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Efficacy of Continuous Glucose Monitoring Relative to Traditional Self-Monitoring of Blood Glucose in Non-Insulin Treated Adults with Poorly Controlled T2DM

Award Number: R01DK149293
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2026
PERIOD OF PERFORMANCE END DATE: 06/30/2031

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Efficacy of Continuous Glucose Monitoring Relative to Traditional Self-Monitoring of Blood Glucose in Non-Insulin Treated Adults with Poorly Controlled T2DM - Project Summary Type 2 diabetes is associated with significant morbidity, mortality, and health care costs. Self-monitoring of blood glucose (SMBG) is a key component of diabetes self-management. There are two main methods for SMBG, the traditional finger-stick based self-monitoring, and emerging digital health technology assisted blood glucose monitoring such as continuous glucose monitoring (CGM). Systematic reviews and meta- analyses have established clinical advantages of CGM over traditional SMBG in T2DM. However, insurance coverage restricts CGMs to individuals with type 1 diabetes or type 2 on insulin and given that <25% of adults with type 2 diabetes are on insulin, it means that over 75% of individuals with type 2 do not have access to CGMs due to limited data on efficacy of CGMs in this population. This proposal responds to RFA-DK-26-315: Advancing Research on the Application of Digital Health Technology to the Management of Type 2 Diabetes (R01- Clinical Trail Required) and addresses three important gaps in the literature needed to increase availability and adoption of CGMs in non-insulin treated adults with type 2 diabetes. First, are CGMs superior to traditional finger-stick based SMBG in improving clinical (Hemoglobin A1c, blood pressure, and lipids); behavioral (diet, physical activity, and medication adherence); and quality of life outcomes in this population? Second, are CGMs cost-effective in this population? Third, is it sufficient to provide CGMs and basic education on how to use CGMs or are additional strategies (e.g., tailored health coaching) needed to achieve significant improvements in clinical, behavioral, and quality of life outcomes? Fourth, are the results of CGMs sustained past 12 months in this population? To address these important gaps, we propose a 3-arm RCT in which 300 adults with poorly controlled T2DM (HbA1c >=8%) who are not currently on insulin are randomized 1:1:1 to: 1) traditional fingerstix based SMBG (Fingerstix); 2) CGM with instructions on how to use them (CGM Only); and 3) CGMs plus tailored health coaching (CGM + Health Coaching) with primary clinical outcomes (glycemic, blood pressure, and lipid control) at 12 months and sustainability outcomes at 18 months. The secondary aims will investigate the efficacy on self-care behaviors (diet, physical activity, and medication adherence) and quality of life at 12 and 18 months and cost effectiveness of the CGM + Health Coaching and CGM Only arms relative to Fingerstix in terms of glycemic control, blood pressure, and lipid control at 12 and 18 months.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $799,752 )
2026	2026	THE RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK	520 LEE ENTRANCE STE 211	AMHERST	NY	14228	ERIE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	6/29/2026	NEW	$799,752
														Subtotal = $799,752

Grand Total All Awards = $799,752

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Efficacy of Continuous Glucose Monitoring Relative to Traditional Self-Monitoring of Blood Glucose in Non-Insulin Treated Adults with Poorly Controlled T2DM

Award Number: R01DK149293

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/01/2026

PERIOD OF PERFORMANCE END DATE: 06/30/2031

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