Comparison Study of Blood Glucose Monitoring Systems in P... | NCT01234727

Studies
Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes

NCT01234727

Sponsor

Abbott Diabetes Care

Status

Completed

Last Update Posted

Mar 23, 2026Actual

Enrollment

501Actual

Phase

Not provided

Conditions

Diabetes Mellitus

Interventions

Not provided

Countries

Germany
Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Nov 3, 2010

First Submission Date that Met QC Criteria

Nov 3, 2010

First Posted Date

Nov 4, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2026

Last Update Posted Date

Mar 23, 2026Actual

Name	Class
ikfe-CRO GmbH	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

501Actual

Label	Type	Description	Intervention Names
Diabetes		Patients with Type 1 or Type 2 diabetes requiring insulin.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects diagnosed with type 1 or type 2 diabetes mellitus
Age between 18 and 75 years.
Patients with stable blood glucose in judgment of the investigator.
Subjects receive intensive insulin therapy (Multiple Daily Injection defined as at least two insulin injections per day)
Patients perform blood glucose self measurements on a routine basis
Patients must have experience in self measurement blood glucose for at least 6 months.

Exclusion Criteria:

Patients with unstable blood glucose in judgment of the investigator.
Patient has been diagnosed with progressive / serious diseases that in judgment of the investigator preclude successful completion of the observational period.
Lack of compliance or other justifications that, in the discretion of the investigator, precludes satisfactory participation in the study.
Subject without legal capacity.
Blood donation within the last 30 days.
Known pregnancy.
Subject has already participated in the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Up to 480 subjects with type 1 or 2 diabetes mellitus

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joe Bugler	Abbott Diabetes Care	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zentrum für Diabetes und Gefäßerkrankungen		Münster		48145	Germany
Diabetes Zentrum Neuwied

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22176154	Result	Tack C, Pohlmeier H, Behnke T, Schmid V, Grenningloh M, Forst T, Pfutzner A. Accuracy evaluation of five blood glucose monitoring systems obtained from the pharmacy: a European multicenter study with 453 subjects. Diabetes Technol Ther. 2012 Apr;14(4):330-7. doi: 10.1089/dia.2011.0170. Epub 2011 Dec 16.

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases