Status:
COMPLETED
Assessment of a Decision Support Tool in Participants With Type 1 Diabetes
Lead Sponsor:
Oregon Health and Science University
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Type 1 diabetes (T1D) is a complex disease with a high risk of both hyper- and hypoglycemia which can lead to severe acute and chronic complications. The burden and complexity of managing T1D results ...
Detailed Description
Subjects will be on study for 10 weeks. Subjects will begin the study with a training visit on the Dexcom G6 CGM system and the InPen and Clipsulin smart insulin pens. Subjects will use these devices ...
Eligibility Criteria
Inclusion
- Diagnosis of type 1 diabetes mellitus for at least 1 year.
- Male or female subjects 18 to 60 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) for at least 4 weeks at time of screening visit.
- A1C 7.0-10.0% 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
- 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.
- History of severe hypoglycemia during the past 6 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.
- 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).
- Allergy to aspart insulin.
- 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).
- Current use of any medication intended to lower glucose other than insulin (ex. use of liraglutide).
- Vision impairment which in the opinion of the investigator would preclude the use of the smart phone application.
- 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).
Key Trial Info
Start Date :
July 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04428645
Start Date
July 21 2020
End Date
November 15 2021
Last Update
July 19 2022
Active Locations (1)
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1
Oregon Health and Science University
Portland, Oregon, United States, 97239