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Enrolling by Invitation

NCT Number: NCT05766488

Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients

Continuous glucose monitoring (CGM) has demonstrated improved outcomes in both type 1 and type 2 diabetes populations in comparison to traditional methods; however, these devices have not been well studied in underserved adult patients (e.g., low-income, uninsured) who may face additional barriers to monitoring. Furthermore, there is limited data exploring long-term (3- to 6- month) health care team-based management of these devices in the primary care setting. The purpose of this study is to further understand the benefits and barriers associated with CGM use in underserved populations with type 2 diabetes and improve their overall diabetes care.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nebraska Medicine

Omaha, Nebraska, 68198-7400D, United States

About this study

Continuous glucose monitoring (CGM) has demonstrated improved outcomes in both type 1 and type 2 diabetes populations in comparison to traditional methods; however, these devices have not been well studied in underserved adult patients (e.g., low-income, uninsured) who may face additional barriers to monitoring. Furthermore, there is limited data exploring long-term (3- to 6- month) health care team-based management of these devices in the primary care setting. This study will evaluate the perceived and experienced benefits and barriers of continuous glucose monitor (CGM) and traditional glucometer use and identify diabetes related outcomes associated with CGM use relative to usual care with self-monitoring of blood glucose (SMBG) in an underserved population.

Eligible adult (>=19 years of age) patients at participating clinics with type 2 diabetes, A1c >=9%, and concomitant insulin therapy and/or using two or more diabetes medications will be randomly enrolled to one of two groups: Freestyle Libre 2 CGM or traditional glucometer. Pre- and post-surveys will be used to evaluate perceived and experienced benefits and barriers to CGM use and diabetes-related outcomes will be compared between the groups using face-to-face, telephonic, and/or digital avenues. The latter aim will replicate current processes of team-based diabetes care which is blood glucose management from a pharmacist under collaborative practice with the primary care physician. Follow-up will also replicate these clinic processes throughout the 6-month period, including telephone calls and monthly in-clinic visits.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes
  • A1c >9% at recruitment
  • On/initiating insulin or on two or more diabetes medications

Exclusion criteria

  • Current use of an insulin pump
  • On dialysis
  • Pregnant
  • Implanted medical device (e.g., pace-maker, defibrillator)
  • Intellectual or physical disabilities that may interfere with ability to properly use the Continuous Glucose Monitor (CGM)
  • Able to read English

Treatment and study plan

Continuous Glucose Monitor (CGM)

Device

A Freestyle Libre 2 continuous glucose monitor (CGM) will be provided in the experimental arm of this study for 6 months.

Other names: Flash-glucose Monitor

Self-monitoring Blood Glucose (SMBG)

Device

A traditional glucometer device will be assigned in the active comparitor arm of this study for 6 months.

Other names: Traditional glucometer

Primary outcomes

  1. Glycemic Control (Hemoglobin A1c)

    Time frame: Baseline, 3 months, and 6 months.

    Glycemic control will be assessed by measuring hemoglobin A1c at baseline, 3 months, and 6 months. Values will be evaluated as a continuous variable and categorized as <7.0% vs >7.0% to <9.0% and >9.0%. Comparisons of the proportions of participants achieving a minimum of 1 point drop in hemoglobin A1c will be made between study arms.

Secondary outcomes

  1. Hypoglycemia

    Time frame: 6 months

    Continuous glucose monitor (CGM) and glucometer blood glucose data will be evaluated to determine number and percentage of hypoglycemic readings (i.e., <70 mg/dL). For CGM data, % time within target range, % time below specific thresholds for hypoglycemia) will be captured and described.

  2. Hyperglycemia

    Time frame: 6 months

    Continuous glucose monitor (CGM) and glucometer blood glucose data will be evaluated to determine percentage of hyperglycemic values (i.e., >180 mg/dl) experienced. For CGM data, % time within target range, % time below specific thresholds for hypoglycemia) will be captured and described.

  3. Blood Glucose Capture Rate

    Time frame: 6 months

    Number of days without any blood glucose recordings will be captured as a percentage over the study period.

  4. Perceived or Experienced Benefits and Barriers to Device Use

    Time frame: Baseline and 6 months

    A pre- and post-survey will be provided to all participants to qualitatively identify benefits and barriers to access and use of their assigned device and willingness to continue CGM use (follow-up survey).

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • Great Plains IDeA-CTR

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2023
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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