The purpose of this observational pilot study is to evaluate the extent to which the combined glucose, heart rate, blood pressure, and other outcome patterns, collected from wearables, are associated with the severity of micro- and macrovascular…
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure of this study is the degree of correlation between
the parameter patterns, measured by the wearable, and the severity of the
micro- and macrovascular damage, as determined by the conventional analyses.
Secondary outcome
not applicable
Background summary
Chronic lifestyle-related diseases put an increasing burden on patients and
healthcare. Taking type 2 diabetes (T2D) as an example, there are around 1M
patients in the Netherlands. T2D is linked to poor quality of life and
associated with a healthcare expenditure of 6B euros/yr. Diabetes is defined by
glycemic dysregulation, with 40-56% suffering from micro- and macrovascular
complications or co-morbidities. Microvascular complications include diabetic
retinopathy, nephropathy and neuropathy because of impaired oxygen supply to
the tissues. Macrovascular complications lead to heart failure, stroke and
other cardiovascular complications. Co-morbidities include depression, diabetes
distress and impaired psychological wellbeing in general. Especially micro- and
macrovascular complications have been identified by people with diabetes as
meaningful outcomes. Standardized outcome measures, captured by questionnaires,
clinical observation, and clinical chemistry are an important driver of the
transition towards value-based healthcare beyond managing HbA1c numbers to
prevent complications and comorbidities that matter to the patient. Yet, these
measures are burdensome and hamper the implementation of meaningful patient
outcome measures. By applying non-invasive measurements with wearables, this
burden could be greatly reduced and these obstacles could be removed.
Study objective
The purpose of this observational pilot study is to evaluate the extent to
which the combined glucose, heart rate, blood pressure, and other outcome
patterns, collected from wearables, are associated with the severity of micro-
and macrovascular complications. The results of this study can be used to
determine whether these digital biomarkers can be used to assess the severity
of these complications in a non-intrusive and non-invasive way.
Study design
This is an observational study in which physiological parameters are measured
using wearables during a normal lifestyle over a period of ten days.
Study burden and risks
The subjects will have minimal burden in the form of a one-time blood draw to
determine several diabetes and CVRM parameters.
Blood sampling is normally well tolerated by patients.
In addition, the subject must wear two CGM systems on the upper arm for 10
days, as well as a digital wristband.
Adverse consequences of this are nil.
The subject will also undergo a non-invasive fundoscopy and Pulse wave velocity
measurement. In practice, this never causes any problems for those who undergo
these tests.
The subject does not have to make any adjustments to the usual lifestyle, which
therefore does not entail any additional risks
The risks of adverse effects when participating in this study are considered
negligible.
Reinier de Graafweg 7
Delft 2625AD
NL
Reinier de Graafweg 7
Delft 2625AD
NL
Listed location countries
Age
Inclusion criteria
- Prediabetic or diagnosed with diabetes type 2;
- BMI in the range of 25-35 kg/m2
- Aged in the range of 40 - 65 years
- Normal physical activity patterns
- Able and willing to sign the informed consent form
- Willing to comply with all study procedures
Exclusion criteria
- Type 1 diabetes
- Kidney diseases other than related to diabetes
- Cardiovascular diseases other than diabetes and/or hypertension related
- Skin allergy, eczema or known sensitivity for adhesives
Design
Recruitment
metc-ldd@lumc.nl
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 | NL87338.058.24 |