Improving preconceptional suboptimal glycaemic control in type 1 diabetes using RealTime Continuous Glucose Monitoring: a randomised trial

Phase 4

Withdrawn

• Conditions: Diabetes; Diabetes Mellitus; 10018424

• Registration Number: NL-OMON36232
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- diagnosed with diabetes mellitus 1 at least for one year diagnosis: diagnosis < 30 years of age AND anti-GAD antibodies AND/OR experienced ketoacidosis
- insulin pump (connectable with of changeable in a RT-CGMS device of Medtronic) 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 7.0 - 7.7 (53-61 mmol/mol): if consecutive values (two months) show a decrease, this decrease is accepted up to (including) 0.5% (5 mmol/mol).
- age 18-41 years
- 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
- >=2 severe hypoglycaemia in the last 6 months (defined as an episode of hypoglycaemia resulting in seizure of coma or the use of glucagon and/or intravenous glucose for recovery)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome<br /><br>- 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 >= 0.5% (>= 5 mmol/mol)<br /><br>- Percentage f women that reach target HbA1c (< 7.0% or < 53 mmol/mol)<br /><br>- Time to reach target HbA1c<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 >= 0.5% (>= 5 mmol/mol) without an<br /><br>episode of severe hypoglycemia<br /><br>- Frequency of use RT-CGMS<br /><br>- Fear of hypoglycaemia<br /><br>- Quality-of-life<br /><br>- Satisfaction with the device.</p><br>