Continuous Correction

Hvidovre University Hospital

Status: Terminated

Conditions: Type 1 Diabetes

Treatments: Procedure: Continuous Correction

Study type: Interventional

Funder types: Other

Identifiers

NCT02162004

CC2014

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Continuous correction

Experimental group

Description:

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.

Treatment:

Procedure: Continuous Correction

Control

No Intervention group

Description:

Regular sensor-augmented pump therapy.