N/A
Completed N=49
Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study
Source: ClinicalTrials.gov NCT01519466 ↗Enrolled (actual)
49
Serious AEs
10.2%
Results posted
Apr 2016
Primary outcomePrimary: Time in Target Blood Glucose Range — 15.28; 15.31; 14.56; 14.14 hours per day — p=0.0926
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time in Target Blood Glucose Range |
15.28; 15.31; 14.56; 14.14 | 0.0926 |
| SECONDARY HbA1c |
7.87; 8.07; 7.78; 7.98 | 0.3251 |
| SECONDARY Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60. |
0.13; -0.25; -0.31; 0.13; 4.36; 2.94 | 0.5798 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01519466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.