diabetes
Conditions
Interventions
The intervention group needs to access the PANDIT site once every three days,
to enter their fasting glucose values from the last three days, their insulin
dosages and whether they experienced hypog
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 (diagnosed clinically) for >= 6 months •HbA1c >7.5% •Once daily basal insulin therapy usage of = 7 mmol/L on three consecutive measurements •BMI
Exclusion criteria
Exclusion criteria: •Type 1 diabetes •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 in the Investigator*s opinion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •To measure the mean changes in HbA1c from baseline to end point in the PANDIT group as compared to the control group. A difference of 0.5% after 26 weeks of follow-up in the PANDIT group as compared to the control group will be considered effective. HbA1c will be measured at baseline, after 13 weeks and after 26 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| •To evaluate the effect of PANDIT on the patient*s quality of life compared to standard care, as measured by the SF-36 quality of life questionnaire and the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at baseline, after 13 weeks and after 26 weeks of treatment •To measure the total contact time with the PANDIT system and study staff in the PANDIT group as compared to the contact time with the study staff in the control group •To measure the proportion of subjects who reach the target of HbA1c | — |
Countries
Netherlands
Outcome results
None listed