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

NCT ID: NCT03307850

Last Updated: 2018-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2018-08-31

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Observation of Exercise

Observation During Exercise and Stress

Group Type: EXPERIMENTAL

Observation During Exercise and Stress

Intervention Type: 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.

Interventions

Observation During Exercise and Stress

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.

Intervention Type: OTHER

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:

1. Inpatient psychiatric treatment in the past 6 months

2. Presence of a known adrenal disorder or chronic oral steroid therapy

3. 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

4. Abnormal renal function test results (calculated GFR <60 mL/min/1.73m2);

5. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

Harvard University

OTHER

Sponsor Role: collaborator

Sansum Diabetes Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yogish C Kudva, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Eyal Dassau, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard University

Jordan E Pinsker, MD

Role: PRINCIPAL_INVESTIGATOR

Sansum Diabetes Research Institute

Locations

Sansum Diabetes Research Institute

Santa Barbara, California, United States

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

JDRFSignals1

Identifier Type: -

Identifier Source: org_study_id