Evaluation of Physician-based Decision Support

NCT03443713 | Completed Results FDA Device

• 1 other identifier: 18023
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus; MDI; CGM; Exercise

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• Percent of Time With Sensed Glucose Less Than 54 mg/dl

  Days 1-7

• Mean Sensed Glucose

  Days 1-7

• Percent of Time With Sensed Glucose Less Than 54 mg/dl

  Days 22-28

• Mean Sensed Glucose

  Days 22-28

Study Arms (3)

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.

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.

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.

Device: Dexcom G6 CGM

Interventions

Dexcom G6 CGM DEVICE

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

Aerobic exercise; Anaerobic exercise; High intensity interval exercise

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 32694787 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Results Point of Contact

• Title: Jessica Castle MD
• Organization: Oregon Health and Science University

castleje@ohsu.edu

503-494-7072

Study Officials

• Jessica Castle, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Peter Jacobs, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Subjects randomly assigned to one of three types of exercise.

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 23, 2018
• Study Start: July 18, 2018
• Primary Completion: May 8, 2019
• Study Completion: May 8, 2019
• Last Updated: March 18, 2020
• Results First Posted: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)