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

Abbott Diabetes Care9 sites in 1 country105 target enrollmentOctober 2012

ConditionsDiabetes Mellitus

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Diabetes Mellitus
Sponsor: Abbott Diabetes Care
Enrollment: 105
Locations: 9
Primary Endpoint: Time in Range
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To understand if Multiple Daily Injections (MDI) managed subjects can improve glycaemic control by;

regularly checking and understanding Continuous Glucose data & trend arrows at times other than the standard pre-meal bolus calculation test times and
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.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

July 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Diabetes Care

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Time in Range

Time Frame: Day 86 to 100 compared to Day 1 to 15

Intervention arm: within subject difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) in final 15 days compared to baseline phase assessed separately for Type 1 and Type 2 Diabetes.