haemoglobin | Standard Deviation 0.58 |
| FreeStyle Freedom Lite | HbA1c | Baseline | 8.07 Percentage of Glycosylated Haemoglobin | Standard Deviation 0.76 |
| FreeStyle Freedom Lite | HbA1c | Final | 7.98 Percentage of Glycosylated Haemoglobin | Standard Deviation 0.69 |
p-value: 0.325195% CI: [-0.27, 0.09]t-test, 2 sided