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

Abbott

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus

Treatments: Device: Standard SMBG; Device: FreeStyle Navigator

Study type: Interventional

Funder types: Industry

Identifiers

NCT01713348

ADC-PMR-APO-12015

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

105 participants in 2 patient groups

CGM - intervention arm

Experimental group

Description:

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

Treatment:

Device: FreeStyle Navigator

SMBG - Control arm

Active Comparator group

Description:

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.

Treatment:

Device: Standard SMBG