ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03307850
Recruitment Status : Recruiting
First Posted : October 12, 2017
Last Update Posted : April 12, 2018
Sponsor:
Collaborators:
Mayo Clinic
Harvard University
Information provided by (Responsible Party):
Sansum Diabetes Research Institute

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Other: Observation During Exercise and Stress Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Observation of Exercise
Observation During Exercise and Stress
Other: 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.




Primary Outcome Measures :
  1. Impact of Stress and Exercise on CGM Glucose Levels, determining how these factors affect time within target glucose range 70-180 mg/dl [ Time Frame: 5 Weeks ]
    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 :
  1. CGM Glucose Levels 70-180 mg/dl [ Time Frame: 5 Weeks ]
    CGM Glucose Levels, within target range 70-180 mg/dl

  2. CGM Glucose Levels less than 70 mg/dl [ Time Frame: 5 Weeks ]
    CGM Glucose Levels, less than 70 mg/dl

  3. CGM Glucose Levels greater than 180 mg/dl [ Time Frame: 5 Weeks ]
    CGM Glucose Levels, greater than 180 mg/dl



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307850


Locations
United States, California
Sansum Diabetes Research Institute Recruiting
Santa Barbara, California, United States, 93111
Contact: Camille Andre    805-682-7640 ext 217    candre@sansum.org   
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Shelly McCrady-Spitzer    507-255-0316    McCradySpitzer.Shelly@mayo.edu   
Sponsors and Collaborators
Sansum Diabetes Research Institute
Mayo Clinic
Harvard University
Investigators
Principal Investigator: Yogish C Kudva, MD Mayo Clinic
Principal Investigator: Eyal Dassau, PhD Harvard University
Principal Investigator: Jordan E Pinsker, MD Sansum Diabetes Research Institute

Responsible Party: Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier: NCT03307850     History of Changes
Other Study ID Numbers: JDRFSignals1
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sansum Diabetes Research Institute:
type 1 diabetes
hypoglycemia
exercise
stress
artificial pancreas
cortisol

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases