- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03443713
Evaluation of Physician-based Decision Support
March 16, 2020 updated by: Jessica Castle, Oregon Health and Science University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health and Science University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aerobic exercise
Subjects in this arm will complete aerobic exercise at home and at OHSU for the study.
Subjects will use a Dexcom G6 CGM.
|
Subjects will wear a Dexcom G6 CGM for the 28 days they are on study.
|
Experimental: Anaerobic exercise
Subjects in this arm will complete anaerobic exercise at home and at OHSU for the study.
Subjects will use a Dexcom G6 CGM.
|
Subjects will wear a Dexcom G6 CGM for the 28 days they are on study.
|
Experimental: High intensity interval exercise
Subjects in this arm will complete high intensity interval exercise at home and at OHSU for the study.
Subjects will use a Dexcom G6 CGM.
|
Subjects will wear a Dexcom G6 CGM for the 28 days they are on study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Time With Sensed Glucose 70-180 mg/dl
Time Frame: Days 1-7
|
Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using values uploaded to Dexcom Clarity.
The percent of time with sensed glucose 70-180 mg/dl was averaged across days 1-7.
|
Days 1-7
|
Percent of Time With Sensed Glucose Less Than 70 mg/dl
Time Frame: Days 1-7
|
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less than 70 mg/dl was averaged across days 1-7.
|
Days 1-7
|
Percent of Time With Sensed Glucose 70-180 mg/dl
Time Frame: Days 22-28
|
Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose 70-180 mg/dl was averaged across days 22-28.
|
Days 22-28
|
Percent of Time With Sensed Glucose Less Than 70 mg/dl
Time Frame: Days 22-28
|
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less then 70 mg/dl was averaged across days 22-28.
|
Days 22-28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Time With Sensed Glucose Less Than 54 mg/dl
Time Frame: Days 1-7
|
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less then 54 mg/dl was averaged across days 1-7.
|
Days 1-7
|
Mean Sensed Glucose
Time Frame: Days 1-7
|
Assess the mean Dexcom G6 reported sensor glucose values using values uploaded to Dexcom Clarity.The mean sensed glucose was averaged across days 1-7.
|
Days 1-7
|
Percent of Time With Sensed Glucose Less Than 54 mg/dl
Time Frame: Days 22-28
|
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less then 54 mg/dl was averaged across days 22-28.
|
Days 22-28
|
Mean Sensed Glucose
Time Frame: Days 22-28
|
Assess the mean Dexcom G6 reported sensor glucose values using values uploaded to Dexcom Clarity.The mean sensed glucose was averaged across days 22-28.
|
Days 22-28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 18, 2018
Primary Completion (Actual)
May 8, 2019
Study Completion (Actual)
May 8, 2019
Study Registration Dates
First Submitted
February 16, 2018
First Submitted That Met QC Criteria
February 16, 2018
First Posted (Actual)
February 23, 2018
Study Record Updates
Last Update Posted (Actual)
March 18, 2020
Last Update Submitted That Met QC Criteria
March 16, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Exercise
-
Faculdade de Motricidade HumanaCompletedGreen Exercise | Indoor ExercisePortugal
-
Hasan Kalyoncu UniversityNot yet recruiting
-
University of HawaiiKlein Buendel, Inc.CompletedMomZing Exercise Videos Online | Standard Exercise DVDUnited States
-
Istanbul Medipol University HospitalCompletedPulmonary Rehabilitation | Exercise Capacity | Exercise TestTurkey
-
University Hospital MuensterGerman Federal Ministry of Education and ResearchUnknownAerobic Exercise | Anaerobic Exercise | Unchanged ConditionGermany
-
Paracelsus Medical UniversityDepartment of Psychiatry University of BonnRecruitingHealthy | Exercise | Physical Fitness | Exercise TestAustria
-
Nathaniel JenkinsCompletedExercise Training | Physical Exertion | Desire to ExerciseUnited States
-
University of GeorgiaRecruitingBiomarkers | Aerobic Exercise | Acute ExerciseUnited States
-
University of TaipeiCompletedAerobic Exercise | Massage | Anaerobic Exercise
-
University of Alberta, Physical EducationCompletedSedentary Behaviour | Adherence | Traditional Exercise | Lifestyle ExerciseCanada
Clinical Trials on Dexcom G6 CGM
-
Medical University of GdanskNot yet recruitingHyperglycemia | Infections | Hypoglycemia | Surgical Site Infection | PeritonitisPoland
-
Columbia UniversityDexCom, Inc.Not yet recruitingDiabetic KetoacidosisUnited States
-
Blanchard Valley Health SystemEnrolling by invitation
-
Universitaire Ziekenhuizen KU LeuvenDexCom, Inc.CompletedType 1 Diabetes MellitusBelgium
-
Nicole Ehrhardt, MDDexCom, Inc.CompletedObesity | Diabetes Mellitus, Type 2 | PreDiabetesUnited States
-
Emory UniversityCompletedEnd Stage Kidney DiseaseUnited States
-
Woman'sDexCom, Inc.CompletedGestational Diabetes Mellitus in PregnancyUnited States
-
Aalborg University HospitalAalborg University; Steno Diabetes Center NordjyllandCompletedType1diabetes | Hemodialysis | Type2DiabetesDenmark
-
University of MinnesotaRecruitingHyperglycemia | Very Low Birth Weight Infant | Very Preterm Maturity of InfantUnited States
-
Mayo ClinicSuspendedDiabetes MellitusUnited States