NCT04313803

Brief Summary

The purpose of this study is to replicate the positive impact observed in IRB #1050955, but conduct this over a shorter period to potentially maximize patient outcomes and make care more affordable. Intermountain intends to build a diabetes program with CGM based on the findings. Senior stakeholders, clinicians and operators are aligned on this vision including the Community Based Care triad, Executive Leadership Team, and our Diabetes Prevention Program.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

March 13, 2020

Last Update Submit

March 17, 2020

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2Diabetes

Keywords

Continuous glucose monitor (CGM)diabetesglucose

Outcome Measures

Primary Outcomes (1)

  • Cost of care for fee-for-value patients (specifically PMPM savings)

    For each patient, measure total variable cost of associated healthcare services and visits. Then compare the distribution of costs between randomized groups using the Wilcoxon rank-sum test, a non-parametric analogue of Student's t-test.

    1 April 2020 - 30 April 2021

Secondary Outcomes (2)

  • The count of primary care, specialist, and emergency department visits or hospital stays for those using CGM compared to historical utilization and the broader T2DM cohort within Intermountain Healthcare.

    1 April 2020 - 30 April 2021

  • Evaluation of HEDIS performance for those using CGM compared to historical utilization and the broader T2DM cohort within Intermountain Healthcare.

    1 April 2020 - 30 April 2021

Study Arms (3)

American Fork

CGM usage months 1 and 3

Device: CGM

Central Orem

CGM usage for month 1

Device: CGM

North Canyon, Saratoga Springs, and Lehi

CGM usage for 1-3 months

Device: CGM

Interventions

CGMDEVICE

Dexcom CGM system

American ForkCentral OremNorth Canyon, Saratoga Springs, and Lehi

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with type II diabetes treated at Intermountain Healthcare

You may qualify if:

  • Patients (18-80 years of age) with type ll diabetes, having an HbA1c ≥6.5%, treated within five Intermountain Healthcare Utah Valley clinics. Patients must have access to a smart phone to download applications, have Bluetooth capabilities for data sharing, and log/view their continuous glucose monitor (CGM) data.

You may not qualify if:

  • Patients who are pregnant, not classified as having diabetes based on A1c levels, and age ≤ 17 or ≥ 81 years, or diagnosis of dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Lee PA, Greenfield G, Pappas Y. The impact of telehealth remote patient monitoring on glycemic control in type 2 diabetes: a systematic review and meta-analysis of systematic reviews of randomised controlled trials. BMC Health Serv Res. 2018 Jun 26;18(1):495. doi: 10.1186/s12913-018-3274-8.

    PMID: 29940936BACKGROUND

  • Ekhlaspour L, Mondesir D, Lautsch N, Balliro C, Hillard M, Magyar K, Radocchia LG, Esmaeili A, Sinha M, Russell SJ. Comparative Accuracy of 17 Point-of-Care Glucose Meters. J Diabetes Sci Technol. 2017 May;11(3):558-566. doi: 10.1177/1932296816672237. Epub 2016 Oct 3.

    PMID: 27697848BACKGROUND

  • Verkuilen J. Explanatory Item Response Models: A Generalized Linear and Nonlinear Approach by P. de Boeck and M. Wilson and Generalized Latent Variable Modeling: Multilevel, Longitudinal and Structural Equation Models by A. Skrondal and S. Rabe-Hesketh. Psychometrika. 2006 Jun;71(2):415-418. doi: 10.1007/s11336-005-1333-7. No abstract available.

    PMID: 28197954BACKGROUND

  • Fong Y, Rue H, Wakefield J. Bayesian inference for generalized linear mixed models. Biostatistics. 2010 Jul;11(3):397-412. doi: 10.1093/biostatistics/kxp053. Epub 2009 Dec 4.

    PMID: 19966070BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Elizabeth Joy, MD, MPH

    Intermountain Health Care, Inc.

    PRINCIPAL INVESTIGATOR

  • Brad Isaacson, PhD, MBA, MSF, PMP

    Intermountain Health Care, Inc.

    STUDY DIRECTOR

Central Study Contacts

Elizabeth Joy, MD, MPH

CONTACT

(801) 442-3721liz.joy@imail.org

Brad Isaacson, PhD, MBA, MSF, PMP

CONTACT

(801) 442-5737brad.isaacson@imail.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2020

First Posted

March 18, 2020

Study Start

April 1, 2020

Primary Completion

October 30, 2020

Study Completion

April 30, 2021

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share