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Continuous Correction

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ClinicalTrials.gov Identifier: NCT02162004
Recruitment Status : Terminated (Technical problems)
First Posted : June 12, 2014
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
Signe Schmidt, Hvidovre University Hospital

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. Many times, the bolus calculator will come to the result that no insulin is needed. However, when the blood glucose is above the pre-set target value and a correction bolus is needed, an appropriate bolus is automatically delivered by the insulin pump.

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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Procedure: Continuous Correction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sensor-Augmented Continuous Correction in Insulin Pump-Treated Type 1 Diabetes
Study Start Date : June 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: 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.
Procedure: Continuous Correction
No Intervention: Control
Regular sensor-augmented pump therapy.



Primary Outcome Measures :
  1. Percentage of time CGM values are in the target range 3.9-8.0 mmol/l in the time period 8:00-17:00. [ Time Frame: Every 5 min for 9 hours on each study day. ]
    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.


Secondary Outcome Measures :
  1. Mean CGM glucose value. [ Time Frame: Every 5 min for 9 hours on each study day. ]
  2. Percentage of time when CGM values are < 3.9 mmol/l. [ Time Frame: Every 5 min for 9 hours on each study day. ]
  3. Percentage of time when CGM values are > 8.0 mmol/l. [ Time Frame: Every 5 min for 9 hours on each study day. ]
  4. CGM standard deviation. [ Time Frame: Every 5 min for 9 hours on each study day. ]
  5. Number of hypoglycemic episodes. [ Time Frame: Every 5 min for 9 hours on each study day. ]
  6. Amount of insulin delivered. [ Time Frame: Every 30 min for 9 hours on each study day. ]
  7. Positive Incremental Area Under the Curve [ Time Frame: Every 5 min for 9 hours on each study day. ]

Other Outcome Measures:
  1. Mean absolute relative difference. [ Time Frame: Every 5 min for 9 hours on each study day. ]
    CGM accuracy will be evaluated with Hemocue glucose values as reference (mean absolute relative difference).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • T1D ≥ 3 years
  • CSII ≥ 1 year
  • HbA1c ≤ 8.0% (64 mmol/mol)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162004


Locations
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Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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Principal Investigator: Signe Schmidt, MD, PhD Hvidovre University Hospital
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Responsible Party: Signe Schmidt, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02162004    
Other Study ID Numbers: CC2014
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: February 2015
Keywords provided by Signe Schmidt, Hvidovre University Hospital:
Type 1 diabetes
Continuous Glucose Monitoring
Insulin pump
Sensor-augmented pump
Continuous correction of high blood glucose
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases