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

NCT03307850 | Completed

• 1 other identifier: JDRFSignals1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

type 1 diabetes; hypoglycemia; exercise; stress; artificial pancreas; cortisol

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• CGM Glucose Levels 70-180 mg/dl

  5 Weeks

• CGM Glucose Levels less than 70 mg/dl

  5 Weeks

• CGM Glucose Levels greater than 180 mg/dl

  5 Weeks

Study Arms (1)

Observation of Exercise

EXPERIMENTAL

Observation During Exercise and Stress

Other: Observation During Exercise and Stress

Interventions

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.

Observation of Exercise

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead
• Mayo Clinic: collaborator
• Harvard University: collaborator

Study Sites (2)

Sansum Diabetes Research Institute

Santa Barbara, California, 93111, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 12, 2017
• Study Start: November 1, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: September 5, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)