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Type 1 DiabetesPhase 2NCT02282254

Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Type 1 Diabètes Adults With Hypoglycemia Unawareness and Documented Nocturnal Hypoglycemia

A Phase 2 study testing Overnight intervention in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes
What is being tested?
Overnight intervention
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteCanada
Study dates
Oct 2014to Jul 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females ≥ 18 years of old.
  • Clinical diagnosis of type 1 diabetes for at least one year.
  • The subject will have been on insulin pump therapy for at least 3 months.
  • HbA1c ≤ 12%.
  • Hypoglycemia awareness or unawareness assessed by a questionnaire.
  • Documented NH during the run-in period.

Who cannot join

  • 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.
  • 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 snack contents.
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  • 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 snacks, not willing to change pump parameters, etc).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Institut de recherches cliniques de Montréal

    Montreal, Quebec, H2W 1R7

Other trials in Canada

About this study

Official title: An Open-label, Randomized, Cross-over Study to Assess the Efficacy of Single-hormone and Dual-hormone Closed-loop Strategy in Regulating Overnight Glucose Levels in Type 1 diabètes Adults With Hypoglycemia Unawareness and Documented Nocturnal Hypoglycemia

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 strategy would regulate glucose levels through the infusion of two hormones: insulin and glucagon.

The main objective of this project is to compare the efficacy of single-hormone and dual-hormone closed-loop strategy to regulate overnight glucose levels in a in-patient study in type 1 diabetes adults with hypoglycemia unawareness and documented nocturnal hypoglycemia.

The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating overnight glucose levels compared to single-hormone closed-loop strategy.

Read the detailed description

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 strategy would regulate glucose levels through the infusion of two hormones: insulin and glucagon.

The investigators aim to conduct the 1st randomized cross-over trial comparing single- hormone and dual-hormone closed-loop strategy to regulate overnight glucose levels. The investigators aim to compare the two interventions for 10 hours in two subgroups of adults with type 1 diabètes. Patients from both subgroups will present documented nocturnal hypoglycemia. One subgroup will consist of patients with hypoglycemia unawareness while the other subgroup will consist of patients with hypoglycemia unawareness. This study will allow to determine if there is a greater benefit of a closed-loop strategy in a higher-risk hypoglycemia unaware group.

Conditions
Type 1 Diabetes
Being tested
Overnight intervention
Keywords
Type 1 diabetes, Hypoglycemia unawareness, Nocturnal hypoglycemia, Closed-loop strategy, Artificial pancreas, Glucagon, Hypoglycemia, Insulin
Medical subject headings
Diabetes Mellitus, Type 1, Hypoglycemia, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Overnight interventionOther

    Subjects will be admitted at the research facility at 19:00. A cannula will be inserted into an arm or a hand vein for blood sampling purposes. On dual-hormone closed-loop visits, glucagon will be reconstituted according to the manufacturer's instructions and a MiniMed® Paradigm® Veo™ pump containing the glucagon solution will be installed. At 20:30, a snack containing 20g of carbohydrate will be given. Closed-loop strategy will start at 20:00 until 7:00 next morning. A glucose sensor reading will be entered manually in a tablet every 10 minutes. The tablet will generate a recommendation for the basal rates of insulin delivery and glucagon mini-boluses (glucagon recommendations will only be generated during the dual hormone closed-loop visits). Pumps' parameters will then be changed manually to implement the tablet generated recommendations.

Study groups in NCT02282254
Study groupRoleWhat they receive
Single-hormone closed-loop strategyActive comparatorNot described
Receives: Other: Overnight intervention
Dual-hormone closed-loop strategyActive comparatorNot described
Receives: Other: Overnight intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of time of plasma glucose levels spent below 4 mmol/L

    Measured: Up to 8 hours

Secondary outcomes (17)

  1. Percentage of time of plasma glucose levels spent between 4 and 8 mmol/L

    Measured: Up to 8 hours

  2. Percentage of time of plasma glucose levels spent between 4 and 10 mmol/L

    Measured: Up to 8 hours

  3. Percentage of time of plasma glucose levels spent below 3.5 mmol/L

    Measured: Up to 8 hours

  4. Percentage of time of plasma glucose levels spent below 3.3. mmol/L

    Measured: Up to 8 hours

  5. Percentage of time of plasma glucose levels spent above 8 mmol/L

    Measured: Up to 8 hours

  6. Percentage of time of plasma glucose levels spent above 10 mmol/L

    Measured: Up to 8 hours

  7. Area under the curve of plasma glucose levels spent below 4 mmol/L

    Measured: Up to 8 hours

  8. Area under the curve of plasma glucose levels spent below 3.5 mmol/L

    Measured: Up to 8 hours

  9. Area under the curve of plasma glucose levels spent below 3.3 mmol/L

    Measured: Up to 8 hours

  10. Area under the curve of plasma glucose levels spent above 8 mmol/L

    Measured: Up to 8 hours

  11. Area under the curve of plasma glucose levels spent above 10 mmol/L

    Measured: Up to 8 hours

  12. Mean plasma glucose levels

    Measured: Up to 8 hours

  13. Standard deviation of plasma glucose levels

    Measured: Up to 8 hours

  14. Total insulin delivery

    Measured: Up to 8 hours

  15. Total glucagon delivery

    Measured: Up to 8 hours

  16. Number of subjects experiencing at least one hypoglycemic event requiring oral treatment

    Measured: Up to 8 hours

  17. Total number of hypoglycemic events requiring treatment

    Measured: Up to 8 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02282254
Sponsor's protocol ID
CLASS-09
Status last verified
Nov 2016
First submitted
19 Oct 2014
Last updated
10 Nov 2016
Results posted
No
Data monitoring committee
No

Publications

  • Abitbol A, Rabasa-Lhoret R, Messier V, Legault L, Smaoui M, Cohen N, Haidar A. Overnight Glucose Control with Dual- and Single-Hormone Artificial Pancreas in Type 1 Diabetes with Hypoglycemia Unawareness: A Randomized Controlled Trial. Diabetes Technol Ther. 2018 Mar;20(3):189-196. doi: 10.1089/dia.2017.0353. Epub 2018 Feb 2.

    PubMed 29393675

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Overnight intervention in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of time of plasma glucose levels spent below 4 mmol/L (time frame: Up to 8 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02282254, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2016.

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