Digital support to reduce salt intake for people with type 2 diabetes and kidney disease
SBI 2024-2026 STENO FOOD CONCEPT
This project will test whether a smartphone app can help people with type 2 diabetes and moderately reduced kidney function eat less salt and follow kidney-friendly protein guidance over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Sponsor | Steno Diabetes Center Copenhagen Academic / other |
| Locations | 2 sites (Herlev, Captial Region of Denmark and 1 other locations) |
| Trial ID | NCT07485075 on ClinicalTrials.gov |
What this trial studies
This controlled clinical trial compares a personalized digital education program (the StenoFOOD app) to standard outpatient care for people with type 2 diabetes and moderately reduced kidney function. Participants are recruited from Steno Diabetes Center Copenhagen (intervention) and Nordsjællands Hospital (control) and are followed for six months. The primary outcome is change in sodium intake estimated from 24-hour urinary sodium; secondary outcomes track protein intake and exploratory outcomes include blood pressure, albuminuria, electrolyte excretion, food literacy, digital health literacy, and patient-reported measures. Eligibility focuses on adults with eGFR 30–59 ml/min and albuminuria, stable medical treatment, BMI <35, and the ability to read Danish.
Who should consider this trial
Good fit: Adults aged 18–74 with type 2 diabetes, moderately reduced kidney function (eGFR 30–59 ml/min) and albuminuria (UACR >30 mg/g), BMI <35, stable medication for ≥3 months, and who can read Danish are ideal candidates.
Not a fit: Patients with type 1 or other non–type 2 diabetes, eGFR outside 30–59 ml/min, current vegan diet, active cancer, short bowel syndrome or celiac disease, use of sodium tablets, or those unable to use the digital platform or read Danish are unlikely to benefit.
Why it matters
Potential benefit: If successful, the app could help patients reduce salt intake, improve blood pressure control, and support kidney-protective dietary habits.
How similar studies have performed: Previous digital dietary interventions have produced modest diet and blood pressure improvements in other populations, but using an app to deliver KDIGO-specific sodium and protein guidance in people with type 2 diabetes and CKD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Herlev, Captial Region of Denmark and 1 other locations
- Steno Diabetes Center Copenhagen, — Herlev, Captial Region of Denmark, Denmark (Recruiting)
- Nordsjællands Hospital, Hillerød — Hillerød, Captial Region of Denmark, Denmark (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.