Web-based insulin titration: Improving diabetes care in the Netherlands. An efficacy study.

Diabetes mellitus is a disease characterized by an absolute or relative deficit
of insulin, a hormone necessary for the uptake of glucose into the cells. As a
consequence, the blood glucose levels of patients with diabetes are high,
leading not only to acute complaints such as thirst and fatigue, but also to
serious long term complications such as blindness, kidney failure and
cardiovascular disease. The occurrence of these long term complications can be
significantly reduced by adequate treatment, aiming for a reduction of blood
glucose levels to non diabetic values by diet, oral anti-diabetic treatment or
insulin therapy. The effect of this treatment is evaluated by the widely
accepted marker HbA1c (glycosylated haemoglobin), which reflects the average
blood glucose level over a period of six to eight weeks. Current guidelines
recommend an HbA1c goal of 7% or lower, which has been shown to result in a
significant reduction of diabetes related morbidity and mortality. This,
however, has proven to be an elusive goal, the average HbA1c level in the
Netherlands being 7.6% for type 2 diabetes patients and 7.8% in type 1 diabetes
patients. A new strategy to achieve the appropriate HbA1c value in these
patients is urgently needed, as none of the novel pharmacotherapeutic options
can be expected to deliver such a result. Insulin therapy is still the most
potent agent in the therapeutic arsenal, being cost-effective and without an
upper dose limit. However, treating patients with insulin requires active dose
titration, increasing or decreasing the insulin dose according to blood glucose
response, diet, physical activity and the occurrence of possible side effects
such as hypoglycaemia (low blood glucose). The average 3-4 clinical visits per
year fail to provide sufficient titration opportunities and may cause the
treating physician or nurse to be cautious with dose increments, thus not
reaching the treatment*s full potential and HbA1c levels below 7%. Therefore,
we propose to develop an online, computerized titration algorithm to guide
patients in self-titration, the PANDIT system (Patient Assisting Net-based
Diabetes Insulin Titration). The use of an online, insulin titration algorithm
will not only allow for intensive treatment of patients with diabetes but also
shifts the focus of their treatment to self-management. The Diabetes Research
Group and Clinical Informatics Division of the Academic Medical Center will
develop the program that gives advice on insulin doses. An algorithm for
adjusting insuline doses that has already been proven to be effective will be
used. Patients are given a unique account and password to the website. The
Pandit be developed for patients with diabetes mellitus type 2, using once
daily insulin injections.

The main objective of the present study is to determine whether an intensive
internet based titration system is effective in improving glycemic control in
patient with diabetes mellitus type 2 using a basal insulin, compared to
standard care.

This will be an open multi-center randomized controlled trial. Patients will be
randomized to receive either 26 weeks of standard care (control group) or care
via an intensive internet based titration system (PANDIT, intervention group).

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 hypoglycemia. Based on those data the
PANDIT system will immediately provide an insulin dosing advice for the
patient. The control group will receive usual care.

Participation mainly requires daily blood glucose measurements and daily use of
a computer program on the Internet. PANDIT titration will be performed at home
with intervals of 3-7 days. Participants will be asked to fill in several
questionnaires, and to visit their caregiver at the beginning, halfway and at
the end of the study. During visits, a venapuncture will be performed.
The most important benefit for the patient is a possible improvement in
glycemic control through this system. Furthermore, PANDIT supports and reminds
the patient to measure and document their fasting glucose values. This will
raise more awareness among patients and thereby motivates the patient to
actively participate in the management of their disease. In addition, receiving
insulin dosing advice from and through an online application (telemedicine
functionalities also enable direct contact with the caregiver) spares them the
need to travel to the clinic.