About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Type 1 diabetes or other diabetes types
Current vegan diet
Active cancer
Short bowel syndrome or celiac disease
Trial design
Single group
Treatments tested in this trial
StenoFood App
DeviceDigital patient education program (app-based) with dietary guidance and self-monitoring tools
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
Change in Blood pressure between baseline and follow-up
average of the two last blood preassure measurements out of three
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
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
Other outcomes
Changes between baseline and follow-up in blood lipids
At both baseline and follow-up participants and controls will have blood samples taken for biochemical analyses of blood lipids
Change in selfreported health, motivation, self efficcacy, food and healthy literacy baseline and follow-up
at both baseline and follow-up participants will answer questionnaires on food literacy, health literacy, selfperceived health, motivation, selfefficacy and health literacy
Salt intake measured by spot-urine dipstick measurements
Feasibility study of dipstick measurements for self-monitoring of saltintake based on two morning and one evening measurements by the Quantab chloride dipsticks
Sponsors and contacts
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