Status:

COMPLETED

Carbohydrate and Insulin Requirements During Prolonged Fasted Exercise

Lead Sponsor:

York University

Collaborating Sponsors:

Insulet Corporation

Conditions:

Type 1 Diabetes

Eligibility:

All Genders

18-65 years

Phase:

NA

Brief Summary

The purpose of this study is to compare the time spent in glucose target range (4.0-10.0 mmol/L) during exercise and in recovery using three different management strategies for prolonged aerobic exerc...

Detailed Description

This project focuses on the effectiveness of various exercise strategies on the time spent in target range during and after aerobic exercise in adults with type 1 diabetes (T1D) on continuous subcutan...

Eligibility Criteria

Inclusion

  • Clinical diagnosis of presumed autoimmune type 1 diabetes
  • Last HbA1c ≤ 9.9 percent
  • Age: 17+ years
  • Duration of T1D: ≥ 1.5 years
  • Using insulin pump therapy: ≥3 months (at least 0.25 units of insulin per kilogram of body mass)
  • In good general health with no conditions that could impact the outcome of the trial
  • Willing to adhere to the protocol requirements for the duration of the study

Exclusion

  • Physician diagnosis of active diabetic retinopathy that could be worsened by exercise
  • Physician diagnosis of peripheral neuropathy or autonomic neuropathy
  • Medications:
  • Beta-blockers
  • Agents that affect hepatic glucose production (xanthine derivatives)
  • Pramlintide
  • Any other hypoglycemic agent
  • Participation in other studies involving the administration of an investigational drug or device during the duration of the current study
  • Severe hypoglycemia in the last 3 months, defined as the individual requiring third party assistance or hospitalization

Key Trial Info

Start Date :

October 31 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 17 2019

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT04383015

Start Date

October 31 2018

End Date

October 17 2019

Last Update

May 11 2020

Active Locations (1)

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1

York University

Toronto, Ontario, Canada, M3J1P3