Self-monitoring of Blood Glucose in Insulin-treated Patients With Type 2 Diabetes
1 other identifier
interventional
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started May 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 19, 2011
CompletedFirst Posted
Study publicly available on registry
October 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedOctober 26, 2011
October 1, 2011
7 months
October 19, 2011
October 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c
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 Outcomes (1)
quality of life
9 months
Study Arms (3)
high frequency of SMBG
EXPERIMENTALPatients are instructed to measure their blood glucose concentrations 4 times per day (pre-prandial and before bedtime) one day weekly in group A.
middle frequency of SMBG
EXPERIMENTALPatients 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.
low frequency of SMBG
EXPERIMENTALPatients are instructed to measure their blood glucose concentrations 4 times per day (pre-prandial and before bedtime) Group C: one day monthly
Interventions
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
You may qualify if:
- 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.-
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical Research Foundation, The Netherlandslead
- Sanoficollaborator
Study Sites (1)
Diabetes Centre, Isala Clinics
Zwolle, 8025 BT, Netherlands
Related Publications (1)
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.
PMID: 29334997DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henk JG Bilo, MD PhD FCRP
Isala
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2011
First Posted
October 26, 2011
Study Start
May 1, 2011
Primary Completion
December 1, 2011
Study Completion
July 1, 2012
Last Updated
October 26, 2011
Record last verified: 2011-10