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Clinical Trials/NL-OMON36232
NL-OMON36232
Withdrawn
Phase 4

Improving preconceptional suboptimal glycaemic control in type 1 diabetes using RealTime Continuous Glucose Monitoring: a randomised trial - Preconceptional Glucose Regulation in type 1 diabetes women using RT-CGMS

Academisch Medisch Centrum0 sites20 target enrollmentTBD
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ConditionsDiabetesDiabetes Mellitus10018424

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Diabetes
Sponsor
Academisch Medisch Centrum
Enrollment
20
Status
Withdrawn
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Not specified

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