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A Study to Evaluate the Effect and Benefit of Diabetes Management Decision Support Software for Blood Glucose Control

13. oktober 2016 oppdatert av: Rimidi Diabetes, Inc.

A Randomized, Controlled, Open-label, Multi-center Study to Evaluate the Effect and Benefit of Diabetes Management Decision Support Software for Blood Glucose Control

The benefit of drug therapy to persons with diabetes has been well established in clinical trials in terms of reducing cardiovascular risk, microvascular complications and mortality. However, treatment adherence and treatment effectiveness continue to be challenges in diabetes management.

Rimidi Diabetes has developed software algorithms to simulate the effect of anti-diabetic medications on an individual's glucose profile, allowing the clinician and their patient to visualize the anticipated outcome of a medical intervention. Use of this technology should allow for more targeted decision-making by the clinician and should facilitate a shared decision-making process with the PwD who is now privy to the thought process behind their medical management.

The proposed study is designed to test whether adding a decision support capability (Diabetes+Me Rx) that allows for modeling the anticipated effect of medication adjustments leads to improved glycemic control and a perceived benefit by healthcare providers and PwDs.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

  • Recruitment

    • Recruitment of persons with diabetes through a community diabetes management center according to inclusion and exclusion criteria below.
    • This is a three-armed study. Enrollees will be randomized to continue diabetes care with standard diabetes management in the Medication Management Clinic or the Intervention Group and compared to a matched cohort managed through their primary care physician (PCP) and standard of care.
    • The Intervention Group will be standard diabetes management in the Medication Management Clinic plus the use of Diabetes+Me with a connected glucometer.
    • Upon recruitment, PwD will be oriented to the Diabetes+Me application and instructed on how to complete a glucose profile and how to enter data into the application. Baseline hemoglobin A1C will be measured.
    • Enrollees will complete a brief survey of satisfaction with their diabetes management.

  • Study visits

    • The first study visit will be 2 weeks following enrollment.
    • Weight, number of medications, number of medication titrations, the presence of insulin and blood pressure will be measured at each study visit. Frequency of hypoglycemia in the preceding week will be documented at each visit. Adherence to medical prescription to be documented at each visit.
    • If the PwD has not entered data into Diabetes+Me this will be done at the beginning of each study visit.
    • At the first study visit, the HCP will review the glucose profile from the previous week, identify areas where the PwD is not meeting targets and model adjustments to their medications to achieve the desired anticipated effect. If indicated, a new prescription will be issued and the PwD instructed to collect a new glucose profile the week preceding the next visit.
    • The second study visit will occur 5 weeks following the initial visit. The HCP and PwD will review the glucose profile from the previous week, identify areas where the PwD is not meeting targets and model adjustments to their medications to achieve the desired anticipated effect. If indicated, a new prescription will be issued and the PwD instructed to collect a new glucose profile the week preceding the final visit.

The third and final study visit will occur 5 weeks following the second visit. The HCP and PwD will review the glucose profile from the previous week and identify if the PwD is meeting targets.

Studietype

Intervensjonell

Registrering (Forventet)

129

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Physician diagnosis of type 1 or type 2 diabetes
  • Glycated hemoglobin > 9% within 3 months
  • Age 18-80
  • Not currently managed by study clinicians

Exclusion Criteria:

  • Pregnant
  • Active substance abuse
  • Severe hearing or visual impairment
  • No internet or email access

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervention Group
Patient in standard diabetes management in the Medication Management Clinic plus the use of Diabetes+Me plus connected glucometer
Annen: Medication Management Clinic
referral to medication management clinic from primary care
Annen: Diabetes+Me plus connected glucometer
Use of software and medication modeling tool as add on to medication management standard of care
Aktiv komparator: Standard Diabetes Management
Patient in standard diabetes management in the Medication Management Clinic
Annen: Medication Management Clinic
referral to medication management clinic from primary care
Ingen inngripen: Primary Care
Matched cohort managed through their primary care physician (PCP) and standard of care.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Hemoglobin A1C
Tidsramme: change from baseline to 12 weeks
change from baseline to 12 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of hypoglycemic events per week
Tidsramme: change from 1st week to twelfth week
Decrease in frequency of hypoglycemia (# events per week
change from 1st week to twelfth week
Blood pressure
Tidsramme: change from baseline to 12 weeks
increase in percentage of patients with blood pressure in normotensive range
change from baseline to 12 weeks
BMI
Tidsramme: change from baseline to 12 weeks
decrease in BMI
change from baseline to 12 weeks
Healthcare provider satisfaction
Tidsramme: through study completion, an average of 1 year
healthcare provider satisfaction based on scoring of questionnaire
through study completion, an average of 1 year
A1C target attainment
Tidsramme: at 12 weeks
time to A1c goal attainment
at 12 weeks
Medication titrations needed
Tidsramme: 12 weeks
number of medication titrations over 12 week period needed to reach A1c goal
12 weeks
Patient satisfaction questionnaire
Tidsramme: through patient study completion, an average of 12 weeks
questionnaire addresses satisfaction with care and knowledge of diabetes self-management
through patient study completion, an average of 12 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Rimidi Diabetes, Inc.

Etterforskere

  • Hovedetterforsker: Michael Jardula, MD, Desert Oasis Healthcare

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2015

Primær fullføring (Forventet)

1. oktober 2016

Studiet fullført (Forventet)

1. november 2016

Datoer for studieregistrering

Først innsendt

17. august 2016

Først innsendt som oppfylte QC-kriteriene

13. oktober 2016

Først lagt ut (Anslag)

17. oktober 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

17. oktober 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. oktober 2016

Sist bekreftet

1. oktober 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RD-DOHC

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ubestemt

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