Phase 4
Completed N=87
Sensor and Software Use for Improved Glucose Control in MDI Managed Diabetes
Source: ClinicalTrials.gov NCT01713348 ↗Enrolled (actual)
87
Serious AEs
2.3%
Results posted
Mar 2015
Primary outcomePrimary: Time in Range — 10.9; 11.5; 13.3; 12.3 hours per day — p=0.9345
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time in Range |
10.9; 11.5; 13.3; 12.3; 10.8; 11.5 | 0.8367 |
| SECONDARY Time in Range |
10.9; 11.5; 13.3; 12.3; 10.8; 11.5 | 0.8367 |
| SECONDARY Glucose Standard Deviation (SD) |
4.0; 3.7; 3.0; 3.1; 3.8; 3.8 | 0.0352 sig |
| SECONDARY HbA1c (mmol/Mol) |
75; 75; 77; 77; 72; 74 | 0.0580 |
| SECONDARY HbA1c |
9.0; 9.0; 9.2; 9.2; 8.7; 8.9 | 0.0580 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01713348). 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.