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Evaluation of Physician-based Decision Support | Clinical Trials | Clareo Health

COMPLETEDNA

Evaluation of Physician-based Decision Support

Evaluation of Physician-based Decision Support in Patients With Type 1 Diabetes on Multiple Daily Injection Therapy

NCT03443713•Oregon Health and Science University

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

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.
+15 more criteria

Locations (1)

Oregon Health and Science University

Portland, Oregon, United States

Key Dates

Start Date

July 18, 2018

Primary Completion Date

May 8, 2019

Completion Date

May 8, 2019

Last Updated

March 18, 2020

Enrollment

ACTUAL participants

Conditions

Type 1 Diabetes MellitusMDICGMExercise

Interventions

Dexcom G6 CGM

DEVICE

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

Implementing the Spotlight AQ Platform in Adolescent/ Young Adult (16-25 Years Old) Type 1 Diabetics (T1D)

NCT06390371

Type 1 Diabetes Mellitus

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of Physician-based Decision Support

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