Real time vs. Flash glucose monitoring in type 1 diabetes - a cross-over trial

Conditions: Diabetes mellitus
10018424

Registration Number: NL-OMON51332

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 48

Inclusion Criteria

- Type 1 diabetes mellitus (as defined by the American Diabetes Association
criteria) for >= 6 months
- Intensive insulin regimen consisting of MDI (basal-bolus with > 3
injections/day) or CSII established for more than 3 months
- Blood glucose control for >= 4 times per day, either using fingerprick
measurements, FSL-FGM or rt-CGM established for more than 3 months
- Age 18 to 75 years
- HbA1c < 10.5 % (91 mmol/mol), as determined - Normal hypoglycemia awareness (Gold score < 4)
- Internet and cellular phone coverage
- Dutch writing and speaking proficiency
- Ability to provide oral and written informed consent

Exclusion Criteria

- Oral of injected steroid using within the past 3 months
- Pregnancy or planned pregnancy
- Uncontrolled thyroid disease or uncontrolled hypertension
- Poor visual acuity
- Inability or unwillingness to meet the protocol requirements
- Severe cognitive impairment
- Any severe or uncontrolled medical or psychological condition which, in the
opinion of the investigator, would compromise the ability to meet protocol
requirements.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is the difference in percentage of time in the hypoglycemic<br /><br>(defined as glucose < 3.9 mmol/l) range, measured by blinded CGM during the<br /><br>last week of each treatment phase, between FGM and rt-CGM. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include changes in glucose control, sensor performance,<br /><br>changes in clinical parameters, PROs and PREs (including health related quality<br /><br>of life, treatment satisfaction, fear of hypoglycemia, diabetes distress and<br /><br>patient preference) during and between both treatment phases. </p><br>