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

NCT ID: NCT02855307

Last Updated: 2019-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Unannounced exercise

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

Group Type: ACTIVE_COMPARATOR

60-minute exercise

Intervention Type: 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.

Insulin pump

Intervention Type: DEVICE

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

Dexcom G4 Platinum glucose sensor

Intervention Type: DEVICE

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

Insulin

Intervention Type: DRUG

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

Single-hormone closed-loop strategy

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

60-minute exercise

Intervention Type: 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.

Insulin pump

Intervention Type: DEVICE

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

Dexcom G4 Platinum glucose sensor

Intervention Type: DEVICE

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

Insulin

Intervention Type: DRUG

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

Single-hormone closed-loop strategy

Intervention Type: 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 reduced insulin bolus

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

Group Type: ACTIVE_COMPARATOR

60-minute exercise

Intervention Type: 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.

Insulin pump

Intervention Type: DEVICE

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

Dexcom G4 Platinum glucose sensor

Intervention Type: DEVICE

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

Insulin

Intervention Type: DRUG

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

Single-hormone closed-loop strategy

Intervention Type: 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.

Interventions

60-minute exercise

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.

Intervention Type: OTHER

Insulin pump

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

Intervention Type: DEVICE

Dexcom G4 Platinum glucose sensor

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

Intervention Type: DEVICE

Insulin

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

Intervention Type: DRUG

Single-hormone closed-loop strategy

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Males and females ≥ 18 years of old.

2. Clinical diagnosis of type 1 diabetes for at least one year.

3. The subject will have been on insulin pump therapy for at least 3 months.

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

Exclusion Criteria

1. 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.

2. Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.

3. Use of medication with an effect on heart rate (e.g. beta-blockers).

4. Abnormal blood panel and/or anemia.

5. Ongoing or planned pregnancy.

6. Severe hypoglycemic episode within two weeks of screening.

7. 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).

8. Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).

9. Problems with venous access.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Recherches Cliniques de Montreal

OTHER

Sponsor Role: lead

Responsible Party

Rémi Rabasa-Lhoret

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rémi Rabasa-Lhoret

Role: PRINCIPAL_INVESTIGATOR

Institut de recherches cliniques de Montréal

Locations

Institut de recherches cliniques de Montréal

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 32740723 (View on PubMed)

Other Identifiers

CLASS-16

Identifier Type: -

Identifier Source: org_study_id