A 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.
ID
Bron
Verkorte titel
Aandoening
Diabetes type 1, Hypoglycaemia, Impaired awareness of hypoglycemia, Continuous glucose monitoring, Psychoeducation.
Diabetes type 1, Hypoglycaemie, Hypoproblematiek, Continue glucose monitoring, Psychoeducatie.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Frequency of (self-reported) severe hypoglycemia
Doel van het onderzoek
A 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.
Onderzoeksopzet
Baseline, 3, 6, 12 months
Onderzoeksproduct en/of interventie
- Continuous glucose monitoring (CGM)
- Stepped Care: starting with HypoAware (step 1), a psycho-educational programme, and later adding CGM if needed (step 2)
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6619 |
| NTR-old | NTR6949 |
| CCMO | NL64474.029.18 |
| OMON | NL-OMON48870 |