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OpenTrials
Completed

NCT Number: NCT01713348

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

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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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ayr Hospital, Ayr, Ayrshire, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Freestyle Navigator

Device

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

Standard SMBG

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Glucose Standard Deviation (SD)

    Time frame: Day 86 to 100 compared to day 1 to 15

  3. HbA1c (mmol/Mol)

    Time frame: Day 100 compared to day 1

  4. HbA1c

    Time frame: Day 100 compared to day 1

Sponsors and collaborators

Lead sponsor

Abbott Diabetes Care

Industry

Registry information

Acronym: SIGN

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 24, 2012
Registry last updated
Mar 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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