Type 1 Diabetes Mellitus Clinical Trial
Official title:
Evaluation of Physician-based Decision Support in Patients With Type 1 Diabetes on Multiple Daily Injection Therapy
NCT number | NCT03443713 |
Other study ID # | 18023 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 18, 2018 |
Est. completion date | May 8, 2019 |
Verified date | March 2020 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | May 8, 2019 |
Est. primary completion date | May 8, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health and Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University | DexCom, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent of Time With Sensed Glucose 70-180 mg/dl | 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 | |
Primary | Percent of Time With Sensed Glucose Less Than 70 mg/dl | 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 | |
Primary | Percent of Time With Sensed Glucose 70-180 mg/dl | 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 | |
Primary | Percent of Time With Sensed Glucose Less Than 70 mg/dl | 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 | Percent of Time With Sensed Glucose Less Than 54 mg/dl | 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 | |
Secondary | Mean Sensed Glucose | 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 | |
Secondary | Percent of Time With Sensed Glucose Less Than 54 mg/dl | 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 | |
Secondary | Mean Sensed Glucose | 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 |
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