Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Effect on Glucose Control and Quality of Life for People With Type 2 Diabetes of Using a Device to Measure Glucose Levels at Home and Send Them to the Clinic, Rather Than Attending an Out-patient Clinic for Blood Tests
The aim of this study is to understand, in adult patients with Type 2 diabetes mellitus, if
the use of telemedicine (monitoring and treatment without patients having to attend a
healthcare facility) and home-based care is more effective than traditional general
practitioner (GP) and outpatient care in terms of patients taking medication regularly and
their quality of life.
The hypothesis of this study is that patients with Type 2 diabetes mellitus uploading data on
a telemedicine system achieve a glycemic control, evaluated in terms of glycated hemoglobin
levels, similar to that of patients followed in a traditional diabetes outpatient department,
with improvements to quality of life
Background and study aims Diabetes mellitus is a long-lasting disease in which the level of
blood sugar is higher than normal. High level of sugar in the blood can lead to serious
consequences, including blindness, kidney failure, amputation of limbs, coma and death.
Patients with diabetes need to regularly take their medicine and to make sure they monitor
the level of sugar in their blood on daily basis. This can affect their quality of life. The
aim of this study is to understand if telemedicine (monitoring and treatment without patients
having to attend a healthcare facility) and home-based care is more effective than
traditional GP and outpatient care in terms of patients taking medication regularly and their
quality of life.
Who can participate? Men and women who live in the study area, have been diagnosed with type
2 diabetes at least 1 year before the start of the study and have been on the same treatment
for at least 3 months.
What does the study involve? The participants will be recruited by GPs and doctors working in
diabetes centres. Participants will be randomly assigned to one of two groups. One group will
be treated and followed according as usual. They will test their blood sugar level at home
and record it on paper. They will attend a diabetes outpatient clinic for follow-up. The
other group will record the level of blood sugar using a digital home-based system that will
send data to the diabetes clinic for follow-up. All participants will receive treatment as
appropriate from the clinic. At the end of the study (after 18 months), the two groups will
be compared to assess which group achieved a better control of their blood sugar level and
which experienced a better quality of life, assessed using a questionnaire. The participants
will also have their height, weight, waist circumference, blood pressure, cholesterol and
blood fats measured at the beginning and end of the study.
What are the possible benefits and risks of participating? All patients will receive
medication as usual and the control group will continue to attend outpatient clinic, so there
are no additional risks associated with participating in the trial. The telemedicine group
might benefit from avoiding the inconvenience of having to attend outpatient clinics and from
a more rapid response to changes in their blood sugar level from the clinic.
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