Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2014-06-30
2014-12-31
Brief Summary
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The investigators hypothesize that sensor-augmented continuous correction insulin pump therapy can reduce hyperglycemia without increasing the risk of hypoglycemia in patients with type 1 diabetes.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Continuous correction
The insulin pump is set to automatically deliver the patient's usual insulin basal rate. The insulin pump bolus calculator is run every 10 minutes by the attending physician. Bolus calculations are based on glucose sensor values.
Continuous Correction
Control
Regular sensor-augmented pump therapy.
No interventions assigned to this group
Interventions
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Continuous Correction
Eligibility Criteria
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Inclusion Criteria
* T1D ≥ 3 years
* CSII ≥ 1 year
* HbA1c ≤ 8.0% (64 mmol/mol)
Exclusion Criteria
* Hypoglycemia unawareness
* Gastroparesis
* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to the study
* Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
18 Years
ALL
No
Sponsors
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Hvidovre University Hospital
OTHER
Responsible Party
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Signe Schmidt
MD
Principal Investigators
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Signe Schmidt, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hvidovre University Hospital
Locations
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Hvidovre University Hospital
Hvidovre, , Denmark
Countries
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Other Identifiers
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CC2014
Identifier Type: -
Identifier Source: org_study_id
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