Improving preconceptional suboptimal glycaemic control in type 1 diabetes using RealTime Continuous Glucose Monitoring (RT-CGMS): A Randomised Clinical Trial.”

Suspended

Conditions: - preconceptional- real-time- glucose monitoring- diabetes type 1

Registration Number: NL-OMON26973

Lead Sponsor: Sponsor: University Medical Center Utrecht (UMCU) Adress: Heidelberglaan 100 postal code: 3584 CX city: Utrecht country: The Netherlands phone: +31 (0)88 75 555 55 email: info@umcutrecht.nl Postadres:Postbus 85500 3508 GA Utrecht

Brief Summary: Real-Time Continuous Glucose Monitoring System for Treatment of Diabetes, a Systematic Review". L.B.E.A. Hoeks, W.L. Greven et al. Diabetic Medicine. In Press.

Detailed Description: Not available

Recruitment & Eligibility

Status: Suspended

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1. Diagnosed with diabetes mellitus 1 at least for one year. Diagnosis: diagnosis < 30 years of age AND anti-GAD antibodies AND/OR experienced ketoacidosis;

2. Insulin pump (connectable with of changeable in a RT-CGMS device of Medtronic) for at least 3 months;

Exclusion Criteria

1. Co-existent medical problems that would interfere with study participation;

2. 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
Absolute reduction in HbA1c (HbA1c at the end of study versus HbA1c at inclusion).<br>

Secondary Outcome Measures

Name	Time	Method
1. Incidence of severe hypoglycaemia;<br /><br>2. Percentage of women with a fall in HbA1c of ≥ 0.4% (≥ 5 mmol/mol);<br /><br>3. Percentage of women that reach target HbA1c (<7.0% or < 53 mmol/mol);<br /><br>4. Time to reach target HbA1c (< 7.0% or < 53 mmol/mol);<br /><br>5. Numbers of consultations (at the clinic, by telephone, by email);<br /><br>6. Change in glycaemic variability;<br /><br>7. Composite end point: Reduction of HbA1 ≥ 0.4% (≥ 5 mmol/mol) without an episode of severe hypoglycaemia;<br /><br>8. Frequency of use RT-CGMS;<br /><br>9. Fear of hypoglycaemia;<br /><br>10. Quality-of-life;<br /><br>11. Satisfaction with the device.