Type 2 Diabetes
Conditions
Keywords
Non-Insulin, NIT
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.
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.
Interventions
DEVICECGM
Continuous Glucose Monitor
Sponsors
DexCom, Inc.
Jaeb Center for Health Research
Scripps Research Digital Trial Center
Precision Data Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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. 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. 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. 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. 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. Key
Exclusion criteria
10. Use of insulin in the 12 months prior to screening or planning to initiate insulin during the next 12 months. a. Short-term use of insulin in an inpatient setting is not exclusionary 11. Thyroid stimulating hormone (TSH) outside the study central 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. 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, likely to exacerbate glucose dysfunction per investigator discretion (such as isotretinoin or systemic corticosteroids) or certain psychotropics, within 30 days of screening visit. 1. 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. 2. 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. 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 as determined by study central laboratory results. 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. 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. 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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the benefit on glycemic control and safety from baseline to week 26 using CGM versus RC. | 26 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 26 Weeks | * CGM-measured time in range 70-180 mg/dL (TIR) * CGM-measured mean glucose * CGM-measured time \>180 mg/dL * CGM-measured time \<54 mg/dL (non-inferiority, margin 0.5%) * CGM-measured time \<70 mg/dL (non-inferiority, margin 2.0%) * CGM-measured time \>250 mg/dL * CGM-measured time in tight range 70-140 mg/dL (TITR) * CGM-measured time \<70 mg/dL * Coefficient of variation |
Countries
United States
Outcome results
None listed