NCT02162004

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 12, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 31, 2016

Status Verified

February 1, 2015

Enrollment Period

6 months

First QC Date

June 2, 2014

Last Update Submit

August 30, 2016

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetesContinuous Glucose MonitoringInsulin pumpSensor-augmented pumpContinuous correction of high blood glucose

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (7)

  • Mean CGM glucose value.

    Every 5 min for 9 hours on each study day.

  • Percentage of time when CGM values are < 3.9 mmol/l.

    Every 5 min for 9 hours on each study day.

  • Percentage of time when CGM values are > 8.0 mmol/l.

    Every 5 min for 9 hours on each study day.

  • CGM standard deviation.

    Every 5 min for 9 hours on each study day.

  • Number of hypoglycemic episodes.

    Every 5 min for 9 hours on each study day.

  • +2 more secondary outcomes

Other Outcomes (1)

  • Mean absolute relative difference.

    Every 5 min for 9 hours on each study day.

Study Arms (2)

Continuous correction

EXPERIMENTAL

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.

Procedure: Continuous Correction

Control

NO INTERVENTION

Regular sensor-augmented pump therapy.

Interventions

Continuous CorrectionPROCEDURE
Continuous correction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • T1D ≥ 3 years
  • CSII ≥ 1 year
  • HbA1c ≤ 8.0% (64 mmol/mol)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Signe Schmidt, MD, PhD

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 2, 2014

First Posted

June 12, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 31, 2016

Record last verified: 2015-02

Locations

DK(1)