Effectiveness of Continuous Glucose Monitoring versus Stepped Care with HypoAware, a Web-Based PsychoEducational Intervention, and adding CGM as needed, in Adult Type 1 Diabetes with Impaired Hypoglycemia Awareness: ECSPECT-HYPO trial

Completed

• Conditions: 10018424; Diabetes type 1

• Registration Number: NL-OMON48870
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 124

Inclusion Criteria

- 18 years or older
- Type 1 diabetes, treated with either continuous subcutaneous insulin infusion
(CSII) or multiple daily insulin injections (MDI)
- Impaired awareness of hypoglycemia, as defined by at least one of the
following criteria: Gold criteria (i.e., with a Gold score >=4), or one or more
severe hypoglycemic events (defined as events requiring external assistance)
the past two years

Exclusion Criteria

- Renal insufficiency, with glomerular filtration rate (GFR) < 30 mL/min
- History of myocardial infarction in the last 3 months
- Current untreated proliferative diabetic retinopathy
- Current (treatment for) malignancy
- Current severe psychiatric disorders, in the opinion of the investigator
- Current substance abuse or alcohol abuse (men >21 units/week, women >14
units/week)
- Pregnancy or pregnancy wish
- Current use of FreeStyle Libre, acquired < 3 months prior to screening for
problems with hypoglycemia*s
- Any hearing or vision impairment that could hinder perception of the glucose
display and alarms, or otherwise incapable of using a (RT-)CGM, in the opinion
of the investigator
- Poor command of the Dutch language or any (mental) disorder that precluded
full understanding of the purpose and instructions of the study
- No accessibility to a computer
- Any known or suspected allergy to trial-related products

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Frequency of (self-reported) severe hypoglycemia. </p><br>