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NCT Number: NCT07485075

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

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).

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Key information

Conditions

Diabetes Type 2 Chronic Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Disease Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center Copenhagen,, Herlev, Captial Region of Denmark, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

StenoFood App

Device

Digital patient education program (app-based) with dietary guidance and self-monitoring tools

Other names: SBI-Steno_Food_Concept

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Change in Blood pressure between baseline and follow-up

    Time frame: 6 months

    average of the two last blood preassure measurements out of three

  3. 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

  4. 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

Other outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Registry information

Official study title

SBI 2024-2026 STENO FOOD CONCEPT

Acronym: StenoFOODApp

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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