Diabetes Type 2StenoFOODAppNCT07485075
Digital Support for Reducing Salt Intake Among Patients With Diabetic Kidney Disease: Protocol for a Controlled Clinical Trial
A study testing StenoFood App in people with Diabetes Type 2 and Kidney Disease, run by Steno Diabetes Center Copenhagen at 2 sites in Denmark.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Diabetes Type 2, Kidney Disease
- What is being tested?
- StenoFood App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 2 sitesDenmark
- Study dates
- 20 Mar 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Steno Diabetes Center Copenhagen,
Herlev, Captial Region of Denmark, 2730
Kirsten S Bjørnsbo, phd, 0045 20169134, kirsten.bjoernsbo@regionh.dk
Signe Lautrup-Nielsen, MSc, 0045 91172915, signe.lautrup-nielsen@regionh.dk
- Recruiting
Nordsjællands Hospital, Hillerød
Hillerød, Captial Region of Denmark, 3400
Eva Branner, Master of Public Health, 0045 51602696, eva.branner.01@regionh.dk
About this study
Official title: 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).
Read the 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.
- Conditions
- Diabetes Type 2, Kidney Disease
- Being tested
- StenoFood App
- Keywords
- Type 2 Diabetes, Chronic Kidney Disease, Digital Health, Dietary Intervention, KDIGO Guidelines
- Medical subject headings
- Diabetes Mellitus, Type 2, Kidney Diseases, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StenoFood AppDevice
Also called SBI-Steno_Food_Concept
Digital patient education program (app-based) with dietary guidance and self-monitoring tools
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Other | Standard care at diabetes outpatient clinic Receives: Device: StenoFood App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sodium excretion between measurements at baseline and 6 months follow-up
Sodium intake (g/day) will be estimated by the average of 2 collections of 24-hour urinary sodium at both baseline and follow-up
Measured: 6 month
Secondary outcomes (4)
Change in protein intake (g/kg/day) between baseline and follow-up measurements
Protein intake will be estimated from the average of 2 collections of 24 hour urinary urea nitrogen at both baseline and follow-up
Measured: 6 months
Change in Blood pressure between baseline and follow-up
average of the two last blood preassure measurements out of three
Measured: 6 months
Change in albumin, potassium and phosphate excretion between baseline and follow-up
biochemical analysis of albumin, potassium, phosphate excreted in 2* 24 hour urine collections at baseline and follow-up
Measured: 6 month
Change in dietary patterns between baseline and follow-up
at both baseline and follow-up participants will fill in a three day food record as well as screeners for salt and protein intake
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start20 Mar 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Allocation: Patients for the intervention group will be recruited from Steno Diabetes Center Copenhagen and will receive dietary guidance by StenoFood App(n=52) Patients for the control group will be recruited from Nordsjællands Hospital and receive standard care (n=52) \- Primary Purpose: Health Education
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485075
- Sponsor's protocol ID
- Steno Food Concept, H-25033125
- Acronym
- StenoFOODApp
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36184219
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SBI 2024-2026 STENO FOOD CONCEPT
- ClinicalTrials.gov ID
- NCT07485075
- Acronym / sponsor ID
- StenoFOODApp / Steno Food Concept, H-25033125
- Conditions
- Diabetes Type 2, Kidney Disease
- Keywords
- Type 2 Diabetes, Chronic Kidney Disease, Digital Health, Dietary Intervention, KDIGO Guidelines
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Allocation: Patients for the intervention group will be recruited from Steno Diabetes Center Copenhagen and will receive dietary guidance by StenoFood App(n=52) Patients for the control group will be recruited from Nordsjællands Hospital and receive standard care (n=52) - Primary Purpose: Health Education
| Arm | Type | Receives |
|---|---|---|
| Standard care | Other | Device: StenoFood AppStandard care at diabetes outpatient clinic |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Type 1 diabetes or other diabetes types
- Current vegan diet
- Active cancer
- Short bowel syndrome or celiac disease
- Use of sodium chloride tablets
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StenoFood AppAlso: SBI-Steno_Food_ConceptDigital patient education program (app-based) with dietary guidance and self-monitoring tools | Device | Standard care |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Background: PubMed 36184219Alhashimi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StenoFood App in people with Diabetes Type 2 and Kidney Disease, run by Steno Diabetes Center Copenhagen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sodium excretion between measurements at baseline and 6 months follow-up (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07485075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.