diabetes mellitus type 1 insulin-dependent diabetes
Conditions
Interventions
Depending on the order, 16 weeks of use of real-time continuous glucose
monitoring (RT-CGM) and a 16-week period of masked continuous glucose
monitoring (CGM),.Both interventions are additional to u
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Type 1 diabetic patients - Use of multiple daily injections of insulin (with a basal insulin injection and bolus injections) or continuous subcutaneous insulin infusion - Any HbA1c - Age between 18 and 70 years old (inclusive) - IHA according to the questionnaire by Gold et al. (Diabetes Care 17:697-703, 1994) - Performing at least 3 SMBG/day or 21 SMBG/week
Exclusion criteria
Exclusion criteria: - Type 2 diabetes mellitus - History of (recent) major renal, liver, or (ischemic) heart disease (including cardiac conduction disorders) - Current untreated unstable diabetic retinopathy - Current (treatment for) malignancy - Current use of non-selective beta-blockers - Current psychiatric disorders, including schizophrenia, bipolar disorder, anorexia nervosa or bulimia nervosa - Substance abuse or alcohol abuse (men >21 units/week, women >14 units/week) - Current pregnancy or intention to conceive - Current use of RT-CGM other than for short term (i.e. diagnostic use or use shorter than 3 consecutive months) - Hearing or vision impairment hindering perceiving of glucose display and alarms, or otherwise incapable of using a (RT-)CGM, in the opinion of the investigator - Poor commandment of the Dutch language or any (mental) disorder that precludes full understanding of the purpose and instructions of the study - Participation in another clinical study - Known or suspected allergy to trial product or related products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean difference in time spent in the euglycemic range (interstitial glucose >3.9- | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) (Diabetes-specific) markers of QoL, as assessed with questionnaires, covering diabetes-related distress (PAID-5), fear of hypoglycemia (HFS-2), self-efficacy (CIDS), health status (EQ5D) and emotional well-being (WHO-5) 2) Other glycemia variables, including HbA1c and time spent in hypo- and hyperglycemia ranges, expressed in hours/day, averaged over 16 weeks of data gathering during the intervention period, spent as or below an interstitial glucose level of 3.9 or above an interstitial glucose level of 10.0 mmol/L, respectively, as determined by (RT-)CGM data during the respective intervention periods. 3) The incidence and duration of hypoglycemic episodes, expressed in hours/day, averaged over 16 weeks of data gathering during the intervention period, during which the patients* (RT-)CGM-measured interstitial glucose values are 3.9 mmol/L or below 3.9 mmol/L, according to (RT-)CGM data during the respective intervention periods. 4) Changes in hypoglycemia awareness score according to Gold et al. | — |
Countries
Netherlands
Outcome results
None listed