Clinical Trials Directory

Trials / Completed

CompletedNCT03307850

Impact of Non-glucose Signals on Glycemic Control in Patients With Type 1 Diabetes

Feasibility Study to Assess the Impact of Non-glucose Signals on Glycemic Control in Patients With Type 1 Diabetes on Sensor Augmented Insulin Pump

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Sansum Diabetes Research Institute · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

This clinical trial will identify exercise-related and emotional stress related effects on glycemic control in patients with type 1 diabetes using sensor-augmented pump (SAP) therapy.

Detailed description

Patients with type 1 diabetes (T1D) on an insulin pump will be studied for 5 weeks in the outpatient setting performing their normal activities, to include their normal diet and exercise, while assessing the amount of type of exercise performed, and emotional stress levels, using stress sensor, questionnaires and salivary cortisol levels.

Conditions

Interventions

TypeNameDescription
OTHERObservation During Exercise and StressPatients with type 1 diabetes (T1D) on an insulin pump will be studied for 5 weeks in the outpatient setting performing their normal activities, to include their normal diet and exercise, while assessing the amount of type of exercise performed, and emotional stress levels, using stress sensor, questionnaires and salivary cortisol levels. Subjects at the William Sansum Diabetes Center will perform graded exercise on a treadmill for up to 45 minutes with all activity and stress monitors running, achieving 30 and 60% calculated heart rate reserve, once during the study. Subjects at Mayo Clinic will perform a graded exercise test on a treadmill to determine V02max and ensure stable cardiac status, once during the study.

Timeline

Start date
2017-11-01
Primary completion
2018-08-31
Completion
2018-08-31
First posted
2017-10-12
Last updated
2018-09-05

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT03307850. Inclusion in this directory is not an endorsement.