We aim to describe and identify distinct daily glucose patters (DGP) in the general population that are related to increased risk of diabetes and diabetes related micro- and macro-vascular complications using the flash sensor technology through the…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Glucose metabolism disorders (incl diabetes mellitus)
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Average glucose levels per 24-hours, per week, over the investigation period,
nocturnal, before breakfast.
- Time in range, time above range (high, very high), Time below range.
- Peak glucose levels, peak post-prandial glucose levels, time to peak in
relation to dietary pattern
- Average area under the curve.
- Incidence of prediabetes and diabetes
- Incidence of micro- and macrovascular events (including kidney function
cardiovascular disease and stroke amongst others).
Secondary outcome
NA
Background summary
Diagnostic criteria for both prediabetes and T2D rely mostly on fasting or
past-prandial glucose levels, with a confirmatory test. However, technological
advances, such as flash glucose monitoring and continuous real time glucose
sensors have now made it possible to asses extensive daily glucose patterns.
There is currently no to little information on how characteristics in these
daily glucose patterns relate to the risk of progressing to T2D and its long
term complications. This information may provide a plethora of insights to
differences between high risk individuals and why some do and some do not show
disease progression. This field of research can provide new pathophysiological
insights that could ultimately lead to new and improved diagnostic tools and
preventive strategies.
Study objective
We aim to describe and identify distinct daily glucose patters (DGP) in the
general population that are related to increased risk of diabetes and diabetes
related micro- and macro-vascular complications using the flash sensor
technology through the Free Style Libre (FSL).
Study design
Observational study in the general population. We will apply the FSL (blinded
sensor) to participants from the Rotterdam Study for two weeks.
Study burden and risks
The application of the FSL will be performed during a regular visit at the
research center of the Rotterdam Study by one of the research physicians. The
risks of physical harm are negligible but include bruising and local allergic
reaction to the patch. We will ask participants to return the sensor either in
person or by postal service depending on the preference of the participant and
whether another visit is already planned in the context of the Rotterdam Study.
Contraindications include imaging through MRI, CT-scan or röntgen or a
diathermia treatment. The participants will not get any other physical or
dietary restrictions and are allowed to perform their daily activities
including water activities such as showering and swimming.
Dr. Molewaterplein 50
Rotterdam 3015 GE
NL
Dr. Molewaterplein 50
Rotterdam 3015 GE
NL
Listed location countries
Age
Inclusion criteria
Adult participants of the Rotterdam Study (a population based cohort) that
provide informed consent to participate.
Exclusion criteria
Insulin therapy requiring diabetes
Design
Recruitment
Medical products/devices used
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 | NL81467.078.22 |