Blood Glucose Self Monitoring and HbA1c Effects on Glucose Control

Study Overview
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Brief Summary
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The purpose of this randomized, prospective trial is to determine wether (a) a once weekly glucose profile (self monitoring) or (b) a three-monthly report of the actual glycated haemoglobin are effective interventions to improve HbA1c after one year in typ 2-diabetic patients on conventional insulin treatment.

Detailed Description
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The design is an open, prospective, randomised, multicentre parallel group study. The total duration will be 5 years with patient recruitment over 4 years and an individual observation period of 1 year. 300 participants from 43 study centres, hospitals and private practices were recruited. The study will run for one year and aims to determine, whether there is an advantage with regard to HbA1c levels when (a) a regular three-monthly HbA1c or (b) a weekly 4-point glucose profile is taken and reported. After screening, patients will be assigned at random to one of the following study arms: no regular blood-glucose self-monitoring, no regular HbA1c regular blood glucose self monitoring, no regular HbA1c no regular blood glucose self monitoring, regular HbA1c regular blood glucose self monitoring, regular HbA1c The control for all participants is that urinary glucose should be monitored at least once a day, preferably in the late morning, as the highest increase in plasma glucose level occurs after breakfast.

Official Title
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The Benefit of the Blood Glucose Self Monitoring and a Regular Three-monthly Hemoglobin A1c Profile in Patients With Type 2-diabetes and Conventional Insulin Therapy

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Procedure: weekly blood glucose profile
* Procedure: three-monthly haemoglobin A1c
* Procedure: no blood-glucose self-control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2-diabetes (ADA/WHO-Criteria) Conventional insulin therapy ( 1-3 daily injections of basal- and/or mixed insulin also in combination with oral agents.) Age:> 40 years BMI:> 20 kg/m² Exclusion Criteria: Impaired liver function, defined as > 2 times upper limit of normal Impaired renal function defined liver enzymes as serum-creatinine > 1.3 mg/dl Gastro-intestinal diseases (disturbances, diagnoses) Inability to perform study-related activities according to the present protocol Pregnancy not certainly excluded Abuse of alcohol and/or other drugs Participation in other clinical trials during the past 3 month Threat to general state of health Intensified insulin therapy (at least 3 times rapid-acting insulin) Frequent blood glucose self monitoring during the past 3 months (more than one 4-point glucose profile per week or more than one blood glucose/ urinary glucose test per day )

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>No blood-glucose self-control, no HbA1c | Procedure: no blood-glucose self-control<br>* once daily self-control of urinary-glucose<br>|
| Experimental: 2<br>Blood-glucose self-control, no HbA1c | Procedure: weekly blood glucose profile<br>* once daily self-control of urinary-glucose<br>|
| Experimental: 3<br>No blood-glucose self-control, HbA1c | Procedure: three-monthly haemoglobin A1c<br>* once daily self-control of urinary-glucose<br>Procedure: no blood-glucose self-control<br>* once daily self-control of urinary-glucose<br>|
| Experimental: 4<br>Blood-glucose self-control, HbA1c | Procedure: weekly blood glucose profile<br>* once daily self-control of urinary-glucose<br>Procedure: three-monthly haemoglobin A1c<br>* once daily self-control of urinary-glucose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin A1c after one year |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a representative blood glucose profile (self monitoring) during the week before the end of the trial |  | 1 year | 
| body weight at the end of the trial |  | 1 year | 
| serum, triglycerides and cholesterol (total HDL as well as LDL-cholesterol) at the end of the trial |  | 1 year | 
| therapy-satisfaction (questionnaire) |  | 1 year | 
| changes of the antidiabetic therapy |  | 1 year | 
| number of hospitalization as a result of hypoglycaemic episodes |  | 1 year | 
| the number of serious hypoglycaemic episodes (hypoglycaemic episodes when the patient needs help from other people) |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes control, glycated haemoglobin, blood-glucose-self-monitoring, type 2-diabetes, conventional insulin therapy