Diabetes MellitusCGMNCT04313803
CGM in Utah Valley
An observational study of Diabetes Mellitus and Diabetes Mellitus, Type 2, run by Intermountain Health Care, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes
- What is being tested?
- CGM
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with type II diabetes treated at Intermountain Healthcare
Who may be able to join
- 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.
Who cannot join
- Patients who are pregnant, not classified as having diabetes based on A1c levels, and age ≤ 17 or ≥ 81 years, or diagnosis of dementia.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Expanding Continuous CGM Usage to Improve Outcomes in a Shorter Duration in Utah Valley Clinics
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.
Read the detailed description
Overview
Approximately 30 million Americans, or 9% of the population has diabetes, a condition in which a person does not make enough insulin, or the body cannot use its own to effectively manage blood glucose levels. Improper diabetes management is associated with severe comorbidities which include: heart disease, stroke, kidney disease, ocular problems, dental disease, nerve damage, and vascularity issues. The epidemic continues to challenge systems like Intermountain Healthcare, an accountable care organization (ACO), since diabetes cost $327 billion per year (representing $1 in every $7 dollars spent) on healthcare in the United States. Furthermore, people with diagnosed diabetes incur average medical expenditures of $16,752 per year, of which about $9,601 is directly attributed to diabetes. New treatment options are needed to manage population health, especially with 84 million adults having been diagnosed with prediabetes diabetes.
In an effort to reduce the physical, economic and social burden of diabetes, several healthcare systems have evaluated the use of telehealth to monitor glucose levels. In a previous metanalysis, the authors demonstrated that telehealth interventions produced a small, but significant improvement in hemoglobin A1c (HbA1c) levels compared with usual care (mean difference: -0.55, 95% CI: -0.73 to - 0.36). The Ontario Health Technology Advisory Committee also showed that the blood glucose home telemonitoring technologies they used yielded a statistically significant reduction in HbA1c of ~0.50% in comparison to usual care when used adjunctively to a broader telemedicine initiative for adults with type 2 diabetes.
1.2 Previous Work
Intermountain Healthcare conducted a pilot study in the Reimagine Primary Care (RPC) clinics to evaluate if six months of CGM could improve patient outcomes (IRB #1050955). A total of 99 patients remained enrolled for the full time period (n=50 CGM, n=49 standard of care (SOC)), and data showed a improvement in glucose levels, less primary care and specialty appointments, a reduction in emergency department (ED) encounters, less labs ordered, and a cumulative body mass index (BMI) improvement. Furthermore, nearly all participants reported being willing to engage in another future pilot, and the vast improvements were attributed to subjects use of real-time data.
Primary analyses
Cost of care for fee-for-value patients (specifically PMPM savings)
Secondary analyses
Frequency of hypoglycemic events, healthcare utilization per count of inpatient/outpatient visits, cost of care, current HEDIS performance on diabetes and behavioral health measures, coding specificity for diabetes, emergency department visit per 1000 rate, overall and for patients with diabetes.
Power analyses
Data from IRB #1050955 has shown significant changes in cost, care and utilization with only a sample of 50 CGM users. The effect size is currently being calculated by the study statistician, but most of the outcome variables comparing CGM to standard of care device were p<0.05. Given that this will now include a much larger population, and 30x participant increase, the investigators will have sufficient power to deduce differences should they occur.
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes
- Being tested
- CGM
- Keywords
- Continuous glucose monitor (CGM), diabetes, glucose
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGMDevice
Dexcom CGM system
| Study group | Role | What they receive |
|---|---|---|
| American Fork | CGM usage months 1 and 3 Receives: Device: CGM | |
| Central Orem | CGM usage for month 1 Receives: Device: CGM | |
| North Canyon, Saratoga Springs, and Lehi | CGM usage for 1-3 months Receives: Device: CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Frequency of hypoglycemic events and healthcare utilization per count of inpatient/outpatient and emergency department visits per 1000 rate, overall and for patients with diabetes
Measured: 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.
Current HEDIS performance on diabetes and behavioral health measures
Measured: 1 April 2020 - 30 April 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Sponsor
- Investigators
- Elizabeth Joy, MD, MPH, Principal investigator, Intermountain Health Care, Inc.Brad Isaacson, PhD, MBA, MSF, PMP, Study director, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313803
- Sponsor's protocol ID
- IHC IRB#: 1051315
- Acronym
- CGM
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29940936Ekhlaspour 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.
PubMed 27697848Verkuilen 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.
PubMed 28197954Fong 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.
PubMed 19966070
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
- Expanding Continuous CGM Usage to Improve Outcomes in a Shorter Duration in Utah Valley Clinics
- ClinicalTrials.gov ID
- NCT04313803
- Acronym / sponsor ID
- CGM / IHC IRB#: 1051315
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes
- Keywords
- Continuous glucose monitor (CGM), diabetes, glucose
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Overview
Approximately 30 million Americans, or 9% of the population has diabetes, a condition in which a person does not make enough insulin, or the body cannot use its own to effectively manage blood glucose levels. Improper diabetes management is associated with severe comorbidities which include: heart disease, stroke, kidney disease, ocular problems, dental disease, nerve damage, and vascularity issues. The epidemic continues to challenge systems like Intermountain Healthcare, an accountable care organization (ACO), since diabetes cost $327 billion per year (representing $1 in every $7 dollars spent) on healthcare in the United States. Furthermore, people with diagnosed diabetes incur average medical expenditures of $16,752 per year, of which about $9,601 is directly attributed to diabetes. New treatment options are needed to manage population health, especially with 84 million adults having been diagnosed with prediabetes diabetes.
In an effort to reduce the physical, economic and social burden of diabetes, several healthcare systems have evaluated the use of telehealth to monitor glucose levels. In a previous metanalysis, the authors demonstrated that telehealth interventions produced a small, but significant improvement in hemoglobin A1c (HbA1c) levels compared with usual care (mean difference: -0.55, 95% CI: -0.73 to - 0.36). The Ontario Health Technology Advisory Committee also showed that the blood glucose home telemonitoring technologies they used yielded a statistically significant reduction in HbA1c of ~0.50% in comparison to usual care when used adjunctively to a broader telemedicine initiative for adults with type 2 diabetes.
1.2 Previous Work
Intermountain Healthcare conducted a pilot study in the Reimagine Primary Care (RPC) clinics to evaluate if six months of CGM could improve patient outcomes (IRB #1050955). A total of 99 patients remained enrolled for the full time period (n=50 CGM, n=49 standard of care (SOC)), and data showed a improvement in glucose levels, less primary care and specialty appointments, a reduction in emergency department (ED) encounters, less labs ordered, and a cumulative body mass index (BMI) improvement. Furthermore, nearly all participants reported being willing to engage in another future pilot, and the vast improvements were attributed to subjects use of real-time data.
Primary analyses
Cost of care for fee-for-value patients (specifically PMPM savings)
Secondary analyses
Frequency of hypoglycemic events, healthcare utilization per count of inpatient/outpatient visits, cost of care, current HEDIS performance on diabetes and behavioral health measures, coding specificity for diabetes, emergency department visit per 1000 rate, overall and for patients with diabetes.
Power analyses
Data from IRB #1050955 has shown significant changes in cost, care and utilization with only a sample of 50 CGM users. The effect size is currently being calculated by the study statistician, but most of the outcome variables comparing CGM to standard of care device were p<0.05. Given that this will now include a much larger population, and 30x participant increase, the investigators will have sufficient power to deduce differences should they occur.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| American Fork | – | Device: CGMCGM usage months 1 and 3 |
| Central Orem | – | Device: CGMCGM usage for month 1 |
| North Canyon, Saratoga Springs, and Lehi | – | Device: CGMCGM usage for 1-3 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type II diabetes treated at Intermountain Healthcare
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who are pregnant, not classified as having diabetes based on A1c levels, and age ≤ 17 or ≥ 81 years, or diagnosis of dementia.
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 |
|---|---|---|
| CGMDexcom CGM system | Device | American Fork, Central Orem, North Canyon, Saratoga Springs, and Lehi |
Primary outcome
Cost of care for fee-for-value patients (specifically PMPM savings)
Time frame: 1 April 2020 - 30 April 2021
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.
2 secondary outcomes
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.
Time frame: 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.
Time frame: 1 April 2020 - 30 April 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Background: PubMed 29940936Lee 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.
- Background: PubMed 27697848Ekhlaspour 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.
- Background: PubMed 28197954Verkuilen 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.
- Background: PubMed 19966070Fong 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.
- 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.
Elizabeth Joy, MD, MPH principal investigator
Intermountain Health Care, Inc.
Brad Isaacson, PhD, MBA, MSF, PMP study director
Intermountain Health Care, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Diabetes Mellitus, Type 2, run by Intermountain Health Care, Inc..
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 1 inclusion and 1 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: status not confirmed, 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Joy, MD, MPH ((801) 442-3721, liz.joy@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost of care for fee-for-value patients (specifically PMPM savings) (time frame: 1 April 2020 - 30 April 2021). 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 NCT04313803, which also lists 4 linked publications.
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.