Type 1 Diabetes MellitusNCT03443713

Evaluation of Physician-based Decision Support

A study testing Dexcom G6 CGM in people with Type 1 Diabetes Mellitus and MDI, run by Oregon Health and Science University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Type 1 Diabetes Mellitus, MDI, CGM
What is being tested?: Dexcom G6 CGM
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: 18 Jul 2018to 8 May 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Oregon Health and Science University
Portland, Oregon, 97239

Other trials in United States

About this study

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

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: Type 1 Diabetes Mellitus, MDI, CGM, Exercise
Being tested: Dexcom G6 CGM
Medical subject headings: Diabetes Mellitus, Type 1, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03443713
Study group	Role	What they receive
Aerobic exercise	Experimental	Subjects in this arm will complete aerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM. Receives: Device: Dexcom G6 CGM
Anaerobic exercise	Experimental	Subjects in this arm will complete anaerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM. Receives: Device: Dexcom G6 CGM
High intensity interval exercise	Experimental	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. Receives: Device: Dexcom G6 CGM

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days 22-28

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days 22-28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jul 20188 May 2019

First posted23 Feb 2018
Study start18 Jul 2018
Primary completion8 May 2019
Study completion8 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Subjects randomly assigned to one of three types of exercise.
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03443713
Sponsor's protocol ID: 18023
Status last verified: Mar 2020
First submitted: 16 Feb 2018
Last updated: 18 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 1 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Physician-based Decision Support in Patients With Type 1 Diabetes on Multiple Daily Injection Therapy
ClinicalTrials.gov ID: NCT03443713
Acronym / sponsor ID: 18023
Conditions: Type 1 Diabetes Mellitus, MDI, CGM, Exercise
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Oregon Health and Science UniversityUniversity, hospital or other
Collaborators: DexCom, Inc.
Study start: 18 Jul 2018 (actual)
Primary completion: 8 May 2019 (actual)
Study completion: 8 May 2019 (actual)
First posted: 23 Feb 2018 (actual)
Results: Posted 18 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Subjects randomly assigned to one of three types of exercise.

Arm	Type	Receives
Aerobic exercise	Experimental	Device: Dexcom G6 CGMSubjects in this arm will complete aerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.
Anaerobic exercise	Experimental	Device: Dexcom G6 CGMSubjects in this arm will complete anaerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.
High intensity interval exercise	Experimental	Device: Dexcom G6 CGMSubjects in this arm will complete high intensity interval exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (25 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dexcom G6 CGMSubjects will wear a Dexcom G6 CGM for the 28 days they are on study.	Device	Aerobic exercise, Anaerobic exercise, High intensity interval exercise

Primary outcome

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.
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.
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.
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.

4 secondary outcomes

Percent of Time With Sensed Glucose Less Than 54 mg/dl
Time frame: Days 1-7
Mean Sensed Glucose
Time frame: Days 1-7
Percent of Time With Sensed Glucose Less Than 54 mg/dl
Time frame: Days 22-28
Mean Sensed Glucose
Time frame: Days 22-28

Results and safety

Results posted to the registry on 18 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aerobic Exercise	8	8
Anaerobic Exercise	8	8
High Intensity Interval Exercise	9	9

Primary outcome: Percent of Time With Sensed Glucose 70-180 mg/dl

Time frame: Days 1-7. Mean (Standard Deviation). Unit: percentage of time

Measure	Aerobic Exercise n = 8	Anaerobic Exercise n = 8	High Intensity Interval Exercise n = 8
Value	58.8 (18.9)	51.2 (10.8)	59.3 (14.6)

Population analysed: 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.

Primary outcome: Percent of Time With Sensed Glucose Less Than 70 mg/dl

Time frame: Days 1-7. Mean (Standard Deviation). Unit: percentage of time

Measure	Aerobic Exercise n = 8	Anaerobic Exercise n = 8	High Intensity Interval Exercise n = 8
Value	3.3 (3.5)	2.4 (1.4)	3.3 (2.2)

Population analysed: 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.

Primary outcome: Percent of Time With Sensed Glucose 70-180 mg/dl

Time frame: Days 22-28. Mean (Standard Deviation). Unit: percentage of time

Measure	Aerobic Exercise n = 8	Anaerobic Exercise n = 8	High Intensity Interval Exercise n = 8
Value	53.6 (13.6)	51.0 (16.0)	50.4 (13.4)

Population analysed: 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.

Primary outcome: Percent of Time With Sensed Glucose Less Than 70 mg/dl

Time frame: Days 22-28. Mean (Standard Deviation). Unit: percentage of time

Measure	Aerobic Exercise n = 8	Anaerobic Exercise n = 8	High Intensity Interval Exercise n = 8
Value	3.8 (3.4)	2.2 (2.4)	3.1 (4.0)

Population analysed: 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 28 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aerobic Exercise	0 of 8 (0%)	2 of 8 (25%)	0 of 8
Anaerobic Exercise	0 of 8 (0%)	0 of 8 (0%)	0 of 8
High Intensity Interval Exercise	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32694787Tyler 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jessica Castle, MD principal investigator

Oregon Health and Science University

Peter Jacobs, PhD principal investigator

Oregon Health and Science University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dexcom G6 CGM in people with Type 1 Diabetes Mellitus and MDI, run by Oregon Health and Science University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Time With Sensed Glucose 70-180 mg/dl (time frame: Days 1-7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03443713, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.