NCT01214824

Brief Summary

To demonstrate that in patients with persistent poorly controlled diabetes, short/intermittent use of continuous glucose monitoring can driver better longer-term glycaemic control and HbA1c.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2010

Completed
27 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1 year until next milestone

Results Posted

Study results publicly available

June 6, 2013

Completed
Last Updated

July 2, 2013

Status Verified

June 1, 2013

Enrollment Period

1.3 years

First QC Date

October 4, 2010

Results QC Date

March 1, 2013

Last Update Submit

June 21, 2013

Conditions

Diabetes Mellitus

Keywords

DiabetesContinuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1C From Baseline to 6 Months

    HbA1c at baseline HbA1c at 6 months Change in HbA1c(%)(6 months - baseline)

    Baseline and 6 months

Secondary Outcomes (3)

  • Number of Subjects Who Had Reduction in HbA1c of > or = 0.5%

    Baseline and 6 months

  • Proportion of Time in Hypoglycaemia (<3.9 mmol/L)- Masked

    Baseline & 6 months

  • Proportion of Time in Hypoglycaemia (<3.9mmol/L)-Unmasked

    2 weeks following baseline & 3 months

Interventions

FreeStyle Navigator Continuous Glucose Monitoring SystemDEVICE

Six x 5 day wears of the continuous glucose monitoring device. Two of the 6 wears will be using a masked device (1 at the start and 1 at the end of the study).

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject with Type 1 or Type 2 diabetes requiring Multiple Daily Injections (MDI) (for \>1yr)
  • Age 18-65 years
  • HbA1c above 8.0% for previous 2 HbA1c tests; the last HbA1c result being obtained within 3 months prior to enrolment
  • Completed a structured education programme meeting NICE criteria between 6 to 24 months prior to enrolment.
  • Testing Blood Glucose ≥ 4 times a day for previous 12 months

You may not qualify if:

  • Subject is currently on an insulin pump.
  • Subject has known allergy to medical grade adhesives
  • Subject has concomitant disease that influences metabolic control
  • Subject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management
  • Subject is currently using another continuous glucose monitoring device or has previously used real-time continuous glucose monitoring.
  • Subject is receiving peritoneal dialysis solutions containing icodextrin
  • Subject is pregnant / planning to become pregnant during study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Ayr Hospital

Ayr, Ayrshire, KA6 6DX, United Kingdom

Location

The Royal Liverpool University Hospital

Liverpool, Cheshire, L7 8XP, United Kingdom

Location

University Hospital Aintree

Liverpool, Cheshire, L9 7AL, United Kingdom

Location

Glan Clywd Hospital

Rhyl, Denbighshire, LL18 5UJ, United Kingdom

Location

St. John's Hospital

Livingston, Edinburgh, EH54 6PP, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

After an enrolment review recruitment was ceased on 02 Sep 11 with only 32/50 enrolled subjects. The screening/recruitment phase had been 12 weeks but was significantly extended. Only 7/32 subjects had completed 6 month HbA1c when recruitment ceased.

Results Point of Contact

Title
Director Global Clinical and EMEA Regulatory Affairs
Organization
Abbott Diabetes Care
joe.bugler@abbott.com
01993863164

Study Officials

  • Jiten Vora, MRCP

    The Royal Liverpool and Broadgreen University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2010

First Posted

October 5, 2010

Study Start

November 1, 2010

Primary Completion

February 1, 2012

Study Completion

June 1, 2012

Last Updated

July 2, 2013

Results First Posted

June 6, 2013

Record last verified: 2013-06

Locations

GB(5)