CGM, Exercise, MDI, Type 1 Diabetes Mellitus
Conditions
Brief 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.
Interventions
DEVICEDexcom G6 CGM
Subjects will wear a Dexcom G6 CGM for the 28 days they are on study.
Sponsors
DexCom, Inc.
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Subjects randomly assigned to one of three types of exercise.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Time With Sensed Glucose 70-180 mg/dl | 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. |
| Percent of Time With Sensed Glucose Less Than 70 mg/dl | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Time With Sensed Glucose Less Than 54 mg/dl | 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. |
| Mean Sensed Glucose | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aerobic Exercise All study subjects were randomized to either aerobic, anaerobic or high intensity interval training. Subjects were on study for 28 days. | 8 |
| Anaerobic Exercise All study subjects were randomized to either aerobic, anaerobic or high intensity interval training. Subjects were on study for 28 days. | 8 |
| High Intensity Interval Exercise All study subjects were randomized to either aerobic, anaerobic or high intensity interval training. Subjects were on study for 28 days. | 9 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| First at Home Period (9-14 Days) | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 8 Participants | 9 Participants | 25 Participants |
| Age, Continuous | 31.8 years STANDARD_DEVIATION 6.7 | 28.6 years STANDARD_DEVIATION 6 | 29 years STANDARD_DEVIATION 5.3 | 29.8 years STANDARD_DEVIATION 5.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 8 Participants | 9 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 4 Participants | 8 Participants | 19 Participants |
| Region of Enrollment United States | 8 participants | 8 participants | 9 participants | 25 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 6 Participants | 15 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 9 |
| other Total, other adverse events | 2 / 8 | 0 / 8 | 3 / 9 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 9 |
Outcome results
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.
Time frame: Days 1-7
Population: 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise | Percent of Time With Sensed Glucose 70-180 mg/dl | 58.8 percentage of time | Standard Deviation 18.9 |
| Anaerobic Exercise | Percent of Time With Sensed Glucose 70-180 mg/dl | 51.2 percentage of time | Standard Deviation 10.8 |
| High Intensity Interval Exercise | Percent of Time With Sensed Glucose 70-180 mg/dl | 59.3 percentage of time | Standard Deviation 14.6 |
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.
Time frame: Days 22-28
Population: 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise | Percent of Time With Sensed Glucose 70-180 mg/dl | 53.6 percentage of time | Standard Deviation 13.6 |
| Anaerobic Exercise | Percent of Time With Sensed Glucose 70-180 mg/dl | 51.0 percentage of time | Standard Deviation 16 |
| High Intensity Interval Exercise | Percent of Time With Sensed Glucose 70-180 mg/dl | 50.4 percentage of time | Standard Deviation 13.4 |
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.
Time frame: Days 22-28
Population: 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise | Percent of Time With Sensed Glucose Less Than 70 mg/dl | 3.8 percentage of time | Standard Deviation 3.4 |
| Anaerobic Exercise | Percent of Time With Sensed Glucose Less Than 70 mg/dl | 2.2 percentage of time | Standard Deviation 2.4 |
| High Intensity Interval Exercise | Percent of Time With Sensed Glucose Less Than 70 mg/dl | 3.1 percentage of time | Standard Deviation 4 |
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.
Time frame: Days 1-7
Population: 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise | Percent of Time With Sensed Glucose Less Than 70 mg/dl | 3.3 percentage of time | Standard Deviation 3.5 |
| Anaerobic Exercise | Percent of Time With Sensed Glucose Less Than 70 mg/dl | 2.4 percentage of time | Standard Deviation 1.4 |
| High Intensity Interval Exercise | Percent of Time With Sensed Glucose Less Than 70 mg/dl | 3.3 percentage of time | Standard Deviation 2.2 |
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.
Time frame: Days 22-28
Population: 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise | Mean Sensed Glucose | 174.0 mg/dl | Standard Deviation 22.1 |
| Anaerobic Exercise | Mean Sensed Glucose | 184.1 mg/dl | Standard Deviation 25.2 |
| High Intensity Interval Exercise | Mean Sensed Glucose | 183.0 mg/dl | Standard Deviation 33.1 |
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.
Time frame: Days 1-7
Population: 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise | Mean Sensed Glucose | 168.4 mg/dl | Standard Deviation 28.7 |
| Anaerobic Exercise | Mean Sensed Glucose | 177.7 mg/dl | Standard Deviation 14.5 |
| High Intensity Interval Exercise | Mean Sensed Glucose | 166.4 mg/dl | Standard Deviation 25.7 |
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.
Time frame: Days 22-28
Population: 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise | Percent of Time With Sensed Glucose Less Than 54 mg/dl | 0.7 percentage of time | Standard Deviation 0.8 |
| Anaerobic Exercise | Percent of Time With Sensed Glucose Less Than 54 mg/dl | 0.5 percentage of time | Standard Deviation 1.1 |
| High Intensity Interval Exercise | Percent of Time With Sensed Glucose Less Than 54 mg/dl | 0.8 percentage of time | Standard Deviation 1.2 |
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.
Time frame: Days 1-7
Population: 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise | Percent of Time With Sensed Glucose Less Than 54 mg/dl | 0.5 percentage of time | Standard Deviation 0.8 |
| Anaerobic Exercise | Percent of Time With Sensed Glucose Less Than 54 mg/dl | 0.4 percentage of time | Standard Deviation 0.3 |
| High Intensity Interval Exercise | Percent of Time With Sensed Glucose Less Than 54 mg/dl | 0.5 percentage of time | Standard Deviation 0.4 |