Applying a digital, personalized, low-glycemic nutritional program in patients with a non-insulin treated type 2 diabetes mellitusA one-armed pilot study over a period of 12 weeks

Not Applicable

• Conditions: E11; Type 2 diabetes mellitus

• Registration Number: DRKS00026008
• Lead Sponsor: Perfood GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-04
• Study Completion: 2023-12-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Type 2 diabetes mellitus E11, - without insulin treatment based on at least two of the following tests:

o HbA1c = 6.5% (48 mmol / mol)
o Fasting plasma glucose = 126 mg / dl (7 mmol / l)
o OGTT-2 hours = 200 mg / dl (11.1 mmol / l)
o Occasional plasma glucose = 200 mg / dL (11.1 mmol / L) with typical diabetes-related symptoms

- HbA1c = 6.5% (48 mmol / mol) at the last clinical routine check (within the last 12 months);

- Treatment with one of the following options (unchanged since at least 3 months)

1. Lifestyle modification only
2. metformin
3. SGLT-2 inhibition
4. GLP-1 analogs
5. DPP4 inhibition
6. any combination of drugs from 2 to 5.

- Body Mass Index (BMI)> 27 and = 40 kg / m2;

- Written declaration of consent;

- Good understanding of written and spoken German;

- Use of an Android smartphone (version 5.1 or higher) or iOS smartphones (version 13.0 or higher);

- Intellectual capacity and willingness to change Lifestyle according to the dietary recommendations

Exclusion Criteria

- Use of a Perfood GmbH product with a glucose monitoring test phase within the past 24 months;

- Antibiotic treatment (systemic, longer than 1 day) within the last 3 months;

- Pregnancy, breastfeeding or active desire to have children (acc. patient information);

- Eating disorder, e.g. binge eating, bulimia, anorexia nervosa;

- Alcohol or drug abuse;

- Current and planned participation in another clinical study;

- Current insulin treatment;

- HbA1c = 8.5% (70 mmol / mol);

- Weight change of = 5% of the initial body weight within the last 3 months;

- last eGFR <30 ml / min / 1.73 m2;

- Known tumor disease (exception: remission after treatment for at least 2 years);

- Myocardial infarction within the last 6 months;

- Severe heart failure defined as equivalent to class 3 the New York Heart Association (NYHA);

- Current treatment with anti-obesity drugs

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. relative change in body weight;<br>2. absolute change in HbA1c

Secondary Outcome Measures

Name	Time	Method
1. Absolute change in fasting glucose;<br><br>2. Absolute change in the oGTT-2-hour value;<br><br>3. HbA1c status (normal with HbA1c <6.5% or 48 mmol / mol);<br><br>4. Time in range: relative change in the CGM time with glucose values ??in the therapeutic target range of 70 to 180 mg / dl;<br><br>5. Relative change in insulin resistance (HOMA-IR)