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

NCT02282254 | Completed Phase 2

• 1 other identifier: CLASS-09
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes; Hypoglycemia unawareness; Nocturnal hypoglycemia; Closed-loop strategy; Artificial pancreas; Glucagon; Hypoglycemia; Insulin

Outcome Measures

Primary Outcomes (1)

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

  Up to 8 hours

Secondary Outcomes (17)

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

  Up to 8 hours

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

  Up to 8 hours

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

  Up to 8 hours

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

  Up to 8 hours

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

  Up to 8 hours

Study Arms (2)

Single-hormone closed-loop strategy

ACTIVE COMPARATOR

Other: Overnight intervention

Dual-hormone closed-loop strategy

ACTIVE COMPARATOR

Other: Overnight intervention

Interventions

Overnight intervention OTHER

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.

Dual-hormone closed-loop strategy; Single-hormone closed-loop strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.
• 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.
• 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).

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead

Study Sites (1)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

Location

Related Publications (1)

• 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.

  PMID: 29393675 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Study Officials

• Remi Rabasa-Lhoret

  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: October 19, 2014
• First Posted: November 4, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 10, 2016

Record last verified: 2016-11

Locations

CA (1)