beta
Trial Radar AI
One study matched filter criteria
Card View
Back to Search

Continuous Correction 2

Terminated
Clinical Trial NCT02162004 is an interventional study for Type 1 Diabetes that is terminated. It started on June 1, 2014 with plans to enroll 2 participants. Led by Hvidovre University Hospital, it is expected to complete by December 1, 2014. The latest data from ClinicalTrials.gov was last updated on August 31, 2016.
Brief Summary
The potential of currently available diabetes technologies could be further exploited. The investigators propose that sensor-augmented insulin pump therapy may be improved by continuous correction, i.e. continuous evaluation of the need for correction boluses. In practice, this is carried out by running the bolus calculator every 10 minutes. The glucose sensor will provide the bolus calculator with glucose input. Man...Show More
Official Title

Sensor-Augmented Continuous Correction in Insulin Pump-Treated Type 1 Diabetes

Conditions
Type 1 Diabetes
Other Study IDs
  • CC2014
NCT ID Number
NCT02162004
Start Date (Actual)
2014-06
Last Update Posted
2016-08-31
Completion Date (Estimated)
2014-12
Enrollment (Estimated)
2
Study Type
Interventional
PHASE
N/A
Status
Terminated
Keywords
Type 1 diabetes
Continuous Glucose Monitoring
Insulin pump
Sensor-augmented pump
Continuous correction of high blood glucose
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalContinuous 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
No InterventionControl
Regular sensor-augmented pump therapy.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Percentage of time CGM values are in the target range 3.9-8.0 mmol/l in the time period 8:00-17:00.
The primary outcome is difference in the percentage of time CGM values are in the target range 3.9-8.0 mmol/l in the time period 8:00-17:00 on CC-days and Control-days.
Every 5 min for 9 hours on each study day.
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Mean CGM glucose value.
Every 5 min for 9 hours on each study day.
Percentage of time when CGM values are < 3.9 mmol/l.
Every 5 min for 9 hours on each study day.
Percentage of time when CGM values are > 8.0 mmol/l.
Every 5 min for 9 hours on each study day.
CGM standard deviation.
Every 5 min for 9 hours on each study day.
Number of hypoglycemic episodes.
Every 5 min for 9 hours on each study day.
Amount of insulin delivered.
Every 30 min for 9 hours on each study day.
Positive Incremental Area Under the Curve
Every 5 min for 9 hours on each study day.
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Age ≥ 18 years
  • T1D ≥ 3 years
  • CSII ≥ 1 year
  • HbA1c ≤ 8.0% (64 mmol/mol)

  • Pregnancy or nursing
  • 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
Hvidovre University Hospital logoHvidovre University Hospital
Study Responsible Party
Signe Schmidt, Principal Investigator, MD, Hvidovre University Hospital
No contact data.
1 Study Locations in 1 Countries
Hvidovre University Hospital, Hvidovre, 2650, Denmark