Evaluation of Physician-based Decision Support
Status: | Active, not recruiting |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 3/6/2019 |
Start Date: | July 18, 2018 |
End Date: | May 31, 2019 |
Evaluation of Physician-based Decision Support in Patients With Type 1 Diabetes on Multiple Daily Injection Therapy
The goal of this study is to assess the impact of physician-driven insulin setting changes in
type 1 patients using multiple daily injection insulin therapy with exercise. This is a short
outpatient study with multiple outpatient and home exercise sessions with an assigned type of
exercise.
type 1 patients using multiple daily injection insulin therapy with exercise. This is a short
outpatient study with multiple outpatient and home exercise sessions with an assigned type of
exercise.
Subjects will be on study for 28 days. Sensor glucose, exercise, insulin and meal data will
be collected during this time. Subjects will wear the Dexcom G6 CGM system and a physical
activity monitor. The Subjects will complete 2 exercise visits in-clinic and 4 exercise
visits as an outpatient. Subjects will be randomized to aerobic, anaerobic or high intensity
interval exercise sessions for 30 minutes each. Physicians will review CGM and insulin data
every 7 days and make insulin dose recommendations that the subject will adjust in the dose
calculator.
be collected during this time. Subjects will wear the Dexcom G6 CGM system and a physical
activity monitor. The Subjects will complete 2 exercise visits in-clinic and 4 exercise
visits as an outpatient. Subjects will be randomized to aerobic, anaerobic or high intensity
interval exercise sessions for 30 minutes each. Physicians will review CGM and insulin data
every 7 days and make insulin dose recommendations that the subject will adjust in the dose
calculator.
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).
- Use of multiple daily insulin injections (MDI).
- A1C ≥7.0% at the time of screening.
- Current use of a smart phone.
- 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.
- Allergy to aspart or glargine insulin.
- Need for uninterrupted treatment of acetaminophen.
- 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.
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Phone: 503-418-9070
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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