- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04904718
Real World Evaluation of Advisor Pro in Clinical Practice
To assess the integration of the DreaMed Advisor Pro tool into a real-world clinical practice using both in person and virtual visits to assess benefits in glycemia, as measured by the glucose management indicator and other glucose metrics.
To determine acceptability of the DreaMed Advisor Pro tool both from a person with diabetes as well as a health care provider perspective.
To quantify the potential reimbursement potential that could be generated with use of the DreaMed Advisor Pro.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Participant with Type 1 diabetes
- Age ≥ 6 years to <30 years
Using Insulin infusion pump (CSII) therapy including those with low glucose suspend and predictive low glucose suspend features
- Insulin pump must not use automated insulin delivery (closed loop, artificial pancreas)
- Total daily dose of insulin must be greater than 0.5 units/kg/day
- Participants / parents are required to have minimum computer skills and access to a computer in order to upload their personal devices (Pump, BG meter etc) to Tidepool.
- Participants using Dexcom sensors will allow access to their account for the study duration
- Participants not using CGM must agree to test BG at least 4 times a day at appropriate intervals
- Participants / parents will have to have a smartphone (Apple or Android and Windows)
Exclusion Criteria:
- An episode of diabetic ketoacidosis within the month prior to study entry
- Any significant diseases / conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patient's safety,
- Current participation in any other interventional study
- Female subject who is pregnant or lactating or planning to become pregnant within the planned study duration
- Severe hypoglycemia within six months prior to enrollment as defined by the ADA and Endocrine Society
- Current use of the following medications: medications that are used to lower blood glucose such as Pramlintide, Metformin and GLP-1 analogs. Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study (Anticoagulant therapy e.g. Plavix, LMW heparin, Coumadin, Immunosuppressant therapy)
- Participants suffers from an eating disorder
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: DreaMed Advisor Pro tool used for insulin optimization
|
Advisor Pro software is a proprietary algorithm, designed to provide a comprehensive analysis of individual diabetes data consisting of glucose levels, insulin delivery history and meal consumption reported
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in glucose control with the use of DreaMed
Tidsramme: 6 months
|
Glucose mangement indicator (GMI) will be used to determine glucose control.
The GMI indicates the average A1C level that would be expected based on mean glucose measured in a large number of individuals with diabetes.
Mean glucose ideally is derived from at least 14 days of CGM data
|
6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jennifer Sherr, MD, PhD, Yale University
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2000029019
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med DreaMed Advisor Pro
-
Rabin Medical CenterThe Leona M. and Harry B. Helmsley Charitable Trust; DreaMed DiabetesRekruttering
-
DreaMed DiabetesAfsluttetDiabetes mellitus, type 1 | Insulinafhængig diabetes mellitusIsrael
-
Rabin Medical CenterAfsluttet
-
Rabin Medical CenterDreaMedAfsluttet
-
Rabin Medical CenterThe Leona M. and Harry B. Helmsley Charitable Trust; DreaMedAfsluttetType 1 diabetes mellitusForenede Stater, Tyskland, Israel, Slovenien
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University of Maryland, College ParkAfsluttetInformationsformidling | Evidensbaseret folkesundhedForenede Stater
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Philips HealthcareYale UniversityAfsluttetKliniske alarmerForenede Stater
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Abbott Medical DevicesAfsluttetVentrikulær takykardi | Vedvarende atrieflimrenCanada, Sydafrika, Danmark, Australien, Italien, Østrig, Frankrig, Tyskland, Holland, Portugal, Spanien
-
University of CalgaryAfsluttet
-
Rabin Medical CenterMedtronicAfsluttet