Effect of Self-monitoring of Blood Glucose in Patients Wi... | NCT00287807

Studies
Effect of Self-monitoring of Blood Glucose in Patients With Type 2 Diabetes Mellitus Not Using Insulin

NCT00287807

Sponsor

Medical Research Foundation, The Netherlands

Status

Completed

Last Update Posted

Sep 26, 2011Estimated

Enrollment

60Estimated

Phase

Phase 3

Conditions

Diabetes Mellitus, Type 2

Interventions

Self-monitoring of blood glucose (SMBG)

Countries

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

Sep 2011

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

Feb 2006

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Jan 30, 2006

First Submission Date that Met QC Criteria

Feb 6, 2006

First Posted Date

Feb 7, 2006Estimated

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

Sep 23, 2011

Last Update Posted Date

Sep 26, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nanne Kleefstra, MD PhD, Medical Research Foundation, The NetherlandsPrincipal Investigator

Lead Sponsor

Medical Research Foundation, The NetherlandsOTHER

Collaborators

Name	Class
Langerhans Foundation, the Netherlands	OTHER

Description Module

Brief Summary

Self-monitoring of blood glucose (SMBG) is one of the important instruments in diabetes management. Most patients with type 1 diabetes and patients with type 2 using insulin, frequently measure their blood glucose in case of possible hypoglycemia, but also to evaluate the insulin treatment and get information about how to change the insulin regimen, if necessary. Without SMBG it is almost impossible to achieve this goal.

The purpose of this study is to determine if self-monitoring in patients with type 2 diabetes not using insulin results in better glycemic control.

Detailed Description

Study Objectives:

Primary: What is the effect of SMBG in patients with type 2 diabetes who are not using insulin on Glycemic control (as measured with glycosylated hemoglobin (HbA1c)?

Secondary: What is the effect of SMBG in patients with type 2 diabetes who are not using insulin on the following parameters:

Health status
Diabetes related complaints
Patient satisfaction
Cumulative incidence of (necessity to start) insulin therapy / maximum dosage of oral blood glucose lowering drugs
Dosage of oral blood glucose lowering drugs
Bodyweight (BMI)

Two treatment protocols are proposed. Treatment A consists of self-monitoring of blood glucose and treatment B consists of usual care. Patients in the A-group are instructed to measure their blood glucose values 4 times a day (1 fasting plasma glucose concentration and 3 post-meal glucose concentrations), two times a week, on one week day, and one weekend day (no more, no less). Patients should record these glucose values in a diary. Patient will get one page with information in Dutch. No further education than for handling the device and interpreting the values is given, so that besides this intervention, there will be no differences compared with the control group like other forms of education.

The duration fo the trial will be 12 months.

Design Module

Study Type

Interventional

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Self-monitoring of blood glucose (SMBG)	Behavioral	2 times a week (one in weekend and one during week) self measurement of blood glucose: fasting and three times post prandial

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glycemic control; HbA1c at baseline, 3 months, 6 months, 9 months and 1 year (endpoint)		baseline, 3 months, 6 months, 9 months and 1 year (endpoint)

Secondary Outcomes

Measure	Description	Time Frame
Quality of life; score on scale at baseline, 6 months and endpoint		baseline, 6 months and endpoint
Diabetes related complaints; score at baseline, 6 months and endpoint		baseline, 6 months and endpoint

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Type 2 diabetes
HbA1c 7 - 8,5% at previous and present annual check-up
Use of 1 or 2 different oral blood glucose lowering drugs
In case of two oral blood glucose lowering drugs, they should not both have a maximum dosage
Sufficient knowledge of the Dutch language to understand the requirements for the study

Exclusion criteria:

Change in oral blood glucose lowering drugs in the past three months
Use of insulin
Use of device for self-monitoring of blood glucose at the start of the study, or in the preceding 6 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henk J Bilo, MD; PhD	Isala Clinics, medical research foundation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Isala Clinics		Zwolle		8000 GM	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015190	Blood Glucose Self-Monitoring

Ancestor Terms

ID	Term
D001774	Blood Chemical Analysis
D019963	Clinical Chemistry Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided