CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 105 enrolled
Drug / intervention
FreeStyle Navigator +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01713348
NCT01713348Phase 4Completed
CompareCT.gov

Sensor and Software Use for Improved Glucose Control in MDI Managed Diabetes

Abbott Diabetes Care·interventional·Posted Oct 24, 2012·Updated Mar 4, 2016

In Brief

A Phase 4 clinical trial evaluating FreeStyle Navigator and Standard SMBG for Diabetes Mellitus. Completed, enrolled 105 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 24, 2012
Enrollment StartOct 1, 2012
Primary CompletionMay 1, 2013
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 13.7 years ago

Interventions

FreeStyle Navigatordevice

Masked CGM day 1 to 15, unmasked CGM days 15 to 100

Standard SMBGdevice

Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100