[Essai d'un dispositif qui n'est pas approuvé ou autorisé par la FDA américaine]
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Colorado
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Aurora, Colorado, États-Unis, 80045
- University of Colorado, Anschutz Medical Campus, Department of Family Medicine, Primary Care Diabetes Lab
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Denver, Colorado, États-Unis, 80238
- Tekton Research
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Florida
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Lake City, Florida, États-Unis, 32055
- East Coast Institute for Research
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Georgia
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Stockbridge, Georgia, États-Unis, 30281
- Institute of Endocrinology, Diabetes, Health and Hormone
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Indiana
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South Bend, Indiana, États-Unis, 46617
- The South Bend Clinic
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Minnesota
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Saint Louis Park, Minnesota, États-Unis, 55416
- International Diabetes Center
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Missouri
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Jefferson City, Missouri, États-Unis, 65109
- Jefferson City Medical Group
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New York
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East Northport, New York, États-Unis, 11731
- East Northport Medical Care
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North Carolina
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Fayetteville, North Carolina, États-Unis, 28304
- Cross Creek Medical Center
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Morehead City, North Carolina, États-Unis, 28557
- Lucas Research
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Raleigh, North Carolina, États-Unis, 27610
- Alliance Medical Ministry
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Ohio
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Columbus, Ohio, États-Unis, 43213
- Centricity Research
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Oklahoma
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Moore, Oklahoma, États-Unis, 73160
- Tekton Research
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Tennessee
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Elizabethton, Tennessee, États-Unis, 37643
- Medical Care-Avacare
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Texas
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Austin, Texas, États-Unis, 78705
- Tekton Research - Austin
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Lubbock, Texas, États-Unis, 79430
- Texas Tech University Health Sciences Center
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Odessa, Texas, États-Unis, 79763
- Texas Tech University Health Sciences Center
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Utah
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Bountiful, Utah, États-Unis, 84010
- Cope Family Medicine Ogden Clinic
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Roy, Utah, États-Unis, 84067
- Ogden Clinic Grand View
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Virginia
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Newport News, Virginia, États-Unis, 23601
- Riverside Family Medicine Residency
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West Virginia
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Parkersburg, West Virginia, États-Unis, 26101
- Mountain State Diabetes
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: CGM user group
Real-time CGM use
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Continuous Glucose Monitor
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Expérimental: Routine-care group
Interval blinded CGM use and routine diabetes care
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Continuous Glucose Monitor
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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To assess the benefit on glycemic control and safety from baseline to week 26 using CGM versus RC.
Délai: 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).
|
26 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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.
Délai: 26 Weeks
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26 Weeks
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PTL-1000299
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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