Diabetes Type 2, Kidney Disease
Conditions
Keywords
Type 2 Diabetes, Chronic Kidney Disease, Digital Health, Dietary Intervention, KDIGO Guidelines
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).
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
DEVICEStenoFood App
Digital patient education program (app-based) with dietary guidance and self-monitoring tools
Sponsors
Steno Diabetes Center Copenhagen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in sodium excretion between measurements at baseline and 6 months follow-up | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in protein intake (g/kg/day) between baseline and follow-up measurements | 6 months | 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 | 6 months | average of the two last blood preassure measurements out of three |
| Change in albumin, potassium and phosphate excretion between baseline and follow-up | 6 month | 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 | 6 months | at both baseline and follow-up participants will fill in a three day food record as well as screeners for salt and protein intake |
Countries
Denmark
Outcome results
None listed