NL-OMON48870
Completed
Not Applicable
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 - ECSPECT-HYPO trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 124
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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