Digital Support for Reducing Salt Intake Among Patients With Diabetic Kidney Disease: Protocol for a Controlled Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: StenoFood App.
- Who it may be relevant to
- Registry conditions: Diabetes Type 2, Kidney Disease. Basic parameters: 18 years — 74 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
SBI 2024-2026 STENO FOOD CONCEPT
Overview
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).
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.
Interventions
- Device StenoFood App
Digital patient education program (app-based) with dietary guidance and self-monitoring tools
Primary outcome measures
- Change in sodium excretion between measurements at baseline and 6 months follow-up [Time frame: 6 month]
Secondary outcome measures (4)
- Change in protein intake (g/kg/day) between baseline and follow-up measurements [Time frame: 6 months]
- Change in Blood pressure between baseline and follow-up [Time frame: 6 months]
- Change in albumin, potassium and phosphate excretion between baseline and follow-up [Time frame: 6 month]
- Change in dietary patterns between baseline and follow-up [Time frame: 6 months]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Denmark · 2 centers
- Steno Diabetes Center Copenhagen, — Herlev
- Nordsjællands Hospital, Hillerød — Hillerød
Publications
- Alhashimi L, Cordwin DJ, Dandu C, Hummel SL, Dorsch MP. Patient self-assessment of urine dipsticks to estimate sodium intake in patients with hypertension. Clin Nutr ESPEN. 2022 Oct;51:295-300. doi: 10.1016/j.clnesp.2022.08.011. Epub 2022 Aug 12. PMID 36184219
Identifiers
NCT: NCT07485075 · Steno Food Concept, H-25033125