DiaCon Dual-Hormone Closed-Loop Glucose Control

August 8, 2017 updated by: Signe Schmidt, Hvidovre University Hospital

Dual-Hormone Closed-Loop Glucose Control in Type 1 Diabetes

The ultimate T1D treatment tool is a closed-loop glucose control system, i.e. a fully automated system for intensive insulin treatment. Such system will ease the burden of constant treatment decision-making and at the same time it has the potential to safely intensify insulin therapy such that more patients can reach treatment goals. Currently, no off-the-shelf closed-loop system exists but research efforts in this field have been intensified and resulted in great progress in recent years. Most closed-loop systems consist of an insulin pump, a CGM, and a control algorithm residing on a mobile computer that continuously (every 5-15 min) computes the optimal insulin dosage from the CGM values. For daytime blood glucose control, however, we believe that the system needs to be further advanced. Consequently, we have extended our single-hormone closed-loop system such that it now includes a second pump for glucagon delivery and correspondingly we have further developed our control algorithm to compute both insulin and glucagon dosages.

We hypothesize that we have developed a safe and effective dual-hormone closed-loop system for patients with type 1 diabetes and that this system is superior to single-hormone closed-loop therapy. The aims of this two-phase project are to 1) demonstrate proof-of-concept and 2) to compare dual-hormone with single-hormone closed-loop glucose control.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • T1D ≥ 2 years
  • Insulin pump therapy with rapid-acting analog insulin ≥ 1 year
  • HbA1c ≤ 8.5% (69 mmol/mol)
  • Ability and willingness to comply with all protocol procedures

Exclusion Criteria:

  • Pregnancy or nursing
  • Plan to become pregnant or sexually active and not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection)
  • Hypoglycemia unawareness (self-reported lack of hypoglycemia symptoms when blood glucose is < 3.0 mmol/l)
  • Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to study participation
  • History of coronary artery disease or congestive heart failure
  • Abnormal ECG suggestive of coronary artery disease and increased risk of malignant arrhythmia
  • Allergy to glucagon or lactose
  • Pheochromocytoma
  • Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Single-hormone closed-loop control
Closed-loop glucose control by use of insulin only by use of DiaCon single-hormone closed-loop glucose control algorithm
Device: DiaCon single-hormone closed-loop glucose control algorithm
Single-hormone closed-loop glucose control
Experimental: Dual-hormone closed-loop control
Closed-loop glucose control by use of insulin and glucagon by use of DiaCon dual-hormone closed-loop glucose control algorithm
Device: DiaCon dual-hormone closed-loop glucose control algorithm
Dual-hormone closed-loop glucose control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of time with glucose values < 3.9 mmol/l as measured by Continuous Glucose Monitoring and Yellow Spring Instruments
Time Frame: Every 5 minutes for 33 hours (total duration of each study arm)
Every 5 minutes for 33 hours (total duration of each study arm)
Number of CHO interventions to treat hypoglycemia
Time Frame: 33 hours (total duration of each study arm)
33 hours (total duration of each study arm)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Collaborators

Technical University of Denmark

Investigators

  • Principal Investigator: Signe Schmidt, MD, PhD, Hvidovre University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

July 22, 2017

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

February 27, 2015

First Posted (Estimate)

March 4, 2015

Study Record Updates

Last Update Posted (Actual)

August 9, 2017

Last Update Submitted That Met QC Criteria

August 8, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHCL2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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