NCT02379299

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2017

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2016

First QC Date

February 27, 2015

Last Update Submit

August 8, 2017

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

  • Percentage of time with glucose values < 3.9 mmol/l as measured by Continuous Glucose Monitoring and Yellow Spring Instruments

    Every 5 minutes for 33 hours (total duration of each study arm)

  • Number of CHO interventions to treat hypoglycemia

    33 hours (total duration of each study arm)

Study Arms (2)

Single-hormone closed-loop control

ACTIVE COMPARATOR

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

Dual-hormone closed-loop control

EXPERIMENTAL

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

Interventions

DiaCon dual-hormone closed-loop glucose control algorithmDEVICE

Dual-hormone closed-loop glucose control

Dual-hormone closed-loop control
DiaCon single-hormone closed-loop glucose control algorithmDEVICE

Single-hormone closed-loop glucose control

Single-hormone closed-loop control

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

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
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 27, 2015

First Posted

March 4, 2015

Primary Completion

July 22, 2017

Last Updated

August 9, 2017

Record last verified: 2016-08

Locations

DK(1)