To establish the performance of the idi-CGM system among persons with DM.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the accuracy of the idi-CGM
compared to Contour Plus Blue strip capillary measurement results during the
14-day study period.
Secondary outcome
Secondary outcomes include (i) accuracy of the idi-CGM compared to the Dexcom
G6 rt-CGM during the 14-day study period, (ii) accuracy of the idi-CGM during
the standardized meal test and (iii) usability and satisfaction with the
idi-CGM. Accuracy will (primarily) be analysed as according to the guidelines
for Integrated Continuous Glucose Monitoring Approvals (Class II-510(K),
(Parkes) error grid-, bias (including MARD), correlation, stability and Bland-
Altman analysis.
Background summary
Continuous glucose monitoring (CGM) devices measure glucose concentrations
continuously in the interstitial fluid. Accurate glucose measurements are of
utmost importance for persons with diabetes mellitus (DM) as they guide
management decisions. Sensible Healthcare Systems developed a novel real-time
CGM device (rt-CGM), the idi-CGM. This device consists of microneedles (~1 mm),
that are less invasive than currently available alternatives, and measures
glucose in the dermis.
Study objective
To establish the performance of the idi-CGM system among persons with DM.
Study design
Prospective non-randomized cohort study assessing the performance of the
idi-CGM as compared to the gold standard (capillary measurements using Contour
Plus Blue monitoring system (Ascencia Diabetes Care) and a commonly used
real-time CGM (rt-CGM) device (Dexcom G6). Measurements will be performed
during a 14-day study period which includes an in-clinic visit to perform a
standardized glucose load test.
Intervention
Patients wear a new device that measures glucose.
Study burden and risks
Participants will be asked to wear two glucose monitoring devices at once and
to measure their capillary blood glucose levels at regular intervals (at least
4, but preferably 7 times daily). Furthermore, there is a 2-hour in-hospital
standardized glucose challenge test.
Dr. v. Heesweg 2
Zwolle 8025AB
NL
Dr. v. Heesweg 2
Zwolle 8025AB
NL
Listed location countries
Age
Inclusion criteria
- presence of type 1 DM;
- age between 18 and 75 years old.
Exclusion criteria
- A history of allergies towards (microneedle) patch substances/adhesive;
- The inability to understand the Dutch language;
- Oral of injected steroid using within the past 3 months
- Pregnancy or planned pregnancy
- Uncontrolled thyroid disease or hypertension
- Poor visual acuity
- Inability or unwillingness to meet the protocol requirements
- Any severe or uncontrolled medical or psychological condition which, in the
opinion of the investigator, would compromise the ability to meet protocol
requirements.
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 | NL77715.000.22 |