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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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CGM - intervention arm

Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.

Group Type EXPERIMENTAL

FreeStyle Navigator

Intervention Type DEVICE

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

SMBG - Control arm

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.

Group Type ACTIVE_COMPARATOR

Standard SMBG

Intervention Type DEVICE

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

Interventions

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FreeStyle Navigator

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

Intervention Type DEVICE

Standard SMBG

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No