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