Continuous Correction

Not Applicable

Terminated

• Conditions: Type 1 Diabetes
• Interventions: Procedure: Continuous Correction

• Registration Number: NCT02162004
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-02
• Study First Submitted QC: 2014-06-10
• Study First Posted: 2014-06-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2016-08-30
• Last Update Posted: 2016-08-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Continuous correction	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.

Primary Outcome Measures

Name	Time	Method
Percentage of time CGM values are in the target range 3.9-8.0 mmol/l in the time period 8:00-17:00.	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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark