Continuous Correction

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02162004
• Other study ID #: CC2014
• Status: Terminated
• Phase: N/A
• First received: June 2, 2014
• Last updated: August 30, 2016
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Procedure:
• Continuous Correction

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean absolute relative difference.	CGM accuracy will be evaluated with Hemocue glucose values as reference (mean absolute relative difference).	Every 5 min for 9 hours on each study day.	No
Primary	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.	No
Secondary	Mean CGM glucose value.		Every 5 min for 9 hours on each study day.	No
Secondary	Percentage of time when CGM values are < 3.9 mmol/l.		Every 5 min for 9 hours on each study day.	Yes
Secondary	Percentage of time when CGM values are > 8.0 mmol/l.		Every 5 min for 9 hours on each study day.	No
Secondary	CGM standard deviation.		Every 5 min for 9 hours on each study day.	No
Secondary	Number of hypoglycemic episodes.		Every 5 min for 9 hours on each study day.	Yes
Secondary	Amount of insulin delivered.		Every 30 min for 9 hours on each study day.	No
Secondary	Positive Incremental Area Under the Curve		Every 5 min for 9 hours on each study day.	No