Diuretic Tuner Clinical Decision Support

Diuretic Tuner Clinical Decision Support Mobile Device Application for Diuretic Titration in Hypervolemic States

This purpose of this study is to determine the effectiveness of a mobile phone application in helping to control body swelling in patients with kidney problems. The application will help in the day to day adjustments in diuretic medication dosing.

Participants in this study will have an application loaded on to their mobile phone by the study team and be taught how to use it over a 2 hour visit. Participants will need to check their blood pressure and weight daily and enter this information into the mobile phone application every day. Participants will need to follow daily instructions in their medication dosing provided by the application. There will be periodic blood testing. This will happen at 2 weeks, 90 days, and up to 4 other times if necessary. At the end of the study there is a 2 hour study visit during which participants will answer a survey. The total length of the study is 90 days.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases; Edema; Nephrotic Syndrome; Hypervolemia
• Intervention / Treatment: Device: Diuretic Tuner

Detailed Description

Study Population: 30 subjects with signs of hypervolemia and either nephrotic syndrome or chronic kidney disease 4 to 5.

Study Intervention: This is a nonrandomized, uncontrolled trial. The Diuretic Tuner mobile device application will be deployed in the care of hypervolemic subjects as defined in the study population. The Diuretic Tuner will integrate each subject's estimated dry weight and starting diuretic dose (both defined by healthcare provider) with daily weights and blood pressures to provide individualized guidance to the subject in day-to-day adjustments to his or her diuretic regimen. In addition, the application will generate a diary of daily weights, blood pressures, fluid intake, and medication compliance. There will be no control arm as this first phase is to test feasibility/safety.

Study Outcome Measures: The primary outcomes of interest will focus on the achievement of the provider-defined estimated dry weight (both the time to achieving this target as well as the subsequent stability in weights around this target). Secondary outcomes of interest include safety metrics (3-month hospitalization rates, rates of hypokalemia, and rates of acute kidney injury) and tool usability (assessed through surveys evaluating ease of comprehension and satisfaction).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kamalanathan K Sambandam, M.D.; Phone Number: 214-645-6190; Email: ksambandam@utsouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern
      • Contact: Kamalanathan K Sambandam; Phone Number: 469-441-7181; Email: ksambandam@utsouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The presence of nephrotic range proteinuria (> 3 g/d proteinuria by 24hr urine protein, 24hr urine albumin, spot urine protein/creatinine ratio, or spot urine albumin/creatinine ratio) or stage 4 or 5 chronic kidney disease (estimated glomerular filtration rate < 30 mL/min/1.73 m2 by Modification of Diet in Renal Disease equation) PLUS
• Clinical signs of hypervolemia present (lower extremity edema, ascites, or pleural effusions) with an estimated dry weight (defined as edema-free weight without orthostatic hypotension) 5 lbs less than enrollment body weight

Exclusion Criteria:

• Weight < 100 lbs or > 300 lbs.
• Autonomic insufficiency resulting in orthostatic hypotension at screening
• Hypokalemia at enrollment (defined as serum potassium < 3.5 mmol/L)
• Moderate to severe hyponatremia at enrollment (defined as serum sodium < 130 mmol/L)
• Serum creatinine > 6 mg/dL or > 1.5 times baseline
• Patients who are unable or unwilling to measure their home blood pressures and weights
• Patients without a working phone number and smart phone device
• Expectation that the patient will require dialysis initiation within < 3 months
• Expected lifespan of < 6 months
• The presence of a medical condition that would interfere with effectively using the Diuretic Tuner (dementia, illiteracy, or blindness)
• Pregnant patients
• Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diuretic Tuner users; The Diuretic Tuner is a mobile device application that integrates a patient's estimated dry weight and starting diuretic dose (both defined by a healthcare provider) with daily weights and blood pressures to provide individualized guidance to the patient in day-to-day adjustments to his or her diuretic regimen. In addition, the application generates a diary of daily weights, blood pressures, fluid intake, and medication compliance.

Device: Diuretic Tuner; Mobile device application for diuretic dose titration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean time to the attainment of dry weight	Mean time in days to the attainment of the provider-specified estimated dry weight	90 days
90 day weight variability	90 day weight variability around the target dry weight, as assessed by standard deviation	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite rate of hospitalization, hypokalemia, or acute renal insufficiency	90 day adverse event rate for the composite outcome including hospitalization for volume-related complications (hypervolemia, hypovolemia, or electrolyte disturbance), hypokalemia (serum potassium < 3.5 mmol/L), or acute renal insufficiency (serum creatinine ≥ 2 times baseline or > 6 mg/dL)	90 days
Diuretic Tuner usability assessed by user survey	Diuretic tuner usability (measured by Likert scale survey administered to each subject at the end of 90 days)	90 days

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 14, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 14, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Chemically-Induced Disorders; Renal Insufficiency; Water-Electrolyte Imbalance; Poisoning; Nephrosis; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Renal Insufficiency, Chronic; Edema; Nephrotic Syndrome; Water Intoxication; Physiological Effects of Drugs; Natriuretic Agents; Diuretics
• Other Study ID Numbers: STU 2020-1124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No