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

February 4, 2016 updated by: Abbott Diabetes Care

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Ashton-under-Lyne, United Kingdom, OL6 9RW
        • Tameside Hospital NHS Foundation Trust
      • Bath, United Kingdom, BA1 3NG
        • Royal United Hospital
      • City and Borough of Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital, Diabetes Clinic
      • Durham, United Kingdom, DH1 5TW
        • University Hospital of North Durham
      • Ipswich, United Kingdom, IP4 5PD
        • Ipswich Hospital NHS Trust
      • Leeds, United Kingdom, LS9 7TF
        • St James Hospital,
      • Rotherham, United Kingdom, S60 2UD
        • Rotherham General Hospital
      • Wolverhampton,, United Kingdom, WV10 0QP
        • Diabetes Centre, New Cross Hospital,
    • Ayrshire
      • Ayr, Ayrshire, United Kingdom, KA6 6DX
        • Ayr Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: FreeStyle Navigator
Masked CGM day 1 to 15, unmasked CGM days 15 to 100
Active Comparator: 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.
Device: Standard SMBG
Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 86 to 100 compared to Day 1 to 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in Range
Time Frame: Days 86 to 100 intervention arm compared to control arm
Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm.
Days 86 to 100 intervention arm compared to control arm
Glucose Standard Deviation (SD)
Time Frame: Day 86 to 100 compared to day 1 to 15
Day 86 to 100 compared to day 1 to 15
HbA1c (mmol/Mol)
Time Frame: Day 100 compared to day 1
Day 100 compared to day 1
HbA1c
Time Frame: Day 100 compared to day 1
Day 100 compared to day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Diabetes Care

Investigators

  • Principal Investigator: Ramzi Ajjan, St James Hospital, Leeds

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

October 22, 2012

First Submitted That Met QC Criteria

October 22, 2012

First Posted (Estimate)

October 24, 2012

Study Record Updates

Last Update Posted (Estimate)

March 4, 2016

Last Update Submitted That Met QC Criteria

February 4, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADC-PMR-APO-12015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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