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Continuous Correction

Primary Purpose

Type 1 Diabetes

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Continuous Correction
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Continuous Glucose Monitoring, Insulin pump, Sensor-augmented pump, Continuous correction of high blood glucose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Continuous correction

Control

Arm 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.

Regular sensor-augmented pump therapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean CGM glucose value.
Percentage of time when CGM values are < 3.9 mmol/l.
Percentage of time when CGM values are > 8.0 mmol/l.
CGM standard deviation.
Number of hypoglycemic episodes.
Amount of insulin delivered.
Positive Incremental Area Under the Curve

Full Information

First Posted
June 2, 2014
Last Updated
August 30, 2016
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02162004
Brief Title
Continuous Correction
Official Title
Sensor-Augmented Continuous Correction in Insulin Pump-Treated Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
Technical problems
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 diabetes, Continuous Glucose Monitoring, Insulin pump, Sensor-augmented pump, Continuous correction of high blood glucose

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous correction
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Regular sensor-augmented pump therapy.
Intervention Type
Procedure
Intervention Name(s)
Continuous Correction
Primary Outcome Measure Information:
Title
Percentage of time CGM values are in the target range 3.9-8.0 mmol/l in the time period 8:00-17:00.
Description
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.
Time Frame
Every 5 min for 9 hours on each study day.
Secondary Outcome Measure Information:
Title
Mean CGM glucose value.
Time Frame
Every 5 min for 9 hours on each study day.
Title
Percentage of time when CGM values are < 3.9 mmol/l.
Time Frame
Every 5 min for 9 hours on each study day.
Title
Percentage of time when CGM values are > 8.0 mmol/l.
Time Frame
Every 5 min for 9 hours on each study day.
Title
CGM standard deviation.
Time Frame
Every 5 min for 9 hours on each study day.
Title
Number of hypoglycemic episodes.
Time Frame
Every 5 min for 9 hours on each study day.
Title
Amount of insulin delivered.
Time Frame
Every 30 min for 9 hours on each study day.
Title
Positive Incremental Area Under the Curve
Time Frame
Every 5 min for 9 hours on each study day.
Other Pre-specified Outcome Measures:
Title
Mean absolute relative difference.
Description
CGM accuracy will be evaluated with Hemocue glucose values as reference (mean absolute relative difference).
Time Frame
Every 5 min for 9 hours on each study day.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Signe Schmidt, MD, PhD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

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Continuous Correction

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