NCT01297946

Brief Summary

Recent developments of continuous glucose sensors and insulin infusion pumps have motivated the research toward closed-loop strategies to regulate glucose levels in patients with type 1 diabetes. In a closed-loop strategy, the pump(s) infusion rate is altered based on a computer-generated recommendation that relies on continuous glucose sensor readings. In this study, we aim to compare the effectiveness of dual-hormone (insulin+glucagon) closed-loop strategy to open-loop conventional continuous subcutaneous insulin infusion pump (CSII) therapy in regulating glucose levels during an evening exercise and on a night following an exercise in adults with type 1 diabetes.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2011

Completed
Last Updated

April 23, 2012

Status Verified

January 1, 2012

First QC Date

February 15, 2011

Last Update Submit

April 20, 2012

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Percentage of time of plasma glucose concentrations spent in target range (4.0-10.0 mmol/l from 4:00p.m.-11:00p.m. and 4.0-8.0 mmol/l from 11:00p.m.-7:00a.m.)

    4 p.m. - 7 a.m.

Secondary Outcomes (17)

  • Percentage of time of plasma glucose concentrations spent in the low range (< 4.0 mmol/l).

    4 p.m. - 7 a.m.

  • Percentage of time of plasma glucose concentrations spent in the high range (>10.0 mmol/l from 4:00p.m.-11:00 p.m. and >8.0 mmol/l from 11:00 p.m.-7:00 a.m.).

    4 p.m. - 7 a.m

  • Percentage of overnight time of plasma glucose concentrations spent in target range (4.0 - 8.0 mmol/l).

    11 p.m. - 7 a.m.

  • Percentage of overnight time of plasma glucose concentrations spent in the low range ( < 4.0 mmol/l).

    11 p.m. - 7 a.m.

  • Percentage of overnight time of plasma glucose concentrations spent in the high range (above 8 mmol/l).

    11 p.m. - 7 a.m.

  • +12 more secondary outcomes

Study Arms (2)

Open-loop

PLACEBO COMPARATOR

Conventional continuous subcutaneous insulin infusion (CSII) therapy

Device: Conventional continuous subcutaneous insulin infusion therapy

Dual-hormone closed-loop

EXPERIMENTAL

Variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels. The infusion rates are based on continuous glucose sensor reading and a control algorithm.

Device: Dual-hormone closed-loop

Interventions

Conventional continuous subcutaneous insulin infusion therapyDEVICE
Open-loop
Dual-hormone closed-loopDEVICE
Dual-hormone closed-loop

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of type 1 diabetes for at least one year.
  • On insulin pump therapy for at least 3 months.
  • HbA1c ≤ 10%.

You may not qualify if:

  • Clinically significant nephropathy, neuropathy or retinopathy.
  • Recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  • A recent injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol.
  • Pregnancy.
  • Severe hypoglycemic episode within two weeks of screening.
  • Current use of glucocorticoid medication (by any route of administration except low dose stable inhaled).
  • Known or suspected allergy to the trial products or meal contents.
  • Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
  • Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport).
  • Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Recherches Cliniques de Montréal (IRCM)

Montreal, Quebec, H2W 1R7, Canada

Location

Related Publications (2)

  • Heyland DK, Heyland R, Bailey A, Howard M. A novel decision aid to help plan for serious illness: a multisite randomized trial. CMAJ Open. 2020 Apr 28;8(2):E289-E296. doi: 10.9778/cmajo.20190179. Print 2020 Apr-Jun.

    PMID: 32345707DERIVED

  • Haidar A, Legault L, Dallaire M, Alkhateeb A, Coriati A, Messier V, Cheng P, Millette M, Boulet B, Rabasa-Lhoret R. Glucose-responsive insulin and glucagon delivery (dual-hormone artificial pancreas) in adults with type 1 diabetes: a randomized crossover controlled trial. CMAJ. 2013 Mar 5;185(4):297-305. doi: 10.1503/cmaj.121265. Epub 2013 Jan 28.

    PMID: 23359039DERIVED

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

  • Rémi Rabasa-Lhoret, M.D., Ph.D.

    Institut de Recherches Cliniques de Montréal (IRCM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2011

First Posted

February 17, 2011

Last Updated

April 23, 2012

Record last verified: 2012-01

Locations

CA(1)