Performance of a new real-time continuous glucose monitoring system: a validation study of the idi-CGM in type 1 diabetes

Conditions: diabetes mellitus
10018424

Registration Number: NL-OMON56615

Lead Sponsor: Isala Klinieken

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 15

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is the accuracy of the idi-CGM<br /><br>compared to Contour Plus Blue strip capillary measurement results during the<br /><br>14-day study period. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include (i) accuracy of the idi-CGM compared to the Dexcom<br /><br>G6 rt-CGM during the 14-day study period, (ii) accuracy of the idi-CGM during<br /><br>the standardized meal test and (iii) usability and satisfaction with the<br /><br>idi-CGM. Accuracy will (primarily) be analysed as according to the guidelines<br /><br>for Integrated Continuous Glucose Monitoring Approvals (Class II-510(K),<br /><br>(Parkes) error grid-, bias (including MARD), correlation, stability and Bland-<br /><br>Altman analysis.</p><br>