Self-monitoring of Blood Glucose in Insulin-treated Patients With Type 2 Diabetes: a 9-month Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- HbA1c
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- quality of life(9 months)