[Proef met een apparaat dat niet is goedgekeurd of goedgekeurd door de Amerikaanse FDA]
Studie Overzicht
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
- University of Colorado, Anschutz Medical Campus, Department of Family Medicine, Primary Care Diabetes Lab
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Denver, Colorado, Verenigde Staten, 80238
- Tekton Research
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Florida
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Lake City, Florida, Verenigde Staten, 32055
- East Coast Institute for Research
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Georgia
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Stockbridge, Georgia, Verenigde Staten, 30281
- Institute of Endocrinology, Diabetes, Health and Hormone
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Indiana
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South Bend, Indiana, Verenigde Staten, 46617
- The South Bend Clinic
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Minnesota
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Saint Louis Park, Minnesota, Verenigde Staten, 55416
- International Diabetes Center
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Missouri
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Jefferson City, Missouri, Verenigde Staten, 65109
- Jefferson City Medical Group
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New York
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East Northport, New York, Verenigde Staten, 11731
- East Northport Medical Care
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North Carolina
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Fayetteville, North Carolina, Verenigde Staten, 28304
- Cross Creek Medical Center
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Morehead City, North Carolina, Verenigde Staten, 28557
- Lucas Research
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Raleigh, North Carolina, Verenigde Staten, 27610
- Alliance Medical Ministry
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Ohio
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Columbus, Ohio, Verenigde Staten, 43213
- Centricity Research
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Oklahoma
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Moore, Oklahoma, Verenigde Staten, 73160
- Tekton Research
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Tennessee
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Elizabethton, Tennessee, Verenigde Staten, 37643
- Medical Care-Avacare
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Texas
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Austin, Texas, Verenigde Staten, 78705
- Tekton Research - Austin
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Lubbock, Texas, Verenigde Staten, 79430
- Texas Tech University Health Sciences Center
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Odessa, Texas, Verenigde Staten, 79763
- Texas Tech University Health Sciences Center
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Utah
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Bountiful, Utah, Verenigde Staten, 84010
- Cope Family Medicine Ogden Clinic
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Roy, Utah, Verenigde Staten, 84067
- Ogden Clinic Grand View
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Virginia
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Newport News, Virginia, Verenigde Staten, 23601
- Riverside Family Medicine Residency
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West Virginia
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Parkersburg, West Virginia, Verenigde Staten, 26101
- Mountain State Diabetes
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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 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.
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.
Key Exclusion Criteria:
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
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.
- 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, 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.
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.
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: CGM user group
Real-time CGM use
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Continuous Glucose Monitor
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Experimenteel: Routine-care group
Interval blinded CGM use and routine diabetes care
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Continuous Glucose Monitor
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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To assess the benefit on glycemic control and safety from baseline to week 26 using CGM versus RC.
Tijdsspanne: 26 weeks
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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).
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26 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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.
Tijdsspanne: 26 Weeks
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26 Weeks
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PTL-1000299
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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