Blood Glucose Self Monitoring and HbA1c Effects on Glucose Control

• a representative blood glucose profile (self monitoring) during the week before the end of the trial [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• body weight at the end of the trial [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• serum, triglycerides and cholesterol (total HDL as well as LDL-cholesterol) at the end of the trial [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• therapy-satisfaction (questionnaire) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• changes of the antidiabetic therapy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• number of hospitalization as a result of hypoglycaemic episodes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• the number of serious hypoglycaemic episodes (hypoglycaemic episodes when the patient needs help from other people) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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.

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:

1. no regular blood-glucose self-monitoring, no regular HbA1c
2. regular blood glucose self monitoring, no regular HbA1c
3. no regular blood glucose self monitoring, regular HbA1c
4. 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.

• Procedure: weekly blood glucose profile
  once daily self-control of urinary-glucose
• Procedure: three-monthly haemoglobin A1c
  once daily self-control of urinary-glucose
• Procedure: no blood-glucose self-control
  once daily self-control of urinary-glucose

• Experimental: 1
  No blood-glucose self-control, no HbA1c
  Intervention: Procedure: no blood-glucose self-control
• Experimental: 2
  Blood-glucose self-control, no HbA1c
  Intervention: Procedure: weekly blood glucose profile
• Experimental: 3
  No blood-glucose self-control, HbA1c
  Interventions:

  • Procedure: three-monthly haemoglobin A1c
  • Procedure: no blood-glucose self-control
• Experimental: 4
  Blood-glucose self-control, HbA1c
  Interventions:

  • Procedure: weekly blood glucose profile
  • Procedure: three-monthly haemoglobin A1c

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 )