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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care
ClinicalTrials.gov Identifier:
NCT01713348
First received: October 22, 2012
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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 HCP and adjusting behaviours & therapy from interpretation of the Continuous Glucose profiles.

Condition Intervention Phase
Diabetes Mellitus
 Device: FreeStyle Navigator
Device: Standard SMBG
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Sensor and Software Use for Improved Glucose Control in MDI Managed Diabetes

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Abbott Diabetes Care:

Primary Outcome Measures:
  • Time in range [ Time Frame: Day 86 to 100 compared to Day 1 to 15 ] [ Designated as safety issue: No ]
    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 T1/T2.


Secondary Outcome Measures:
  • Difference in time in range [ Time Frame: Days 86 to 100 compared to day 1 to 15 ] [ Designated as safety issue: No ]
    Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm.

  • Hypoglycaemia [ Time Frame: Day 86 to 100 compared to day 1 to 15 ] [ Designated as safety issue: No ]
    Number of excursions and duration (number of hours) of hypoglycaemia events per day.

  • Hyperglycaemia [ Time Frame: Day 86 to 100 compared to day 1 to 15 ] [ Designated as safety issue: No ]
    Number of excursions and duration (number of hours) of hyperglycaemia events per day.

  • Time in Hypoglycaemia and Hyperglycaemia [ Time Frame: Day 86 to 100 compared to day 1 to 15 ] [ Designated as safety issue: No ]
    Time outside glucose range (70-180 mg/dL, 3.9 to 10.0 mmol/L).

  • Mean Glucose [ Time Frame: Day 86 to 100 compared to day 1 to 15 ] [ Designated as safety issue: No ]
    Mean Glucose

  • Glycaemic variability [ Time Frame: Day 86 to 100 compared to day 1 to 15 ] [ Designated as safety issue: No ]
    Any changes in glycaemic control or variability

  • Frequency of blood glucose testing [ Time Frame: Day 86 to 100 compared to day 1 to 15 ] [ Designated as safety issue: No ]
    Any changes or differences in frequency of blood glucose testing

  • HbA1c, fructosamine and lipid profiles [ Time Frame: Day 100 compared to day 1 ] [ Designated as safety issue: No ]
    Laboratory blood chemistry tests to provide a measure of glycaemic control.

  • DTSQ [ Time Frame: Day 86 compared to day 1 ] [ Designated as safety issue: No ]
    Scores for the for the Diabetes Treatment Satisfaction Questionnaire (DTSQ),status version and changes version compared for each study group.


Estimated Enrollment: 90
Study Start Date: October 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CGM - intervention arm
Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator.
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713348

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

No publications provided

Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT01713348     History of Changes
Other Study ID Numbers: ADC-PMR-APO-12015
Study First Received: October 22, 2012
Last Updated: February 12, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Abbott Diabetes Care:
CGM
MDI

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013