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

Dexcom

Status

Active, not recruiting

Conditions

Type 2 Diabetes

Treatments

Device: CGM

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06601166

PTL-1000299

Details and patient eligibility

About

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.

Full description

Enrollment

283 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

a. Note: Previous wear of a professional CGM will not be exclusionary
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.

vi. Exercises true sexual abstinence. Sexual abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.

or b. Participant is of non-childbearing potential due to menopause with at least one year since last menses or a medical condition confirmed by the investigator."

Exclusion criteria

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.