CONtiNuous glucosE monitoring (CGM) in people wiTh type 2 diabetes not on insulin: The CONNECT Study

Primary Objective

Assess the benefit on glycemic control and safety from baseline to Week 26 using CGM versus RC in adults with T2D on non-insulin therapies and with HbA1c > 7.5%.

Is This Study For You?

Let's Get Started!

Description

This multi-center study is a 26-week randomized controlled trial (RCT) in which adults (>17 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.

Details
Age
Adult
Eligibility
1. Age >18 years old at the time of enrollment (date informed consent form signed is considered date of enrollment). 2. 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. 3. Screening HbA1c ≥7.5% (Based on point-of care or local lab within 28 days of enrollment). 4. Able to read and understand written English or Spanish. 5. 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 6. 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.Inclusion Criteria: 1. Age >18 years old at the time of enrollment 2. 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. 3. Screening HbA1c ≥7.5% 4. Able to read and understand written English or Spanish. 5. No personal real-time or intermittent scanned (Flash) CGM 6 months prior to enrollment. 6. 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. 7. Willing to utilize the study devices and download Apps during the course of the study. 8. 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. 9. 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 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. Key Exclusion Criteria: 10. Use of insulin in the 12 months prior to screening or planning to initiate insulin during the next 12 months. 11. Thyroid stimulating hormone (TSH) outside the laboratory’s reference range (above or below). 12. 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. 13. Bariatric surgical procedure within the year prior to enrollment or plans for undergoing bariatric surgery during the study. 14. On any medications, known to exacerbate glucose dysfunction (such as isotretinoin or systemic corticosteroids) or certain psychotropics, within 30 days of screening visit. 15. Current or planned use of hydroxyurea. 16. Presence of a hemoglobinopathy or other condition that is expected to affect the measurement of HbA1c in the judgment of the investigator. 17. 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. 18. End stage renal disease currently managed by dialysis or anticipating initiating dialysis during the next 6 months, OR eGFR <30. 19. 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. 20. 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. 21. Previous randomization in this trial.
Locations

Anschutz Health and Wellness
Boulder Health Center
Lone Tree Medical Center
Outpatient CTRC
UCHealth Central Park Medical Center
UCHealth Family Practice - Westminster

Principal Investigator
Photograph of Erik Kramer

Erik Kramer

Study ID

Protocol Number: 24-1137

Is this Study for You?

Let's Get Started!

Not finding the right Study for you? Join ResearchMatch, a nation-wide registry connecting volunteers and researchers