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Glucose Monitoring Comparison in Primary Care (GluCoCare)

Primary Purpose

Diabetes Mellitus, Type 2

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CGM

SMBG

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 Diabetes, Continuous Glucose Monitor, Blood Glucose Monitor, Self-Monitoring of Blood Glucose, Primary Care, Glycemic Control, Time In Range, Diabetes Distress, Insulin, A1C, Glucose Management, Comparative effectiveness

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18 to 75 (inclusive)
Diagnosis of type 2 diabetes
A1C 7.5% to 12% (inclusive) in the last 2 months. (If A1C is older than 2 months at the baseline visit, a point-of-care or lab A1C may be done for eligibility)
Insulin use with or without other classes of glycemia medication use
No significant comorbidities that could impair the ability of a primary care team to manage diabetes, including but not limited to end stage renal disease, cognitive impairment, active cancer, and pregnancy
Established care within the HealthPartners Care Group, no plans to move within the next year, and willing to participate for the duration of the study
Willing and able to follow procedures for collecting blinded CGM data at baseline, 6 and 12 months follow-up
Willing to complete surveys at baseline, 3, 6, 9 and 12 months.
Willing to use SMBG or CGM, depending on randomization, in the way that their care team recommends and/or how they feel is most useful in managing their diabetes
Not currently using personal CGM
Not planning to become pregnant

Exclusion Criteria:

Unwillingness or inability to provide informed consent
Deemed not suitable for participation in the study based on any other clinical criteria as determined by study investigator(s)

Sites / Locations

International Diabetes Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CGM (continuous glucose monitoring)

SMBG (Self-monitoring of blood glucose)

Arm Description

Use CGM, with availability of Ambulatory Glucose Profile (AGP) data, to monitor and manage glucose over 12 months, in individuals with type 2 diabetes on insulin with or without other glycemic therapies. Glucose management over the 12 months study period will be in primary care, using "usual care" resources.

Use SMBG, as currently used in primary care, to monitor and manage glucose over 12 months, in individuals with type 2 diabetes on insulin with or without other glycemic therapies. Glucose management over the 12 months study period will be in primary care, using "usual care" resources.

Outcomes

Primary Outcome Measures

Change in A1C

To evaluate the effectiveness of two glucose monitoring strategies to reduce A1C levels by measuring differential within-patient change by study arm in A1C (%) from baseline to 12 months.

Change in Diabetes Distress

To evaluate the effectiveness of two glucose monitoring strategies to reduce diabetes distress by measuring differential within-patient change by study arm in Diabetes Distress Scale scores from baseline to 12 months.

Secondary Outcome Measures

Full Information

NCT ID

NCT05222815

First Posted

January 24, 2022

Last Updated

May 11, 2023

Sponsor

HealthPartners Institute

Collaborators

Patient-Centered Outcomes Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT05222815

Brief Title

Glucose Monitoring Comparison in Primary Care

Acronym

GluCoCare

Official Title

Comparing Fingerstick Blood Glucose Monitoring Versus Continuous Glucose Monitoring in Primary Care

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

August 29, 2022 (Actual)

Primary Completion Date

July 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HealthPartners Institute

Collaborators

Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This research trial will randomize 30 primary care clinics and 354 patients in accordance with their primary care clinic assignment to 2 different glucose monitoring strategies (SMBG vs. CGM) and compare the effectiveness through a pragmatic clinic cluster randomized design, with active glycemic management in a "usual" primary care setting, over the course of a 12 month active study period.

Detailed Description

The trial will evaluate the comparative effectiveness of SMBG (self-monitoring of blood glucose, also known as blood glucose monitoring [BGM] or fingerstick blood glucose monitoring) vs. continuous glucose monitoring (CGM), in managing glucose levels in individuals with type 2 diabetes (T2D) using insulin, with or without other glycemic therapies, in a primary care setting. The study will use a 2-arm, parallel group, cluster-randomized trial over a 12-month period. 30 primary care clinics will be randomly assigned to either use SMBG for glucose monitoring (15 clinics), with ongoing glycemic management provided by usual care in primary care, or CGM for glucose monitoring (15 clinics), with ongoing glycemic management provided by usual care in primary care using CGM and Ambulatory Glucose Profile (AGP) reports in a typical clinic setting. The study will use glycemic monitoring devices available to participants using real-world resources to cover the cost of the devices, and will be fundamentally pragmatic in nature. 354 patients (approximately 12/clinic) will be enrolled over 13 months (12 months of active intervention) with an intention-to-treat primary analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

Type 2 Diabetes, Continuous Glucose Monitor, Blood Glucose Monitor, Self-Monitoring of Blood Glucose, Primary Care, Glycemic Control, Time In Range, Diabetes Distress, Insulin, A1C, Glucose Management, Comparative effectiveness

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

354 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CGM (continuous glucose monitoring)

Arm Type

Experimental

Arm Description

Arm Title

SMBG (Self-monitoring of blood glucose)

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

CGM

Intervention Description

Continuous glucose monitor (CGM)-based glucose monitoring

Intervention Type

Other

Intervention Name(s)

SMBG

Intervention Description

Self-monitoring of blood glucose (SMBG)-based glucose monitoring

Primary Outcome Measure Information:

Title

Change in A1C

Description

To evaluate the effectiveness of two glucose monitoring strategies to reduce A1C levels by measuring differential within-patient change by study arm in A1C (%) from baseline to 12 months.

Time Frame

12 months

Title

Change in Diabetes Distress

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 to 75 (inclusive) Diagnosis of type 2 diabetes A1C 7.5% to 12% (inclusive) in the last 2 months. (If A1C is older than 2 months at the baseline visit, a point-of-care or lab A1C may be done for eligibility) Insulin use with or without other classes of glycemia medication use No significant comorbidities that could impair the ability of a primary care team to manage diabetes, including but not limited to end stage renal disease, cognitive impairment, active cancer, and pregnancy Established care within the HealthPartners Care Group, no plans to move within the next year, and willing to participate for the duration of the study Willing and able to follow procedures for collecting blinded CGM data at baseline, 6 and 12 months follow-up Willing to complete surveys at baseline, 3, 6, 9 and 12 months. Willing to use SMBG or CGM, depending on randomization, in the way that their care team recommends and/or how they feel is most useful in managing their diabetes Not currently using personal CGM Not planning to become pregnant Exclusion Criteria: Unwillingness or inability to provide informed consent Deemed not suitable for participation in the study based on any other clinical criteria as determined by study investigator(s)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard M Bergenstal, MD

Organizational Affiliation

International Diabetes Center, HealthPartners Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Thomas W Martens, MD

Organizational Affiliation

International Diabetes Center, HealthPartners Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

International Diabetes Center

City

Saint Louis Park

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

12. IPD Sharing Statement

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Glucose Monitoring Comparison in Primary Care

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