NCT01754337

Brief Summary

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon. The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate glucose levels in a 24-hours in-patient study with standardized conditions in adults and adolescents with type 1 diabetes. The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating glucose levels in adults and adolescents with type 1 diabetes compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

December 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 21, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 4, 2014

Status Verified

July 1, 2014

Enrollment Period

1.5 years

First QC Date

December 13, 2012

Last Update Submit

July 3, 2014

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetesHypoglycemiaInsulinGlucagonClosed-loop systemArtificial pancreas

Outcome Measures

Primary Outcomes (1)

  • Percentage of time of plasma glucose levels spent in target range.

    Two-hour postprandial target range is between 4.0 and 10.0 mmol/l. Otherwise, target range is defined to be between 4.0 and 8.0 mmol/l.

    24 hours

Secondary Outcomes (14)

  • Percentage of time of plasma glucose levels spent in the low range

    24 hours

  • Percentage of overnight time of plasma glucose levels spent in the low range

    9 hours

  • Standard deviation of glucose levels

    24 hours

  • Total insulin delivery

    24 hours

  • Mean plasma glucose level

    24 hours

  • +9 more secondary outcomes

Study Arms (3)

Single-hormone closed-loop system

ACTIVE COMPARATOR

In single-hormone closed-loop system, variable subcutaneous insulin infusion rate will be used to regulate glucose levels.

Other: Closed-loop system

Dual-hormone closed-loop system

ACTIVE COMPARATOR

In dual-hormone closed-loop system, variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels.

Other: Closed-loop system

Insulin pump therapy

ACTIVE COMPARATOR

Patient's conventional treatment will be implemented.

Other: Closed-loop system

Interventions

Closed-loop systemOTHER

Patients will be admitted at the research clinical facility at 7:00. At 8:00, a mixed meal will be served. At 9:00, patients will be asked to perform two 30-min standardized activities. At 12:00, a mixed meal will be served. At 13:00, patients will be asked to perform two 30-min activities. At 17:00, a mixed meal will be served. At 19:30, patients will perform 60 minutes of aerobic treadmill exercise at an intensity of 60% VO2max. A bedtime snack of 20g carbohydrate will be given at 21:00. Patients will be discharged at 8:00 the next morning

Dual-hormone closed-loop systemInsulin pump therapySingle-hormone closed-loop system

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females ≥ 12 years of old.
  • Clinical diagnosis of type 1 diabetes for at least one year. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
  • The subject will have been on insulin pump therapy for at least 3 months.
  • HbA1c ≤ 12%.

You may not qualify if:

  • Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
  • 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 (except low stable dose).
  • 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 meals/snacks, 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

Montreal, Quebec, H2W 1R7, Canada

Location

Related Publications (1)

  • Haidar A, Legault L, Messier V, Mitre TM, Leroux C, Rabasa-Lhoret R. Comparison of dual-hormone artificial pancreas, single-hormone artificial pancreas, and conventional insulin pump therapy for glycaemic control in patients with type 1 diabetes: an open-label randomised controlled crossover trial. Lancet Diabetes Endocrinol. 2015 Jan;3(1):17-26. doi: 10.1016/S2213-8587(14)70226-8. Epub 2014 Nov 27.

    PMID: 25434967DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1HypoglycemiaInsulin Resistance

Condition Hierarchy (Ancestors)

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

Study Officials

  • Rémi Rabasa-Lhoret, MD, PhD

    Institut de recherches cliniques de Montréal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Medicine

Study Record Dates

First Submitted

December 13, 2012

First Posted

December 21, 2012

Study Start

December 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 4, 2014

Record last verified: 2014-07

Locations

CA(1)