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Clinical Trials/NL-OMON31558
NL-OMON31558
Completed
Not Applicable

The development of a method for prediction of future glucose values using additional vital body signs. - glucose prediction

Máxima Medisch Centrum0 sites20 target enrollmentTBD
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Conditionsdiabetes mellitus10018424

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
diabetes mellitus
Sponsor
Máxima Medisch Centrum
Enrollment
20
Status
Completed
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
Observational invasive

Investigators

Sponsor
Máxima Medisch Centrum

Eligibility Criteria

Inclusion Criteria

  • •1\. Subject uses insulin pump paradigm 512/712, 515/ 715 or real time
  • •2\. Type 1 diabetes mellitus \* 1 year
  • •3\. Age \* 18 years
  • •4\. BMI \< 40\.0 kg/m2

Exclusion Criteria

  • •1\. Women of childbearing potential who are pregnant, breast\-feeding or intend to become pregnant within the next 26 weeks or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice). (Adequate contraceptive measures are defined as sterilization, intra\-uterine device, oral contraceptives or consistent use of barrier methods)
  • •2\. Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening.
  • •3\. Cardiac disease defined as NYHA class III or IV, unstable angina and/or myocardial infarction within 6 months prior to screening.
  • •4\.Uncontrolled hypertension (treated or untreated) as judged by the Investigator
  • •5\. Any disease or condition (such as renal, hepatic or cardiac) that according to the judgment of the investigator makes the subject unsuitable for participation in the trial.
  • •6\. Use of concomitant medication which may alter glucose metabolism including but not limited to: systemic (or inhaled) glucocorticoids or non\-selective beta\-blockers.
  • •7\. Substance abuse including abuse of anabolic steroids.
  • •8\. Mental incapacity or language barrier precluding adequate understanding and/or cooperation.

Outcomes

Primary Outcomes

Not specified

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