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Type 2 DiabetesNCT06601166

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

A study testing CGM in people with Type 2 Diabetes, run by DexCom, Inc. at 21 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
CGM
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
283 participants
Where
21 sitesUnited States
Study dates
15 Aug 2024to 16 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Note: Previous wear of a professional CGM will not be exclusionary
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  • Stable medication regimen (medication classes) and dose (equivalent dose if medication has been changed within same medication class) for any glucose lowering or weight loss medications for 30 days 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.
  • 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:
  • 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).
  • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).
  • Placement of an intrauterine device or intrauterine hormone-releasing system.
  • Barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository).
  • Has a vasectomized or sterile partner (where partner is sole partner of participant) and where vasectomy has been confirmed by medical assessment.
  • 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.

Who cannot join

  • Use of insulin in the 12 months prior to screening or planning to initiate insulin during the next 12 months.
  • Short-term use of insulin in an inpatient setting is not exclusionary
  • Thyroid stimulating hormone (TSH) outside the study central laboratory's reference range (above or below).
  • 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.
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  • On any medications, likely to exacerbate glucose dysfunction per investigator discretion (such as isotretinoin or systemic corticosteroids) or certain psychotropics, within 30 days of screening visit.
  • Initiation or dose changes of such medications should be avoided prior to randomization during collection of baseline blinded CGM data unless indicated for safety reasons.
  • Chronic use of such medications at a stable dose for at least 30 days may be acceptable if in the investigator's judgment, the impact of their effect on glucose levels is expected to be minimal.
  • 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 (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, or dermatitis herpetiformis) 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 as determined by study central laboratory results.
  • 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.
  • 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.
  • The participant, immediate family member(s), and/or person(s) living within the household work for Dexcom, Medtronic, Glysens Inc., Abbott Laboratories, Roche, Senseonics, Waveform, Ascensia Diabetes Care, POCTech, or Insulet; immediate relation to study staff.
  • Previous randomization in this trial.

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

United States21 sites

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

    Aurora, Colorado, 80045

  • Tekton Research - Austin

    Austin, Texas, 78705

  • Cope Family Medicine Ogden Clinic

    Bountiful, Utah, 84010

  • Centricity Research

    Columbus, Ohio, 43213

  • Tekton Research

    Denver, Colorado, 80238

  • East Northport Medical Care

    East Northport, New York, 11731

  • Medical Care-Avacare

    Elizabethton, Tennessee, 37643

  • Cross Creek Medical Center

    Fayetteville, North Carolina, 28304

  • Jefferson City Medical Group

    Jefferson City, Missouri, 65109

  • East Coast Institute for Research

    Lake City, Florida, 32055

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79430

  • Tekton Research

    Moore, Oklahoma, 73160

  • Lucas Research

    Morehead City, North Carolina, 28557

  • Riverside Family Medicine Residency

    Newport News, Virginia, 23601

  • Texas Tech University Health Sciences Center

    Odessa, Texas, 79763

  • Mountain State Diabetes

    Parkersburg, West Virginia, 26101

  • Alliance Medical Ministry

    Raleigh, North Carolina, 27610

  • Ogden Clinic Grand View

    Roy, Utah, 84067

  • International Diabetes Center

    Saint Louis Park, Minnesota, 55416

  • The South Bend Clinic

    South Bend, Indiana, 46617

  • Institute of Endocrinology, Diabetes, Health and Hormone

    Stockbridge, Georgia, 30281

Other trials in United States

About this study

Official title: CONtiNuous glucosE Monitoring (CGM) in People wiTh Type 2 Diabetes Not on Insulin: The CONNECT Study

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.

Read the detailed description

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. The Primary RCT will be followed by a 26-week extension phase in which both groups will use CGM.

Conditions
Type 2 Diabetes
Being tested
CGM
Keywords
Non-Insulin, NIT
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CGMDevice

    Continuous Glucose Monitor

Study groups in NCT06601166
Study groupRoleWhat they receive
CGM user groupExperimentalReal-time CGM use
Receives: Device: CGM
Routine-care groupExperimentalInterval blinded CGM use and routine diabetes care
Receives: Device: CGM

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 26 weeks

Secondary outcomes (1)

  1. Following key secondary efficacy endpoints will be tested in the following hierarchy to control for the type 1 error (assuming the analysis of the primary endpoint is statistically significant). Testing will be for superiority unless otherwise specified.

    • CGM-measured time in range 70-180 mg/dL (TIR)
    • CGM-measured mean glucose
    • CGM-measured time \&gt;180 mg/dL
    • CGM-measured time \&lt;54 mg/dL (non-inferiority, margin 0.5%)
    • CGM-measured time \&lt;70 mg/dL (non-inferiority, margin 2.0%)
    • CGM-measured time \&gt;250 mg/dL
    • CGM-measured time in tight range 70-140 mg/dL (TITR)
    • CGM-measured time \&lt;70 mg/dL
    • Coefficient of variation

    Measured: 26 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start15 Aug 2024
  3. Primary completion13 May 2026
  4. Study completion16 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
283 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06601166
Sponsor's protocol ID
PTL-1000299
Status last verified
Aug 2026
First submitted
14 Aug 2024
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Oser TK, Martens T, Ruedy KJ, Bergford S, Calhoun P, Chang KL, Kramer ES, Klug BA, Anderson RL, Cook BR, Pickering D, Ortega M, Peterson B, Davidson L, Schmid R, Desai ND, Burkett E, Haynes JL, Herman A, Topiwala SM, Bailey R, Oser SM, Cadet NN, Johnson ML, Elkind-Hirsch KE, Beck SE, Castle JR, Beck RW; CONNECT Study Group. Continuous Glucose Monitoring in Non-Insulin-Treated Type 2 Diabetes. N Engl J Med. 2026 Oct 14. doi: 10.1056/NEJMoa2608571. Online ahead of print.

    PubMed 42878622

Questions about this trial

What is this clinical trial studying?

A study testing CGM in people with Type 2 Diabetes, run by DexCom, Inc. at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the benefit on glycemic control and safety from baseline to week 26 using CGM versus RC. (time frame: 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06601166, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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