Current state of impaired awareness of hypoglycaemia (IAH) in people with type 1 diabetes; change in prevalence, impact of glucose monitoring technology and psychosocial impact

Completed

• Conditions: diabetes; Insulin-Dependent Diabetes Mellitus 1; 10018424

• Registration Number: NL-OMON48008
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 700

Inclusion Criteria

- Diabetes mellitys type 1
- Age *16 years
- Ability to provide written informed consent
- Fluency in speaking and reading Dutch

Exclusion Criteria

- Severe psychiatric comorbidity
- Other comorbidity interfering with completing surveys, as judged by the
healthcare professional

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter will be the current prevalence of IAH and SH.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters will be:<br /><br>- Frequency of IAH change over years.<br /><br>- Difference in frequency of IAH/SH (new cases, changes in IAH state) in<br /><br>individuals who use RT-CGM/FGM compared to those who use traditional glucometer.<br /><br>- Odds ratio of factors contributing to development/prevention of SH/IAH change<br /><br>over time.<br /><br>- Answers to different (qualitative, quantitative) questionnaires (see<br /><br>appendix).</p><br>