NCT07485075

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Mar 2026Dec 2027

First Submitted

Initial submission to the registry

March 16, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 20, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

March 16, 2026

Last Update Submit

March 16, 2026

Conditions

Diabetes Type 2Kidney Disease

Keywords

Type 2 Diabetes, Chronic Kidney Disease, Digital Health, Dietary Intervention, KDIGO Guidelines

Outcome Measures

Primary Outcomes (1)

  • 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

    6 month

Secondary Outcomes (4)

  • Change in protein intake (g/kg/day) between baseline and follow-up measurements

    6 months

  • Change in Blood pressure between baseline and follow-up

    6 months

  • Change in albumin, potassium and phosphate excretion between baseline and follow-up

    6 month

  • Change in dietary patterns between baseline and follow-up

    6 months

Other Outcomes (3)

  • Changes between baseline and follow-up in blood lipids

    6 months

  • Change in selfreported health, motivation, self efficcacy, food and healthy literacy baseline and follow-up

    6 months

  • Salt intake measured by spot-urine dipstick measurements

    every month participants are invited to take three spoturine sample over 24 hrs and measure them with the Quantab chloride dipsticks

Study Arms (1)

Standard care

OTHER

Standard care at diabetes outpatient clinic

Device: StenoFood App

Interventions

StenoFood AppDEVICE

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

Also known as: SBI-Steno_Food_Concept
Standard care

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Steno Diabetes Center Copenhagen,

Herlev, Captial Region of Denmark, 2730, Denmark

RECRUITING

Nordsjællands Hospital, Hillerød

Hillerød, Captial Region of Denmark, 3400, Denmark

RECRUITING

Related Publications (1)

  • 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: 36184219BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Kidney DiseasesRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal InsufficiencyChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 20, 2026

Study Start

March 20, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)