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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Medical Research Foundation, The Netherlands.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier:
NCT01460459
First received: October 19, 2011
Last updated: October 24, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Behavioral: a specific frequency of SMBG

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Self-monitoring of Blood Glucose in Insulin-treated Patients With Type 2 Diabetes: a 9-month Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Medical Research Foundation, The Netherlands:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • quality of life [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: May 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01460459

Contacts
Contact: Johanna Hortensius, RN 0031-38-4247763 h.hortensius@isala.nl
Contact: Nanne Kleefstra, MD PhD 0031-38-4244013 n.kleefstra@isala.nl

Locations
Netherlands
Diabetes Centre, Isala Clinics Recruiting
Zwolle, Netherlands, 8025 BT
Principal Investigator: Henk JG Bilo, MD PhD FCRP         
Sponsors and Collaborators
Medical Research Foundation, The Netherlands
Sanofi
Investigators
Principal Investigator: Henk JG Bilo, MD PhD FCRP Isala Klinieken
  More Information

No publications provided

Responsible Party: Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier: NCT01460459     History of Changes
Other Study ID Numbers: 35308.075.11
Study First Received: October 19, 2011
Last Updated: October 24, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Medical Research Foundation, The Netherlands:
diabetes
self-monitoring of blood glucose
frequency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 23, 2014