Digital Support for Reducing Salt Intake Among Patients With Diabetic Kidney Disease: Protocol for a Controlled Clinical Trial (StenoFOODApp)

March 16, 2026 updated by: Steno Diabetes Center Copenhagen

SBI 2024-2026 STENO FOOD CONCEPT

This study evaluates whether a digital patient education program can improve adherence to KDIGO 2022 dietary recommendations (low sodium and optimal protein intake) among patients with type 2 diabetes and chronic kidney disease (eGFR 30-59 ml/min).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study investigates the effect of a newly developed digital education platform, the StenoFOOD app, which provides personalized dietary guidance for individuals with type 2 diabetes and reduced kidney function. Participants are followed for six months, during which changes in sodium and protein intake are assessed, together with blood pressure and several exploratory outcomes.

Participants are assigned to one of two groups. The intervention group is recruited from Steno Diabetes Center Copenhagen and receives the app-based educational program, which includes dietary guidance and self-monitoring tools. The control group is recruited from Nordsjællands Hospital and receives standard care in the diabetes outpatient clinic. The primary outcome is the change in sodium intake, estimated from 24-hour urinary sodium excretion. Secondary outcomes include changes in protein intake, while exploratory outcomes cover blood pressure, albuminuria, potassium and phosphate excretion, food literacy, digital health literacy, and patient-reported measures.

Eligibility requires a diagnosis of type 2 diabetes, age between 18 and 74 years, a BMI below 35, and moderately reduced kidney function. Participants must also have stable medical treatment for at least three months and be able to read and understand Danish. Exclusion criteria include other types of diabetes, active cancer, certain gastrointestinal conditions, a vegan diet, or the use of sodium chloride tablets. Access to the digital platform is required for those assigned to the intervention arm.

The study is conducted at Steno Diabetes Center Copenhagen in Herlev and at Nordsjællands Hospital in Hillerød. It is sponsored by Steno Diabetes Center Copenhagen with collaboration from Rigshospitalet and Nordsjællands Hospital. The study has been approved by the Regional Ethics Committee in the Capital Region of Denmark.A total of 104 participants are expected to be enrolled.

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Captial Region of Denmark
      • Herlev, Captial Region of Denmark, Denmark, 2730
      • Hillerød, Captial Region of Denmark, Denmark, 3400
        • Recruiting
        • Nordsjællands Hospital, Hillerød
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Type 2 diabetes (ICD-10 DE11.x)
  • Age 18-74 years
  • BMI < 35 kg/m²
  • eGFR 30-59 ml/min and UACR > 30 mg/g
  • Stable medication for ≥3 months
  • Ability to read and understand Danish

Exclusion Criteria:

  • Type 1 diabetes or other diabetes types
  • Current vegan diet
  • Active cancer
  • Short bowel syndrome or celiac disease
  • Use of sodium chloride tablets
  • No access to digital platform (intervention group only)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard care
Standard care at diabetes outpatient clinic
Device: StenoFood App
Digital patient education program (app-based) with dietary guidance and self-monitoring tools
Other Names:
  • SBI-Steno_Food_Concept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sodium excretion between measurements at baseline and 6 months follow-up
Time Frame: 6 month
Sodium intake (g/day) will be estimated by the average of 2 collections of 24-hour urinary sodium at both baseline and follow-up
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in protein intake (g/kg/day) between baseline and follow-up measurements
Time Frame: 6 months
Protein intake will be estimated from the average of 2 collections of 24 hour urinary urea nitrogen at both baseline and follow-up
6 months
Change in Blood pressure between baseline and follow-up
Time Frame: 6 months
average of the two last blood preassure measurements out of three
6 months
Change in albumin, potassium and phosphate excretion between baseline and follow-up
Time Frame: 6 month
biochemical analysis of albumin, potassium, phosphate excreted in 2* 24 hour urine collections at baseline and follow-up
6 month
Change in dietary patterns between baseline and follow-up
Time Frame: 6 months
at both baseline and follow-up participants will fill in a three day food record as well as screeners for salt and protein intake
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes between baseline and follow-up in blood lipids
Time Frame: 6 months
At both baseline and follow-up participants and controls will have blood samples taken for biochemical analyses of blood lipids
6 months
Change in selfreported health, motivation, self efficcacy, food and healthy literacy baseline and follow-up
Time Frame: 6 months
at both baseline and follow-up participants will answer questionnaires on food literacy, health literacy, selfperceived health, motivation, selfefficacy and health literacy
6 months
Salt intake measured by spot-urine dipstick measurements
Time Frame: every month participants are invited to take three spoturine sample over 24 hrs and measure them with the Quantab chloride dipsticks
Feasibility study of dipstick measurements for self-monitoring of saltintake based on two morning and one evening measurements by the Quantab chloride dipsticks
every month participants are invited to take three spoturine sample over 24 hrs and measure them with the Quantab chloride dipsticks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steno Diabetes Center Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 20, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Steno Food Concept, H-25033125

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

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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