Clinical trial NCT02162004: Continuous Correction
Official title: Sensor-Augmented Continuous Correction in Insulin Pump-Treated Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
Continuous Glucose Monitoring
Insulin pump
Sensor-augmented pump
Continuous correction of high blood glucose
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2014-06-12
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage of time CGM values are in the target range 3.9-8.0 mmol/l in the time period 8:00-17:00.
timeFrame: Every 5 min for 9 hours on each study day.
Secondary outcomes:
measure: Mean CGM glucose value.
timeFrame: Every 5 min for 9 hours on each study day.
measure: Percentage of time when CGM values are < 3.9 mmol/l.
timeFrame: Every 5 min for 9 hours on each study day.
measure: Percentage of time when CGM values are > 8.0 mmol/l.
timeFrame: Every 5 min for 9 hours on each study day.
measure: CGM standard deviation.
timeFrame: Every 5 min for 9 hours on each study day.
measure: Number of hypoglycemic episodes.
timeFrame: Every 5 min for 9 hours on each study day.
measure: Amount of insulin delivered.
timeFrame: Every 30 min for 9 hours on each study day.
measure: Positive Incremental Area Under the Curve
timeFrame: Every 5 min for 9 hours on each study day.
Other outcomes:
measure: Mean absolute relative difference.
timeFrame: Every 5 min for 9 hours on each study day.
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Signe Schmidt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: