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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| Harvard University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation of Exercise | Experimental | Observation During Exercise and Stress |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation During Exercise and Stress | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| CGM Glucose Levels 70-180 mg/dl | CGM Glucose Levels, within target range 70-180 mg/dl | 5 Weeks |
| CGM Glucose Levels less than 70 mg/dl | CGM Glucose Levels, less than 70 mg/dl |
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Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Yogish C Kudva, MD | Mayo Clinic | Principal Investigator |
| Eyal Dassau, PhD | Harvard University | Principal Investigator |
| Jordan E Pinsker, MD | Sansum Diabetes Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sansum Diabetes Research Institute | Santa Barbara | California | 93111 | United States | ||
| Mayo Clinic |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 5 Weeks |
| CGM Glucose Levels greater than 180 mg/dl | CGM Glucose Levels, greater than 180 mg/dl | 5 Weeks |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |