Impact of Non-glucose Signals on Glycemic Control in Patients With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Observation During Exercise and Stress
Sponsored by
About this trial
This is an interventional other trial for Type 1 Diabetes Mellitus focused on measuring type 1 diabetes, hypoglycemia, exercise, stress, artificial pancreas, cortisol
Eligibility Criteria
Inclusion Criteria:
- Age 18-75 years
- Clinical diagnosis, based on investigator assessment, of T1D for at least one year and using insulin for at least 1 year.
- Using an insulin pump for diabetes therapy for at least 3 months
- Demonstration of proper mental status and cognition for the study
- Non-smoker
- If not currently using CGM, willing to use CGM during the study
- An understanding of and willingness to follow the protocol and sign the informed consent
Exclusion Criteria:
- Admission for diabetic ketoacidosis in the 6 months prior to enrollment unless study team feels the subject is appropriate for study given complete clinical context for subject
- Severe hypoglycemia resulting in seizure or loss of consciousness > once in the 6 months prior to enrollment
- History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist and not currently on a seizure medication
- Cystic fibrosis
- Unstable coronary artery disease or heart failure, unless written clearance is received from a cardiologist or primary care provider
A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
- Inpatient psychiatric treatment in the past 6 months
- Presence of a known adrenal disorder or chronic oral steroid therapy
- Abnormal liver function test results (Transaminase >3 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function
- Abnormal renal function test results (calculated GFR <60 mL/min/1.73m2);
- Active gastroparesis (defined actively being treated with medications)
- If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
- Abuse of alcohol or recreational drugs
- Pregnancy
- Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis).
- Uncontrolled arterial hypertension (Resting diastolic blood pressure >90 mmHg and/or systolic blood pressure >160 mmHg) at the time of screening
- Uncontrolled microvascular complications such as current active proliferative diabetic retinopathy defined as proliferative retinopathy requiring treatment (e.g. laser therapy) in the past 12 months.
- A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol.
Sites / Locations
- Sansum Diabetes Research Institute
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Observation of Exercise
Arm Description
Observation During Exercise and Stress
Outcomes
Primary Outcome Measures
Impact of Stress and Exercise on CGM Glucose Levels, determining how these factors affect time within target glucose range 70-180 mg/dl
Examine the impact of Stress and Exercise on CGM Glucose Levels, determining how these factors affect time within target glucose range 70-180 mg/dl. Correlate these factors that influence glycemic control to inform future algorithm development for an artificial pancreas (AP) device to better handle exercise and stress related events to be used in a future study.
Secondary Outcome Measures
CGM Glucose Levels 70-180 mg/dl
CGM Glucose Levels, within target range 70-180 mg/dl
CGM Glucose Levels less than 70 mg/dl
CGM Glucose Levels, less than 70 mg/dl
CGM Glucose Levels greater than 180 mg/dl
CGM Glucose Levels, greater than 180 mg/dl
Full Information
NCT ID
NCT03307850
First Posted
October 3, 2017
Last Updated
September 4, 2018
Sponsor
Sansum Diabetes Research Institute
Collaborators
Mayo Clinic, Harvard University
1. Study Identification
Unique Protocol Identification Number
NCT03307850
Brief Title
Impact of Non-glucose Signals on Glycemic Control in Patients With Type 1 Diabetes
Official Title
Feasibility Study to Assess the Impact of Non-glucose Signals on Glycemic Control in Patients With Type 1 Diabetes on Sensor Augmented Insulin Pump
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sansum Diabetes Research Institute
Collaborators
Mayo Clinic, Harvard University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
type 1 diabetes, hypoglycemia, exercise, stress, artificial pancreas, cortisol
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Observation of Exercise
Arm Type
Experimental
Arm Description
Observation During Exercise and Stress
Intervention Type
Other
Intervention Name(s)
Observation During Exercise and Stress
Intervention 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.
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.
Primary Outcome Measure Information:
Title
Impact of Stress and Exercise on CGM Glucose Levels, determining how these factors affect time within target glucose range 70-180 mg/dl
Description
Examine the impact of Stress and Exercise on CGM Glucose Levels, determining how these factors affect time within target glucose range 70-180 mg/dl. Correlate these factors that influence glycemic control to inform future algorithm development for an artificial pancreas (AP) device to better handle exercise and stress related events to be used in a future study.
Time Frame
5 Weeks
Secondary Outcome Measure Information:
Title
CGM Glucose Levels 70-180 mg/dl
Description
CGM Glucose Levels, within target range 70-180 mg/dl
Time Frame
5 Weeks
Title
CGM Glucose Levels less than 70 mg/dl
Description
CGM Glucose Levels, less than 70 mg/dl
Time Frame
5 Weeks
Title
CGM Glucose Levels greater than 180 mg/dl
Description
CGM Glucose Levels, greater than 180 mg/dl
Time Frame
5 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-75 years
Clinical diagnosis, based on investigator assessment, of T1D for at least one year and using insulin for at least 1 year.
Using an insulin pump for diabetes therapy for at least 3 months
Demonstration of proper mental status and cognition for the study
Non-smoker
If not currently using CGM, willing to use CGM during the study
An understanding of and willingness to follow the protocol and sign the informed consent
Exclusion Criteria:
Admission for diabetic ketoacidosis in the 6 months prior to enrollment unless study team feels the subject is appropriate for study given complete clinical context for subject
Severe hypoglycemia resulting in seizure or loss of consciousness > once in the 6 months prior to enrollment
History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist and not currently on a seizure medication
Cystic fibrosis
Unstable coronary artery disease or heart failure, unless written clearance is received from a cardiologist or primary care provider
A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
Inpatient psychiatric treatment in the past 6 months
Presence of a known adrenal disorder or chronic oral steroid therapy
Abnormal liver function test results (Transaminase >3 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function
Abnormal renal function test results (calculated GFR <60 mL/min/1.73m2);
Active gastroparesis (defined actively being treated with medications)
If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
Abuse of alcohol or recreational drugs
Pregnancy
Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis).
Uncontrolled arterial hypertension (Resting diastolic blood pressure >90 mmHg and/or systolic blood pressure >160 mmHg) at the time of screening
Uncontrolled microvascular complications such as current active proliferative diabetic retinopathy defined as proliferative retinopathy requiring treatment (e.g. laser therapy) in the past 12 months.
A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yogish C Kudva, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eyal Dassau, PhD
Organizational Affiliation
Harvard University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jordan E Pinsker, MD
Organizational Affiliation
Sansum Diabetes Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sansum Diabetes Research Institute
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93111
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Non-glucose Signals on Glycemic Control in Patients With Type 1 Diabetes
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