CONtiNuous glucosE Monitoring (CGM) in People wiTh Type 2 Diabetes Not on Insulin

NCT06601166 | Active Not Recruiting FDA Device

• 1 other identifier: PTL-1000299
• Study Type: interventional
• Target: 283
• Locations: 1 country
• Sites: 18

Brief Summary

This multi-center study is a 26-week randomized controlled trial (RCT) in which adults (≥18 years) with type 2 diabetes (T2D) not using insulin and managed in a primary-care setting will be randomly assigned 1:1 to either use of real-time continuous glucose monitoring (CGM) or routine care (RC) plus interval blinded CGM wear.

Conditions

Type 2 Diabetes

Keywords

Non-Insulin; NIT

Outcome Measures

Primary Outcomes (1)

• To assess the benefit on glycemic control and safety from baseline to week 26 using CGM versus RC.

  The primary outcome for the Primary RCT is HbA1c at 26 weeks adjusted for baseline (equivalent to change in HbA1c from baseline to 26 weeks).

  26 weeks

Secondary Outcomes (1)

• Outcome measures below will be tested for CGM accuracy to meet expected range.

  26 Weeks

Study Arms (2)

CGM user group

EXPERIMENTAL

Real-time CGM use

Device: CGM

Routine-care group

EXPERIMENTAL

Interval blinded CGM use and routine diabetes care

Device: CGM

Interventions

CGM DEVICE

Continuous Glucose Monitor

CGM user group; Routine-care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years old at the time of enrollment (date informed consent form signed is considered date of enrollment).
• Clinical diagnosis of type 2 diabetes based on investigator assessment of at least 6 months duration at time of enrollment that is being managed in a primary care setting by a primary care physician or nurse practitioner or physician assistant.
• Screening HbA1c ≥7.5% (Based on point-of care or local lab within 28 days of enrollment).
• Able to read and understand written English or Spanish.
• No personal real-time or intermittent scanned (Flash) CGM 6 months prior to enrollment.
• Stable medication regimen (medication classes) and dose (equivalent dose if medication has been changed within same medication class) for 1 month prior to enrollment.
• Willing to utilize the study devices and download Apps during the course of the study.
• Investigator believes that the participant has the cognitive capacity to provide informed consent, can successfully and safely use CGM, and is capable of adhering to the protocol and completing the study.
• a. This includes considering the potential impact of medical conditions known to be present including cardiovascular, liver, kidney disease, thyroid disease, adrenal disease, malignancies, vision difficulties, active proliferative retinopathy, skin or skin allergy condition, HIV, Hepatitis B or Hepatitis C infections; hemophilia; and other medical conditions; psychiatric conditions including eating disorders; drug or alcohol abuse.
• Participants capable of becoming pregnant must meet one of the following criteria:
• a. has a negative urine pregnancy test and agrees to use one of the accepted contraceptive regimens throughout the entire duration of the trial from screening until last follow-up visit. The following contraceptive measures are considered adequate: i. Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal).
• ii. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).
• iii. Placement of an intrauterine device or intrauterine hormone-releasing system.
• iv. Barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository).
• v. Has a vasectomized or sterile partner (where partner is sole partner of participant) and where vasectomy has been confirmed by medical assessment.

You may not qualify if:

• Use of insulin in the 12 months prior to screening or planning to initiate insulin during the next 12 months.
• Thyroid stimulating hormone (TSH) outside the laboratory's reference range (above or below).
• a. Baseline blinded CGM data collection can be initiated prior to the lab result being available but lab result must be available prior to randomization to verify eligibility.
• Concomitant disease or condition that in the opinion of the investigator may compromise patient safety including but not limited to; cystic fibrosis, severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition that would interfere with study related tasks or visits.
• Bariatric surgical procedure within the year prior to enrollment or plans for undergoing bariatric surgery during the study.
• On any medications, known to exacerbate glucose dysfunction (such as isotretinoin or corticosteroids) or certain psychotropics, within 30 days of screening visit.
• Current or planned use of hydroxyurea.
• Presence of a hemoglobinopathy or other condition that is expected to affect the measurement of HbA1c in the judgment of the investigator.
• Known severe allergy to medical grade adhesives or a serious skin condition that precludes use of the CGM.
• End stage renal disease currently managed by dialysis or anticipating initiating dialysis during the next 6 months, OR eGFR \<30.
• a. Baseline blinded CGM data collection can be initiated prior to the lab result being available but lab result must be available prior to randomization to verify eligibility.
• Current participation in another interventional study protocol or prior participation in an interventional study protocol in which the participant received active drug within the 90 days prior to screening.
• a. Note: Participants will not be excluded if enrolled in another observational trial, wherein the participant is in the follow-up phase and no tests/procedures impacting the participant's health are required. Participants participating in studies using only approved medications (that are not specifically excluded) or devices may qualify for this study.
• Previous randomization in this trial.

Sponsors & Collaborators

• DexCom, Inc.: lead
• Jaeb Center for Health Research: collaborator
• Scripps Research Digital Trial Center: collaborator
• Precision Data Health, Inc.: collaborator

Study Sites (18)

University of Colorado, Anschutz Medical Campus, Department of Family Medicine, Primary Care Diabetes Lab

Aurora, Colorado, 80045, United States

Location

Tekton Research

Denver, Colorado, 80238, United States

Location

East Coast Institute for Research

Lake City, Florida, 32055, United States

Location

Institute of Endocrinology, Diabetes, Health and Hormone

Stockbridge, Georgia, 30281, United States

Location

The South Bend Clinic

South Bend, Indiana, 46617, United States

Location

International Diabetes Center

Saint Louis Park, Minnesota, 55416, United States

Location

Jefferson City Medical Group

Jefferson City, Missouri, 65109, United States

Location

East Northport Medical Care

East Northport, New York, 11731, United States

Location

Cross Creek Medical Center

Fayetteville, North Carolina, 28304, United States

Location

Lucas Research

Morehead City, North Carolina, 28557, United States

Location

Alliance Medical Ministry

Raleigh, North Carolina, 27610, United States

Location

Centricity Research

Columbus, Ohio, 43213, United States

Location

Tekton Research

Moore, Oklahoma, 73160, United States

Location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Texas Tech University Health Sciences Center

Odessa, Texas, 79763, United States

Location

Cope Family Medicine Ogden Clinic

Bountiful, Utah, 84010, United States

Location

Riverside Family Medicine Residency

Newport News, Virginia, 23601, United States

Location

Mountain State Diabetes

Parkersburg, West Virginia, 26101, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 26-week RCT with a 1:1 randomization to intervention with CGM versus RC followed by a 26-week extension phase in which both groups use CGM.

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: September 19, 2024
• Study Start: August 15, 2024
• Primary Completion: May 13, 2026
• Study Completion (Estimated): December 16, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)