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ECSPECT-HYPO trial


- candidate number28362
- NTR NumberNTR6949
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-dec-2017
- Secondary IDsNL64474.029.18 METC
- Public TitleECSPECT-HYPO trial
- Scientific TitleEffectiveness 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.
- ACRONYMECSPECT-HYPO
- hypothesisA stepped-care approach starting with HypoAware intervention, with eventual additional continuous glucose monitoring (CGM), is more (cost-)effective compared with CGM only in type 1 diabetes patients with an impaired awareness of hypoglycemia.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 1 (DM type I), Hypoglycemia, Continuous glucose monitoring, Psychoeducation
- 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 Gold criteria (i.e., with a Gold score >=4) and 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 psychiatric disorders
- 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
- Any known or suspected allergy to trial-related products
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2018
- planned closingdate1-apr-2020
- Target number of participants115
- Interventions- Continuous glucose monitoring (CGM)
- Stepped Care: starting with HypoAware (step 1), a psycho-educational programme, and later adding CGM if needed (step 2)
- Primary outcomeFrequency of (self-reported) severe hypoglycemia
- Secondary outcomeHypoglycemia awareness (Gold score); frequency of mild hypoglycemia; glycosylated hemoglobin (HbA1c); results from the diagnostic glucose sensor: time spent in the euglycemic range (interstitial glucose >3.9-<10.0 mmol/L), sensor-derived hypoglycaemic events, nocturnal hypoglycemia, area under curve (AUC) ¡Ü3.9 mmol/L and glucose variability; psychological well-being: fear of hypoglycemia (Hypoglycemia Fear Survey (HFS-II)), diabetes-related distress (PAID); quality adjusted life years (QALYs) and societal costs consisting of costs of healthcare consumption, informal care and lost productivity.
- TimepointsBaseline, 3, 6, 12 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES C. Racca
- CONTACT for SCIENTIFIC QUERIES C. Racca
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZonMw
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD19-dec-2017 - 26-jan-2018


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