The primary objective of this study is to assess the effects on glycaemic control of self adjusting insulin in patients with suboptimal controlled type 2 diabetes starting on insulin, with internet support and strict schedules. In addition, effects…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference between intervention and usual care groups in glycaemic control
measured by change in glycated haemoglobin concentration (HbA1c)
Secondary outcome
*Treatment satisfaction
*Quality of life
*Self-efficacy beliefs
*Illness perceptions
*Number of hypoglycaemias
Background summary
A great part of the patients still doesn*t reach the optimal glycaemic target
level. High glycaemia is associated with a higher risk to develop severe
complications. One of the obstacles in the disease management is the transition
to insulin therapy. Patient empowerment, an approach aiming for a more central
position of the patient, in which he/she takes more responsibility on his/her
disease, seems to be an important basis to improve diabetes care. Making use
of interactive technologies, such an environment is created, in which the
patient can manage his/her treatment him/herself, including insulin titration
and self-adjustment. The internet programme functions as a facilitating and
supporting tool, where patients can monitor their glucose levels and where
feedback and advice will be given, guided by the self-regulation theory of
Leventhal.
Study objective
The primary objective of this study is to assess the effects on glycaemic
control of self adjusting insulin in patients with suboptimal controlled type 2
diabetes starting on insulin, with internet support and strict schedules. In
addition, effects on quality of life, treatment satisfaction and number of
hypoglycaemias will be studied.
Study design
Open, parallel, randomized, controlled trial in patients with type 2 diabetes
from general practices.
Intervention
The intervention group will titrate insulin by themselves, assisted by an
internet program based on fasting glucose measures. De control group will be
treated as usual: the health care provider will adjust the insulin dose. The
total duration of the study is 12 months. Together with the inclusion period of
12 months, the study time will take 24 months. Measures will be taken at
baseline and after 3, 6 and 12 months.
Study burden and risks
When using medication, there will be some risk to get an adverse event. Adverse
reactions of insulin glargine (Lantus) are: hypoglycaemia, sometimes (0,1-1%)
urticaria, rash.
When patients join the study, the intervention group will have to use the
internet program for 1 year and both groups have to fill in questionnaires for
4 times on the internet.
Van der Boechorststraat 7
1081 BT
NL
Van der Boechorststraat 7
1081 BT
NL
Listed location countries
Age
Inclusion criteria
Diabetes type 2
HbA1c > 7.0% with maximum oral glucose lowering drugs
age between 35 and 75 years
can make use of and access to the internet
Exclusion criteria
Serious mental impairment
Serious endocrine disorders
Serious disease with a life expectancy < 1 year
corticosteroid use
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL22941.029.08 |
| Other | TC1316 |