Digital Support for Reducing Salt Intake Among Patients With Diabetic Kidney Disease: Protocol for a Controlled Clinical Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-74
SponsorSteno Diabetes Center Copenhagen

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • StenoFood App

    Device

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

Treatment groups

104 Participants
are divided into 1 treatment group
Group A: Standard careOther 1 intervention

Trial outcomes

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

Time frame
6 month

Secondary outcomes

1

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

Time frame
6 months
2

Change in Blood pressure between baseline and follow-up

average of the two last blood preassure measurements out of three

Time frame
6 months
3

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

Time frame
6 month
4

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

Time frame
6 months

Other outcomes

1

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

Time frame
6 months
2

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

Time frame
6 months
3

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

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

Sponsors and contacts

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