NCT01519466

Brief Summary

The purpose of this study is to investigate the effect of using FreeStyle InsuLinx (a blood glucose meter with a built-in insulin calculator) on glucose control in people with type 1 diabetes.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

Geographic Reach
2 countries

4 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

Study Start

First participant enrolled

January 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

April 1, 2016

Completed
Last Updated

April 1, 2016

Status Verified

March 1, 2016

Enrollment Period

9 months

First QC Date

January 6, 2012

Results QC Date

November 12, 2015

Last Update Submit

March 3, 2016

Conditions

Type 1 Diabetes

Keywords

DiabetesSMBGInsulin calculator

Outcome Measures

Primary Outcomes (1)

  • Time in Target Blood Glucose Range

    Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will assess the difference between the assessment and baseline phase for the intervention group. Target blood glucose range is 3.9 to 10.0mmol/l (70 to 180mg/dL)

    Day 1-15 compared with Day 60-74

Secondary Outcomes (2)

  • HbA1c

    Day 1 compared with Day 74

  • Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60.

    Day 60 compared to day 1

Study Arms (2)

Intervention

OTHER

Subjects will use a FreeStyle InsuLinx blood glucose meter during the study

Device: FreeStyle InsuLinx

Control

OTHER

Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.

Device: FreeStyle Freedom Lite

Interventions

FreeStyle InsuLinxDEVICE

FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.

Intervention
FreeStyle Freedom LiteDEVICE

FreeStyle Freedom Lite is a blood glucose meter

Control

Eligibility Criteria

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

You may qualify if:

  • Subject with Type 1 diabetes on MDI (3 or more insulin injections per day (U100 insulin)) for at least 1 year and insulin adjusting
  • HbA1c between 7.0% and 9.5% (53 to 80 mmol/mol) inclusive
  • Age 18 and over
  • In the investigator's opinion, thought technically capable of using masked CGM
  • Subject self reporting a minimum of 21 SMBG tests per week prior to study enrolment
  • Willing to perform a minimum of 4 SMBG tests per day during study

You may not qualify if:

  • Subject has any concomitant disease or condition that, in the investigator's opinion, may compromise patient safety
  • Subject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management
  • Subject is pregnant / planning to become pregnant within the planned study timeline
  • Subject is known to require a dose of more than 50 units of U100 insulin in any one bolus injection
  • Subject is currently on an insulin pump
  • Subject is currently using the FreeStyle InsuLinx
  • Subject is currently using the FreeStyle Freedom Lite
  • Subject is currently using CGM
  • Subject has an allergy to medical grade adhesives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Diabetes Zentrum Mergentheim

Bad Mergentheim, 97980, Germany

Location

Diabetes-Zentrum für Kinder und Jugendliche

Hanover, 30173, Germany

Location

Institut für Diabetes - Technology Forschungs - und Entwicklungsgesellschaft mbH an der Universität Ulm

Ulm, D-89081, Germany

Location

VU University Medical Centre (VUMC)

Amsterdam, 1007 MB, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Snr Director, Clinical Development & Regulatory Affairs
Organization
Abbott Diabetes Care
joe.bugler@abbott.com
01993 863164

Study Officials

  • Prof. Michaela Diamant

    VU University Medical Centre (VUMC)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2012

First Posted

January 27, 2012

Study Start

January 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

April 1, 2016

Results First Posted

April 1, 2016

Record last verified: 2016-03

Locations

NL(1)DE(3)