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Glucose Monitoring Comparison in Primary Care (GluCoCare)

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ClinicalTrials.gov Identifier: NCT05222815
Recruitment Status : Enrolling by invitation
First Posted : February 3, 2022
Last Update Posted : September 1, 2022
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
HealthPartners Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: CGM Other: SMBG Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing Fingerstick Blood Glucose Monitoring Versus Continuous Glucose Monitoring in Primary Care
Actual Study Start Date : August 29, 2022
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Arms and Interventions
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Arm Intervention/treatment
Experimental: CGM (continuous glucose monitoring)
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.
 Other: CGM
Continuous glucose monitor (CGM)-based glucose monitoring
Active Comparator: SMBG (Self-monitoring of blood glucose)
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.
 Other: SMBG
Self-monitoring of blood glucose (SMBG)-based glucose monitoring


Outcome Measures
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Primary Outcome Measures :
  1. Change in A1C [ Time Frame: 12 months ]
    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.

  2. Change in Diabetes Distress [ Time Frame: 12 months ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 to 75 (inclusive)
  2. Diagnosis of type 2 diabetes
  3. 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)
  4. Insulin use with or without other classes of glycemia medication use
  5. 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
  6. 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
  7. Willing and able to follow procedures for collecting blinded CGM data at baseline, 6 and 12 months follow-up
  8. Willing to complete surveys at baseline, 3, 6, 9 and 12 months.
  9. 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
  10. Not currently using personal CGM
  11. Not planning to become pregnant

Exclusion Criteria:

  1. Unwillingness or inability to provide informed consent
  2. Deemed not suitable for participation in the study based on any other clinical criteria as determined by study investigator(s)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05222815


Locations
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United States, Minnesota
International Diabetes Center
Saint Louis Park, Minnesota, United States, 55416
Sponsors and Collaborators
HealthPartners Institute
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Richard M Bergenstal, MD International Diabetes Center, HealthPartners Institute
Principal Investigator: Thomas W Martens, MD International Diabetes Center, HealthPartners Institute
More Information
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Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT05222815    
Other Study ID Numbers: 19-326
First Posted: February 3, 2022    Key Record Dates
Last Update Posted: September 1, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HealthPartners Institute:
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
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases