Improving preconceptional glycaemic regulation using RealTime Continuous Glucose Monitoring in women with type 1 diabetes who have *acceptable but not optimal* HbA1c values: an observational study
Phase 4
Withdrawn
- Conditions
- DiabetesDiabetes Mellitus10018424
- Registration Number
- NL-OMON35863
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
- diagnosed with diabetes mellitus 1 at least for one year diagnosis
- insulin pump for at least 3 months
- reliable performance of SMBG at least 5 times a day for at least 5 days a week
- child wish
- stable HbA1c 43-53 mmol/mol: the last 2 values +/- 3 mmol/mol
- willing to (patient herself) and capable of (as estimated by treating doctor) using RT-CGMS
- able to read and speak Dutch
- written informed consent
- internet access (uploading results sensor)
Exclusion Criteria
- co-existent medical problems that would interfere with study participation
- use of medication that could influence glycaemic control (for example corticosteroids) in last three months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome - Absolute reduction in HbA1c </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes<br /><br>- Incidence of severe hypoglycaemia<br /><br>- Percentage of women with a fall in HbA1c of >= 5 mmol/mol<br /><br>- number of consultations (by telephone, internet, on the out-patient clinic)<br /><br>- Change in glycaemic variability<br /><br>- Composite end point: reduction of HbA1 >= 5 mmol/mol without an episode of<br /><br>severe hypoglycemia<br /><br>- Frequency of use RT-CGMS - Fear of hypoglycaemia - Quality-of-life -<br /><br>Satisfaction with the device. </p><br>