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Context Aware Data Gathering Study

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ClinicalTrials.gov Identifier: NCT04154904
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Jessica Castle, Oregon Health and Science University

Brief Summary:
Automated Insulin Delivery (AID) systems have now become an important standard-of-care for people with T1D and have demonstrated a reduction, but not elimination, of hypoglycemia during long-term studies. One limitation of current AID systems is that they have no knowledge about the context or environment that a person is currently experiencing. Contextual patterns can potentially improve the performance of an AID by recognizing environments or patterns of living that are related to changes in glucose. The team at OHSU is developing a context-aware glucose prediction algorithm that will capture context data from the patient both indoors and outdoors. This context data will be provided to the algorithm to allow for detecting contextual patterns that might relate to high or low glucose. The goal of this study will be the creation of a data set that will include contextual patterns along with glucose, insulin and physiological data.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Other: Exercise Not Applicable

Detailed Description:

Subjects will be on study for 28 days. Sensor glucose, activity, exercise, insulin, indoor and outdoor contextual patterns and meal data will be collected during this time. Subjects will wear the Dexcom G6 CGM system and a FitBit Ionic (or similar FitBit) or Apple Watch physical activity monitor for the entire 28 days. Subjects will continue to use their own insulin pump. Subjects will be asked to also wear a MotioWear indoor/outdoor context-aware tracking tag and to install the MotioWear beacons within their home. Subjects will be randomized to complete either aerobic, high intensity interval training, or resistance exercise videos twice weekly at home. Subjects will also ingest a self-selected meal 90 min prior to these prescribed exercise sessions. Subjects will eat a high carbohydrate meal once each week at the same approximate time of day (but not on the exercise days).

Subjects will use the T1 DEXI mobile app created by OHSU to capture meal and exercise data along with photos of meals over the 28 day period. While at home, subjects will check CBG before and after exercise, for symptoms of hypoglycemia, and for Dexcom G6 alarms for sensor <70 mg/dL and >250 mg/dL.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Development of a Context-aware Glucose Prediction Algorithm in Patients With Type 1 Diabetes
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Aerobic exercise Other: Exercise
Subjects will be randomized to complete either aerobic, high intensity interval training, or resistance exercise videos twice weekly at home.

Experimental: Resistance exercise Other: Exercise
Subjects will be randomized to complete either aerobic, high intensity interval training, or resistance exercise videos twice weekly at home.

Experimental: High intensity interval exercise Other: Exercise
Subjects will be randomized to complete either aerobic, high intensity interval training, or resistance exercise videos twice weekly at home.




Primary Outcome Measures :
  1. Comparison of hypoglycemia prediction against the Dexcom G6 CGM values using Mean Absolute Relative Error [ Time Frame: 28 days ]
  2. Comparison of hypoglycemia prediction against the Dexcom G6 CGM values using Mean Relative Error [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of type 1 diabetes mellitus for at least 1 year.
  • Male or female subjects 18 to 50 years of age.
  • Physically willing and able to perform 30 min of exercise (as determined by the investigator after reviewing the subject's activity level).
  • Current use of an insulin pump for at least 3 months.
  • A1C <10.0% at the time of screening.
  • Willingness to follow all study procedures, including attending all clinic visits.
  • Willingness to sign informed consent and HIPAA documents.

Exclusion Criteria:

  • Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
  • Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary.
  • Renal insufficiency (GFR < 60 ml/min, using the MDRD equation as reported by the OHSU laboratory).
  • Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator.
  • Hematocrit of less than 36% for men, less than 32% for women.
  • History of severe hypoglycemia during the past 12 months prior to screening visit or hypoglycemia unawareness as judged by the investigator. Subjects will complete a hypoglycemia awareness questionnaire. Subjects will be excluded for four or more R responses.
  • Adrenal insufficiency.
  • Any active infection.
  • Known or suspected abuse of alcohol, narcotics, or illicit drugs.
  • Seizure disorder.
  • Active foot ulceration.
  • Peripheral arterial disease.
  • Major surgical operation within 30 days prior to screening.
  • Use of an investigational drug within 30 days prior to screening.
  • Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
  • Bleeding disorder or platelet count below 50,000.
  • Current administration of oral or parenteral corticosteroids.
  • Any life threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer).
  • Beta blockers or non-dihydropyridine calcium channel blockers.
  • Current use of any medication intended to lower glucose other than insulin (ex. use of liraglutide).
  • A positive response to any of the questions from the Physical Activity Readiness Questionnaire with one exception: subject will not be excluded if he/she takes a single blood pressure medication that doesn't impact heart rate and blood pressure is controlled on the medication (blood pressure is less than 140/90 mmHg).
  • Any chest discomfort with physical activity, including pain or pressure, or other types of discomfort.
  • Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the subject's safety or compliance with 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): NCT04154904


Contacts
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Contact: Jessica Castle, MD 503-494-7072 castleje@ohsu.edu
Contact: Deborah Branigan, BA 503-418-9070 branigad@ohsu.edu

Locations
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United States, Oregon
Oregon Health and Science University Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Jessica Castle, MD    503-494-7072    castleje@ohsu.edu   
Contact: Deborah Branigan, BA    503-418-9070    branigad@ohsu.edu   
Principal Investigator: Peter Jacobs, PhD         
Sub-Investigator: Leah Wilson, MD         
Sub-Investigator: Joseph El Youssef, MD         
Sponsors and Collaborators
Oregon Health and Science University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Jessica Castle, MD Oregon Health and Science University

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Responsible Party: Jessica Castle, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT04154904     History of Changes
Other Study ID Numbers: 20248
1R01DK122583-01 ( U.S. NIH Grant/Contract )
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jessica Castle, Oregon Health and Science University:
automated insulin delivery systems
Context patterns
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases