No registrations found.
ID
Source
Brief title
Health condition
Diabetes type 1, Hypoglycaemia, Impaired awareness of hypoglycemia, Continuous glucose monitoring, Psychoeducation.
Diabetes type 1, Hypoglycaemie, Hypoproblematiek, Continue glucose monitoring, Psychoeducatie.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Frequency of (self-reported) severe hypoglycemia
Secondary outcome
Hypoglycemia 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.
Study objective
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.
Study design
Baseline, 3, 6, 12 months
Intervention
- Continuous glucose monitoring (CGM)
- Stepped Care: starting with HypoAware (step 1), a psycho-educational programme, and later adding CGM if needed (step 2)
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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6619 |
| NTR-old | NTR6949 |
| CCMO | NL64474.029.18 |
| OMON | NL-OMON48870 |