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

Diabetes Mellitus Clinical Trial

— SIGN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01713348
• Other study ID #: ADC-PMR-APO-12015
• Status: Completed
• Phase: Phase 4
• First received: October 22, 2012
• Last updated: February 4, 2016
• Start date: October 2012
• Est. completion date: July 2013

Study information

• Verified date: February 2016
• Source: Abbott Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• FreeStyle Navigator
Masked CGM day 1 to 15, unmasked CGM days 15 to 100
• Standard SMBG
Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100

Locations

Country	Name	City	State
United Kingdom	Tameside Hospital NHS Foundation Trust	Ashton-under-Lyne
United Kingdom	Ayr Hospital	Ayr	Ayrshire
United Kingdom	Royal United Hospital	Bath
United Kingdom	Birmingham Heartlands Hospital, Diabetes Clinic	City and Borough of Birmingham
United Kingdom	University Hospital of North Durham	Durham
United Kingdom	Ipswich Hospital NHS Trust	Ipswich
United Kingdom	St James Hospital,	Leeds
United Kingdom	Rotherham General Hospital	Rotherham
United Kingdom	Diabetes Centre, New Cross Hospital,	Wolverhampton,

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Diabetes Care

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in Range	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	No
Secondary	Time in Range	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	No
Secondary	Glucose Standard Deviation (SD)		Day 86 to 100 compared to day 1 to 15	No
Secondary	HbA1c (mmol/Mol)		Day 100 compared to day 1	No
Secondary	HbA1c		Day 100 compared to day 1	No