Actively Recruiting

Phase Not Applicable
Age: 18Years - 74Years
All Genders
ID07485075

Digital Support Using the StenoFOOD App to Reduce Salt Intake in Patients With Type 2 Diabetes and Chronic Kidney Disease

Led by Steno Diabetes Center Copenhagen · Updated on 2026-03-20

104

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate whether a digital patient education program can help people with type 2 diabetes and moderate chronic kidney disease follow dietary recommendations for low sodium and proper protein intake. The focus is on improving adherence to the 2022 KDIGO guidelines in patients with reduced kidney function (eGFR 30-59 ml/min). The study is sponsored by Steno Diabetes Center Copenhagen and involves a controlled clinical trial comparing digital support to standard care. Participants are divided into two groups. The intervention group receives access to the StenoFOOD app, which offers personalized dietary guidance and tools for self-monitoring. This group is recruited from Steno Diabetes Center Copenhagen. The control group receives usual care from the diabetes outpatient clinic at Nordsjællands Hospital. The study runs for six months, during which dietary changes and health measures are tracked. Throughout the study, researchers assess changes in sodium intake using 24-hour urine tests, protein intake, blood pressure, and other health markers such as albuminuria and electrolyte excretion. They also evaluate food literacy, digital health literacy, and patient-reported outcomes. Participants must be between 18 and 74 years old, have type 2 diabetes with moderate kidney impairment, and maintain stable medication for at least three months. The total participation period is six months, with ongoing monitoring and follow-up included.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 74Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of type 2 diabetes (ICD-10 DE11.x)
  • Age between 18 and 74 years
  • Body mass index (BMI) below 35 kg/m²
  • Estimated glomerular filtration rate (eGFR) between 30 and 59 ml/min and urine albumin-to-creatinine ratio (UACR) above 30 mg/g
  • Stable medication use for at least 3 months
  • Ability to read and understand Danish
Not Eligible

You will not qualify if you...

  • Diagnosis of 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 the digital platform (required for intervention group)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 6 months

Participants assigned to the intervention group use the StenoFOOD app, a digital education platform providing personalized dietary guidance and self-monitoring tools. Participants in the control group receive standard care at the diabetes outpatient clinic.

Baseline visit and follow-up visit at 6 months

Trial Site Locations

Total: 2 locations

1

Steno Diabetes Center Copenhagen,

Herlev, Captial Region of Denmark, Denmark, 2730

Actively Recruiting

2

Nordsjællands Hospital, Hillerød

Hillerød, Captial Region of Denmark, Denmark, 3400

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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Published Research Related To This Trial