THE EFFECTS OF REAL-TIME CONTINUOUS GLUCOSE MONITORING ON GLYCEMIA AND QUALITY OF LIFE IN PATIENTS WITH TYPE 1 DIABETES MELLITUS AND IMPAIRED HYPOGLYCEMIA AWARENESS

Completed

Conditions: diabetes mellitus type 1
insulin-dependent diabetes
10012653

Registration Number: NL-OMON41465

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 52

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

- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The mean difference in time spent in the euglycemic range (interstitial glucose<br /><br>>3.9-<10.0 mmol/L), expressed as hours/day (primary endpoint) between the two<br /><br>16-week intervention periods, i.e. RT-CGM versus masked CGM in patients with<br /><br>T1DM and IHA.</p><br>

Secondary Outcome Measures