Self-monitoring of Blood Glucose in Insulin-treated Patients With Type 2 Diabetes
NCT ID: NCT01460459
Last Updated: 2011-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
150 participants
INTERVENTIONAL
2011-05-31
2012-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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
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.
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
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
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* \> 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Medical Research Foundation, The Netherlands
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Henk JG Bilo, MD PhD FCRP
Role: PRINCIPAL_INVESTIGATOR
Isala
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Diabetes Centre, Isala Clinics
Zwolle, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Hortensius J, Kleefstra N, Landman GWD, Houweling BT, Groenier KH, van der Bijl JJ, Bilo H. Effects of three frequencies of self-monitored blood glucose on HbA1c and quality of life in patients with type 2 diabetes with once daily insulin and stable control: a randomized trial. BMC Res Notes. 2018 Jan 15;11(1):26. doi: 10.1186/s13104-018-3138-7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
35308.075.11
Identifier Type: -
Identifier Source: org_study_id