Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes

NCT02855307 | Completed Phase 2

• 1 other identifier: CLASS-16
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Regular physical activity is associated with many health benefits for individuals with type 1 diabetes including improved cardiovascular fitness and vascular health, decreased insulin requirements, improved body composition and quality of life. However, exercise-induced hypoglycemia is very frequent and thus is the main limiting factor for physical activity practice in this population. The artificial pancreas 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 artificial pancreas has the potential to reduce the risk of exercise-induced hypoglycemia but the importance of announcing exercise to the artificial pancreas is yet to be explored. The objective of this study is to investigate 1) if announcing postprandial exercise to the artificial pancreas is beneficial in reducing the risk of hypoglycemia and 2) if an insulin bolus reduction is necessary when announcing the exercise to the artificial pancreas.

Conditions

Type 1 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  From 9:30 to 11:30 (120 minutes)

Secondary Outcomes (14)

• Relative decrease in glucose levels during exercise compared to pre-breakfast levels

  From 8:00 to 10:50 (170 minutes)

• Number of patients experiencing exercise-induced hypoglycemia requiring treatment

  From 9:30 to 10:30 (60 minutes)

• Decremental area under the curve from the start of the exercise

  From 9:30 to 11:00 (90 minutes)

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

  From 9:30 to 10:30 (60 minutes)

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

  From 9:30 to 10:30 (60 minutes)

Study Arms (3)

Unannounced exercise

ACTIVE COMPARATOR

The target blood glucose of the algorithm will be as usual. A pre-meal full insulin bolus will be given.

Other: 60-minute exercise; Device: Insulin pump; Device: Dexcom G4 Platinum glucose sensor; Drug: Insulin; Other: Single-hormone closed-loop strategy

Announced exercise with pre-meal full bolus

ACTIVE COMPARATOR

The target blood glucose of the algorithm will be increased and a pre-meal full bolus will be given

Other: 60-minute exercise; Device: Insulin pump; Device: Dexcom G4 Platinum glucose sensor; Drug: Insulin; Other: Single-hormone closed-loop strategy

Announced exercise with reduced insulin bolus

ACTIVE COMPARATOR

The target blood glucose of the algorithm will be increased and the pre-meal insulin bolus will be reduced by 33%.

Other: 60-minute exercise; Device: Insulin pump; Device: Dexcom G4 Platinum glucose sensor; Drug: Insulin; Other: Single-hormone closed-loop strategy

Interventions

60-minute exercise OTHER

Patients will be admitted at the research clinical facility at 6:30. The artificial pancreas intervention will start at 7:00. A standardized breakfast will be served at 8:00. At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max. At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served. Patients will be discharged after lunch consumption.

Announced exercise with pre-meal full bolus; Announced exercise with reduced insulin bolus; Unannounced exercise

Insulin pump DEVICE

Patient's insulin pump will be used to infuse insulin.

Announced exercise with pre-meal full bolus; Announced exercise with reduced insulin bolus; Unannounced exercise

Dexcom G4 Platinum glucose sensor DEVICE

The Dexcom G4 Platinum glucose sensor will be used to measure glucose levels.

Announced exercise with pre-meal full bolus; Announced exercise with reduced insulin bolus; Unannounced exercise

Insulin DRUG

Patient's usual fast-acting insulin analog will be used.

Announced exercise with pre-meal full bolus; Announced exercise with reduced insulin bolus; Unannounced exercise

Single-hormone closed-loop strategy OTHER

Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump. The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes. The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.

Announced exercise with pre-meal full bolus; Announced exercise with reduced insulin bolus; Unannounced exercise

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.
• Last (less than 3 months) HbA1c ≤ 12%.

You may not qualify if:

• Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
• Recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
• Use of medication with an effect on heart rate (e.g. beta-blockers).
• Abnormal blood panel and/or anemia.
• Ongoing or planned pregnancy.
• Severe hypoglycemic episode within two weeks of screening.
• Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
• Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
• Problems with venous access.

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)

• Tagougui S, Taleb N, Legault L, Suppere C, Messier V, Boukabous I, Shohoudi A, Ladouceur M, Rabasa-Lhoret R. A single-blind, randomised, crossover study to reduce hypoglycaemia risk during postprandial exercise with closed-loop insulin delivery in adults with type 1 diabetes: announced (with or without bolus reduction) vs unannounced exercise strategies. Diabetologia. 2020 Nov;63(11):2282-2291. doi: 10.1007/s00125-020-05244-y. Epub 2020 Aug 1.

  PMID: 32740723 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity; Hypoglycemia; Insulin Resistance

Interventions

Exercise; Insulin Infusion Systems; Insulin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Drug Delivery Systems; Drug Therapy; Therapeutics; Infusion Pumps; Equipment and Supplies; Artificial Organs; Surgical Equipment; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Rémi Rabasa-Lhoret

  Institut de recherches cliniques de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 4, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 11, 2019

Record last verified: 2019-02

Locations

CA (1)