Continuous Correction

NCT ID: NCT02162004

Last Updated: 2016-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Continuous Correction

Intervention Type PROCEDURE

Control

Regular sensor-augmented pump therapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Continuous Correction

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Signe Schmidt

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Signe Schmidt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

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Hvidovre University Hospital

Hvidovre, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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CC2014

Identifier Type: -

Identifier Source: org_study_id

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