CompletedNCT03443713Updated Mar 18, 2020Results posted

Evaluation of Physician-based Decision Support

An interventional study of Dexcom G6 CGM in Type 1 Diabetes Mellitus, MDI and CGM, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-03-18.

Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 25
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Type 1 Diabetes Mellitus
MDI
CGM
Exercise

Browse trials for

Diabetes Mellitus, Type 1 3,513

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts 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

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 design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 25 participants (actual)

Study arms

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.
Device: Dexcom G6 CGM
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.
Device: Dexcom G6 CGM
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.
Device: Dexcom G6 CGM

Interventions

DeviceDexcom G6 CGM
Subjects will wear a Dexcom G6 CGM for the 28 days they are on study.

What researchers measure

Primary outcomes

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
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
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
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

Secondary outcomes

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
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
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
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

Results

Posted Mar 18, 2020

Participant flow

Start up Visit (2 Hours)

Participant flow — Start up Visit (2 Hours)
Milestone	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise
Started	8	8	9
Completed	8	8	9
Not completed	0	0	0

First at Home Period (9-14 Days)

Participant flow — First at Home Period (9-14 Days)
Milestone	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise
Started	8	8	9
Completed	8	8	8
Not completed	0	0	1
Withdrew: Withdrawal by subject	0	0	1

First Exercise Visit (1 Hour)

Participant flow — First Exercise Visit (1 Hour)
Milestone	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise
Started	8	8	8
Completed	8	8	8
Not completed	0	0	0

Dexcom Insertion Visit (30 Minutes)

Participant flow — Dexcom Insertion Visit (30 Minutes)
Milestone	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise
Started	8	8	8
Completed	8	8	8
Not completed	0	0	0

Second at Home Period (2-11 Days)

Participant flow — Second at Home Period (2-11 Days)
Milestone	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise
Started	8	8	8
Completed	8	8	8
Not completed	0	0	0

Second Exercise Visit (1 Hour)

Participant flow — Second Exercise Visit (1 Hour)
Milestone	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise
Started	8	8	8
Completed	8	8	8
Not completed	0	0	0

Third at Home Period (8-12 Days)

Participant flow — Third at Home Period (8-12 Days)
Milestone	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise
Started	8	8	8
Completed	8	8	8
Not completed	0	0	0

Close-out Visit (30 Minutes)

Participant flow — Close-out Visit (30 Minutes)
Milestone	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise
Started	8	8	8
Completed	8	8	8
Not completed	0	0	0

Outcome measures

PrimaryPercent 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
Reported as:: Mean · percentage of time

Percent of Time With Sensed Glucose 70-180 mg/dl
percentage of time	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise
Percent of Time With Sensed Glucose 70-180 mg/dl	58.8 ± 18.9	51.2 ± 10.8	59.3 ± 14.6

PrimaryPercent 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
Reported as:: Mean · percentage of time

Percent of Time With Sensed Glucose Less Than 70 mg/dl
percentage of time	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise
Percent of Time With Sensed Glucose Less Than 70 mg/dl	3.3 ± 3.5	2.4 ± 1.4	3.3 ± 2.2

PrimaryPercent 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
Reported as:: Mean · percentage of time

Percent of Time With Sensed Glucose 70-180 mg/dl
percentage of time	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise
Percent of Time With Sensed Glucose 70-180 mg/dl	53.6 ± 13.6	51.0 ± 16.0	50.4 ± 13.4

PrimaryPercent of Time With Sensed Glucose Less Than 70 mg/dl

Time frame:: Days 22-28
Reported as:: Mean · percentage of time

Percent of Time With Sensed Glucose Less Than 70 mg/dl
percentage of time	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise
Percent of Time With Sensed Glucose Less Than 70 mg/dl	3.8 ± 3.4	2.2 ± 2.4	3.1 ± 4.0

SecondaryPercent 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
Reported as:: Mean · percentage of time

Percent of Time With Sensed Glucose Less Than 54 mg/dl
percentage of time	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise
Percent of Time With Sensed Glucose Less Than 54 mg/dl	0.5 ± 0.8	0.4 ± 0.3	0.5 ± 0.4

SecondaryMean 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
Reported as:: Mean · mg/dl

Mean Sensed Glucose
mg/dl	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise
Mean Sensed Glucose	168.4 ± 28.7	177.7 ± 14.5	166.4 ± 25.7

SecondaryPercent of Time With Sensed Glucose Less Than 54 mg/dl

Time frame:: Days 22-28
Reported as:: Mean · percentage of time

Percent of Time With Sensed Glucose Less Than 54 mg/dl
percentage of time	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise
Percent of Time With Sensed Glucose Less Than 54 mg/dl	0.7 ± 0.8	0.5 ± 1.1	0.8 ± 1.2

SecondaryMean 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
Reported as:: Mean · mg/dl

Mean Sensed Glucose
mg/dl	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise
Mean Sensed Glucose	174.0 ± 22.1	184.1 ± 25.2	183.0 ± 33.1

Adverse events

Collected over 28 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Aerobic Exercise	0/8 (0%)	0/8 (0%)	2/8 (25%)
Anaerobic Exercise	0/8 (0%)	0/8 (0%)	0/8 (0%)
High Intensity Interval Exercise	0/9 (0%)	0/9 (0%)	3/9 (33.3%)

Most frequent other events

Most frequent other events
Event	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise
redness and swelling at sensor siteSkin and subcutaneous tissue disorders	1/8	0/8	0/9
upper respiratory infectionInfections and infestations	1/8	0/8	1/9
Shoulder injuryMusculoskeletal and connective tissue disorders	0/8	0/8	1/9
lightheadednessVascular disorders	0/8	0/8	1/9

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise	Total
<=18 years	0	0	0	0
Between 18 and 65 years	8	8	9	25
>=65 years	0	0	0	0

Age, Continuous
Age, Continuous(years)	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise	Total
Mean	31.8 ± 6.7	28.6 ± 6.0	29 ± 5.3	29.8 ± 5.9

Sex: Female, Male
Sex: Female, Male(Participants)	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise	Total
Female	4	5	6	15
Male	4	3	3	10

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise	Total
Hispanic or Latino	0	0	0	0
Not Hispanic or Latino	8	8	9	25
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise	Total
American Indian or Alaska Native	0	0	0	0
Asian	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	1	2	1	4
White	7	4	8	19
More than one race	0	2	0	2
Unknown or Not Reported	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Aerobic Exercise	Anaerobic Exercise	High Intensity Interval Exercise	Total
United States	8	8	9	25

Study locations

1 site

Oregon Health and Science University
Portland, Oregon 97239, United States

References and documents

Publications

Tyler NS, Mosquera-Lopez CM, Wilson LM, Dodier RH, Branigan DL, Gabo VB, Guillot FH, Hilts WW, El Youssef J, Castle JR, Jacobs PG. An artificial intelligence decision support system for the management of type 1 diabetes. Nat Metab. 2020 Jul;2(7):612-619. doi: 10.1038/s42255-020-0212-y. Epub 2020 Jun 1. PubMed 32694787 ↗

Study documents

Protocol and statistical analysis plan · Apr 18, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03443713
Lead sponsor: Oregon Health and Science University
Collaborators: DexCom, Inc.
Responsible party: Jessica Castle (Associate Professor, Oregon Health and Science University) — Principal investigator
First posted: Feb 23, 2018
Start date: Jul 18, 2018
Primary completion: May 8, 2019
Completion: May 8, 2019
Results posted: Mar 18, 2020
Last update: Mar 18, 2020

Study contacts

Jessica Castle, MD

principal investigator · Oregon Health and Science University

Peter Jacobs, PhD

principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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