A Study to Evaluate the Effect and Benefit of Diabetes Management Decision Support Software for Blood Glucose Control
13. oktober 2016 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
129
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention Group
Patient in standard diabetes management in the Medication Management Clinic plus the use of Diabetes+Me plus connected glucometer
|
referral to medication management clinic from primary care
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
|
referral to medication management clinic from primary care
|
|
Ingen indgriben: Primary Care
Matched cohort managed through their primary care physician (PCP) and standard of care.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Hemoglobin A1C
Tidsramme: change from baseline to 12 weeks
|
change from baseline to 12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Michael Jardula, MD, Desert Oasis Healthcare
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2015
Primær færdiggørelse (Forventet)
1. oktober 2016
Studieafslutning (Forventet)
1. november 2016
Datoer for studieregistrering
Først indsendt
17. august 2016
Først indsendt, der opfyldte QC-kriterier
13. oktober 2016
Først opslået (Skøn)
17. oktober 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. oktober 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. oktober 2016
Sidst verificeret
1. oktober 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RD-DOHC
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Uafklaret
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