diabetes
Conditions
Interventions
The patient has to measure his/her fasting glucose value with the glucose meter
on a daily basis. After three days patients have to enter their fasting plasma
glucose values in the PANDIT system, co
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Male or female between 18 and 80 years * Type 2 diabetes mellitus * Using once daily basal Insulin therapy or requiring once daily basal insulin * Fasting glucose * 7 mmol / l on 3 consecutive measurements, no restriction on HbA1c * BMI
Exclusion criteria
Exclusion criteria: *Type 1 diabetes *Non compliance with regard to daily measurement of FPG *Recurrent severe hypoglycaemia or hypoglycaemic unawareness *Active proliferative diabetic retinopathy *Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which could interfere with the results of the trial *Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study *History of alcohol abuse *Night shift workers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Dosing advices given by the DN (phase 1) *Dosing advices generated by the PANDIT system (phase 1) *Dosing advices generated by the PANDIT system that are declined by the DN (phase 2) *Episodes of hypoglycaemia | — |
Secondary
| Measure | Time frame |
|---|---|
| *Usability evaluation *The amount of patients visiting the PANDIT® system at least every week *The number of unscheduled contact moments with the DN because of medical questions *The number of unscheduled contact moments with the DN because of technical questions *Self monitored blood glucose values *Used daily insulin doses *Laboratory fasting plasma glucose *HbA1c *Adverse events *Serious adverse events | — |
Countries
Netherlands
Outcome results
None listed