Closed-loop Control of Glucose Levels (Artificial Pancreas) for 5 Days in Adults With Type 1 Diabetes

NCT02488616 | Withdrawn Phase 2

• 1 other identifier: CLASS-11
• Study Type: interventional
• Target: N/A
• 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. The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy and sensor-augmented pump therapy to regulate glucose levels in outpatient settings for 5 consecutive days in adults with type 1 diabetes. The investigators hypothesized that single-hormone closed-loop strategy will increase the time spent in the target range compared to sensor-augmented pump therapy.

Conditions

Type 1 Diabetes

Keywords

Closed-loop system; Artificial pancreas; Type 1 diabetes; Hypoglycemia; Insulin

Outcome Measures

Primary Outcomes (1)

• Percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L

  120 hours

Secondary Outcomes (41)

• Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L

  120 hours

• Percentage of time of glucose levels spent below 3.9 mmol/L

  120 hours

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

  120 hours

• Percentage of time of glucose levels spent below 2.8 mmol/L

  120 hours

• Percentage of time of glucose levels spent above 10 mmol/L

  120 hours

Study Arms (2)

Sensor-augmented pump therapy

ACTIVE COMPARATOR

Participants will use sensor-augmented pump therapy with low-glucose suspend to regulate glucose levels. The low-glucose suspend feature available in the MiniMed® Paradigm® Veo™, Medtronic combined with the Enlite sensor® will be used. This feature allows for suspension of insulin delivery at a pre-set sensor glucose value for up to 2 hours.

Other: 5-day intervention with sensor-augmented pump therapy; Device: Insulin pump; Device: Continuous glucose monitoring system; Drug: Insulin

Single-hormone closed-loop strategy

ACTIVE COMPARATOR

Variable subcutaneous insulin infusion will be used to regulate glucose levels. Participant's usual fast-acting insulin analog will be infused using a subcutaneous infusion pump (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to a smartphone, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pump.

Other: 5-day intervention with single-hormone closed-loop strategy; Device: Insulin pump; Device: Continuous glucose monitoring system; Drug: Insulin

Interventions

5-day intervention with single-hormone closed-loop strategy OTHER

A sensor will be inserted on the day prior to the first day of the intervention by the participants. On the first day of the intervention, participants will be admitted to the clinical research facility anytime between 8:00 am and 11:30 am. Training on connection and disconnection of the system, meal boluses, etc. will be given. Competency on the use of study devices will be assessed by a team member. Only participants demonstrating competency on use of study devices will be allowed to continue to the home study phase. Participants will be advised to continue with study intervention at home for the next 5 days.

Single-hormone closed-loop strategy

5-day intervention with sensor-augmented pump therapy OTHER

A sensor will be inserted on the day prior to the first day of the intervention by the participants. The participant will also have to install the study insulin pump. Participants will be advised to continue with study intervention at home for the next 5 days. Participants will have been previously shown how to use the study insulin pump.

Sensor-augmented pump therapy

Insulin pump DEVICE

MiniMed® Paradigm® Veo™, Medtronic

Sensor-augmented pump therapy; Single-hormone closed-loop strategy

Continuous glucose monitoring system DEVICE

Enlite sensor®, Medtronic

Sensor-augmented pump therapy; Single-hormone closed-loop strategy

Insulin DRUG

Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)

Sensor-augmented pump therapy; 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 ≤ 10%.
• Live in the area of Montreal.

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.
• Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
• Pregnancy (ongoing or current attempt to become pregnant).
• Severe hypoglycemic episode within two weeks of screening.
• Current use of glucocorticoid medication (except low stable dose and inhaled steroids).
• Known or suspected allergy to the trial products
• 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).

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead

Study Sites (1)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Insulin Resistance

Interventions

Methods; Insulin Infusion Systems; Continuous Glucose Monitoring; Insulin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques; Drug Delivery Systems; Drug Therapy; Therapeutics; Infusion Pumps; Equipment and Supplies; Artificial Organs; Surgical Equipment; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

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: June 26, 2015
• First Posted: July 2, 2015
• Study Start: March 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: January 31, 2018

Record last verified: 2018-01

Locations

CA (1)