Self-monitoring of Blood Glucose in Insulin-treated Patients With Type 2 Diabetes

October 24, 2011 updated by: Medical Research Foundation, The Netherlands

Self-monitoring of Blood Glucose in Insulin-treated Patients With Type 2 Diabetes: a 9-month Randomised Controlled Trial

Primary Objective:

The objective of the study is to investigate the effect of a specific frequency of Self-monitoring of blood glucose (SMBG) on glycemic control and quality of life in patients with type 2 diabetes and who are in stable good glycemic control and using 1 insulin injection daily.

The research question is:

Does a less intensive frequency of SMBG in insulin-treated patients with type 2 diabetes, who are in stable good glycemic control, using 1 insulin injection daily, lead to a clinically relevant increase of HbA1c (an increase of 0.5%) and what is the effect on quality of life?

Secondary objectives:

The secondary objectives is to investigate the effect of a specific frequency of SMBG on the number of hypo and hyper glycaemia, number of extra diabetes-related contacts with the health care provider, and the diabetes medication.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

SUMMARY

Rationale:

Self-monitoring of blood glucose (SMBG) is an important tool in diabetes care to achieve and maintain good glycemic control. But how often 'should' the patient measure the capillary glucose concentration? There is no general agreement between professionals, and there is no evidence for a specific frequency and timing.

Objective:

The objective of the study is to investigate the effect of a specific frequency of SMBG on glycemic control and quality of life in patients with type 2 diabetes and who are in stable good glycemic control and using 1 insulin injection daily.

Study design:

An open Randomised Controlled Trial.

Study population:

Patients with insulin-treated diabetes type 2, > 18 years of age, using 1 insulin injection daily, performing SMBG > 1 year, HbA1c ≤ 58 mmol/mol (< 7.5%) in the preceding 12 months, sufficient knowledge of the Dutch language, no hypo-unawareness, no serious co-morbidity

Intervention:

Patients are instructed to measure their blood glucose concentrations 4 times per day (pre-prandial and before bedtime) one day weekly in group A, one day per two weeks in group B and one day monthly in group C. Patients are asked to keep a diary with the readings and the probably extra measurements, including the reasons.

Main study parameters/endpoints:

The main study parameters are glycemic control and quality of life. A difference of > 0.5% (> 5.5 mmol/mol) in HbA1c is considered to be relevant. Quality of life is measured with 3 validated questionnaires.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Patients in this study are used to perform SMBG. During the study, they are asked to monitor their glucose concentrations in a controlled, specific frequency (different kind of usual care are compared). And they are asked to fill in 3 questionnaires in the beginning and at the end of the study. Extra HbA1c measurements can be necessary. No side effects are expected, but safety is incorporated through HbA1c measurements every 3 months and every 3 months the diary will be discussed in the scheduled visits. Furthermore, extra measurements are allowed when necessary.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
      • Zwolle, Netherlands, 8025 BT
        • Recruiting
        • Diabetes centre, isala clinics
        • Principal Investigator:
          • Henk JG Bilo, MD PhD FCRP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with insulin-treated diabetes type 2
  • > 18 years of age
  • using 1 insulin injection daily,
  • performing SMBG > 1 year
  • HbA1c ≤ 58 mmol/mol (< 7.5%) in the preceding 12 months
  • sufficient knowledge of the Dutch language.-

Exclusion Criteria:

  • no hypo-unawareness
  • no serious co-morbidity (as judged by their own GP)
  • patients who measure their blood glucose concentration (4 measurements a day) more than once a week on average

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: high frequency of SMBG
Patients are instructed to measure their blood glucose concentrations 4 times per day (pre-prandial and before bedtime) one day weekly in group A.
Behavioral: a specific frequency of SMBG

Patients are instructed to measure their blood glucose concentrations 4 times per day (pre-prandial and before bedtime:

high frequency: one day weekly middle frequency:one day per two weeks low frequency:one day monthly
Experimental: middle frequency of SMBG
Patients are instructed to measure their blood glucose concentrations 4 times per day (pre-prandial and before bedtime) one day per two weeks in group B.
Behavioral: a specific frequency of SMBG

Patients are instructed to measure their blood glucose concentrations 4 times per day (pre-prandial and before bedtime:

high frequency: one day weekly middle frequency:one day per two weeks low frequency:one day monthly
Experimental: low frequency of SMBG
Patients are instructed to measure their blood glucose concentrations 4 times per day (pre-prandial and before bedtime) Group C: one day monthly
Behavioral: a specific frequency of SMBG

Patients are instructed to measure their blood glucose concentrations 4 times per day (pre-prandial and before bedtime:

high frequency: one day weekly middle frequency:one day per two weeks low frequency:one day monthly

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 9 months
The main study parameter is glycemic control. Glycemic control is measured by HbA1c. A difference of 0.5% (> 5.5 mmol/mol) in HbA1c between groups is considered to be relevant.
9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
quality of life
Time Frame: 9 months
The secondary study parameter is quality of life. The quality of life is measured by 3 validated questionnaires: the 12-item Short Form Health Survey, the 20-item Problems Areas in Diabetes Scale (PAID) and the 13-item Summary of Diabetes Self care Activities. Furthermore, the glucose concentrations measured by SMBG should be between 4-7 mmol/l, preprandial and between 8-10 mmol/l before bed time. The endpoint is the number of glucose concentrations who are out of range at every 4th week.The number of hypo and hyperglycaemia are reported in the diary.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical Research Foundation, The Netherlands

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sanofi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Henk JG Bilo, MD PhD FCRP, Isala

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2011

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 35308.075.11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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