Effect of Self-monitoring of Blood Glucose in Patients With Type 2 Diabetes Mellitus Not Using Insulin
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Purpose
Self-monitoring of blood glucose (SMBG) is one of the important instruments in diabetes management. Most patients with type 1 diabetes and patients with type 2 using insulin, frequently measure their blood glucose in case of possible hypoglycemia, but also to evaluate the insulin treatment and get information about how to change the insulin regimen, if necessary. Without SMBG it is almost impossible to achieve this goal.
The purpose of this study is to determine if self-monitoring in patients with type 2 diabetes not using insulin results in better glycemic control.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Behavioral: Self-monitoring of blood glucose (SMBG) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Self-monitoring of Blood Glucose in Patients With Type 2 Diabetes Mellitus Who Are Not Using Insulin. A Randomized Controlled Trial |
- Glycemic control; HbA1c at baseline, 3 months, 6 months, 9 months and 1 year (endpoint) [ Time Frame: baseline, 3 months, 6 months, 9 months and 1 year (endpoint) ] [ Designated as safety issue: No ]
- Quality of life; score on scale at baseline, 6 months and endpoint [ Time Frame: baseline, 6 months and endpoint ] [ Designated as safety issue: No ]
- Diabetes related complaints; score at baseline, 6 months and endpoint [ Time Frame: baseline, 6 months and endpoint ] [ Designated as safety issue: Yes ]
- Treatment satisfaction; score on scale at baseline, 6 months and endpoint [ Time Frame: baseline, 6 months and endpoint ] [ Designated as safety issue: No ]
- Incidence of (necessity to start) insulin therapy; at endpoint [ Time Frame: anywhere during the study ] [ Designated as safety issue: No ]
- dosage of oral blood glucose lowering drugs; at baseline, 6 months and endpoint [ Time Frame: baseline, 6 months and endpoint ] [ Designated as safety issue: No ]
- bodyweight; Bodymass index at baseline and endpoint [ Time Frame: baseline and endpoint ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2006 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
-
Behavioral: Self-monitoring of blood glucose (SMBG)
Study Objectives:
Primary: What is the effect of SMBG in patients with type 2 diabetes who are not using insulin on Glycemic control (as measured with glycosylated hemoglobin (HbA1c)?
Secondary: What is the effect of SMBG in patients with type 2 diabetes who are not using insulin on the following parameters:
- Health status
- Diabetes related complaints
- Patient satisfaction
- Cumulative incidence of (necessity to start) insulin therapy / maximum dosage of oral blood glucose lowering drugs
- Dosage of oral blood glucose lowering drugs
- Bodyweight (BMI)
Two treatment protocols are proposed. Treatment A consists of self-monitoring of blood glucose and treatment B consists of usual care. Patients in the A-group are instructed to measure their blood glucose values 4 times a day (1 fasting plasma glucose concentration and 3 post-meal glucose concentrations), two times a week, on one week day, and one weekend day (no more, no less). Patients should record these glucose values in a diary. Patient will get one page with information in Dutch. No further education than for handling the device and interpreting the values is given, so that besides this intervention, there will be no differences compared with the control group like other forms of education.
The duration fo the trial will be 12 months.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Type 2 diabetes
- HbA1c 7 - 8,5% at previous and present annual check-up
- Use of 1 or 2 different oral blood glucose lowering drugs
- In case of two oral blood glucose lowering drugs, they should not both have a maximum dosage
- Sufficient knowledge of the Dutch language to understand the requirements for the study
Exclusion criteria:
- Change in oral blood glucose lowering drugs in the past three months
- Use of insulin
- Use of device for self-monitoring of blood glucose at the start of the study, or in the preceding 6 months
Contacts and Locations| Netherlands | |
| Isala Clinics | |
| Zwolle, Netherlands, 8000 GM | |
| Principal Investigator: | Henk J Bilo, MD; PhD | Isala Clinics, medical research foundation |
More Information
No publications provided
| Responsible Party: | Nanne Kleefstra, MD PhD, Medical Research Foundation, The Netherlands |
| ClinicalTrials.gov Identifier: | NCT00287807 History of Changes |
| Other Study ID Numbers: | IC-06-02-SL |
| Study First Received: | January 30, 2006 |
| Last Updated: | September 23, 2011 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Medical Research Foundation, The Netherlands:
|
Diabetes mellitus, type 2 Blood Glucose Self-Monitoring life style |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013