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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

Tracking Information
First Submitted Date  ICMJE January 24, 2022
First Posted Date  ICMJE February 3, 2022
Last Update Posted Date September 1, 2022
Actual Study Start Date  ICMJE August 29, 2022
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2022)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glucose Monitoring Comparison in Primary Care
Official Title  ICMJE Comparing Fingerstick Blood Glucose Monitoring Versus Continuous Glucose Monitoring in Primary Care
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Other: CGM
    Continuous glucose monitor (CGM)-based glucose monitoring
  • Other: SMBG
    Self-monitoring of blood glucose (SMBG)-based glucose monitoring
Study Arms  ICMJE
  • 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.
    Intervention: Other: CGM
  • 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.
    Intervention: Other: SMBG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: January 24, 2022)
354
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05222815
Other Study ID Numbers  ICMJE 19-326
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party HealthPartners Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE HealthPartners Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Richard M Bergenstal, MD International Diabetes Center, HealthPartners Institute
Principal Investigator: Thomas W Martens, MD International Diabetes Center, HealthPartners Institute
PRS Account HealthPartners Institute
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP