{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,16]],"date-time":"2026-05-16T03:09:28Z","timestamp":1778900968107,"version":"3.51.4"},"reference-count":41,"publisher":"MDPI AG","issue":"8","license":[{"start":{"date-parts":[[2018,8,4]],"date-time":"2018-08-04T00:00:00Z","timestamp":1533340800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Almased-Wellness-GmbH","award":["NA"],"award-info":[{"award-number":["NA"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Nutrients"],"abstract":"<jats:p>Background Formula diets can improve glycemic control or can even induce remission in type 2 diabetes. We hypothesized that especially an individualized intense meal replacement by a low-carbohydrate formula diet with accompanied self-monitoring of blood glucose (SMBG) contributes to long-term improvements in HbA1c, weight, and cardiometabolic risk factors in poorly controlled type 2 diabetes. Methods Type 2 diabetes patients were randomized into either a moderate group (M-group) with two meal replacements\/day (n = 160) or a stringent group (S-group) with three meal replacements\/day (n = 149) during the first week of intervention (1300\u20131500 kcal\/day). Subsequently, both groups reintroduced a low-carbohydrate lunch based on individual adaption due to SMBG in weeks 2\u20134. After week 4, breakfast was reintroduced until week 12. During the follow-up period, all of the participants were asked to continue replacing one meal per day until the 52-weeks follow-up. Additionally, an observational control group (n = 100) remained in routine care. Parameters were compared at baseline, after 12 and 52 weeks within and between all of the groups. Results 321 participants (83%) completed the acute meal replacement phase after 12 weeks and 279 participants (72%) the whole intervention after 52 weeks. Both intervention groups achieved improvements in HbA1c, fasting blood glucose, blood pressure, and weight (all p &lt; 0.001) within 12 weeks. However, these results were not significantly different between both of the intervention groups. The estimated treatment difference in HbA1c reduction was (mean (95% confidence interval [CI]) -0.10% with 95% CI [\u22120.40; 0.21] also (p &gt; 0.05) (S-group vs. M-group) not statistically different after 12 weeks. However, only the S-group showed a clinically relevant improvement in HbA1c of \u22120.81% [\u22121.06; \u22120.55] (p &lt; 0.001) after 52 weeks of follow-up, whereas HbA1c was not statistically different between the M- and control group. Conclusion Individualized meal replacement with SMBG demonstrated beneficial effects on HbA1c and cardiometabolic parameters in type 2 diabetes. Furthermore, the initiation of a weight loss program with one week of full meal replacement (three meals per day) resulted in a clinically relevant long-term HbA1c reduction, as compared to an observational control group that had standard care.<\/jats:p>","DOI":"10.3390\/nu10081022","type":"journal-article","created":{"date-parts":[[2018,8,7]],"date-time":"2018-08-07T03:44:18Z","timestamp":1533613458000},"page":"1022","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":42,"title":["Individualized Meal Replacement Therapy Improves Clinically Relevant Long-Term Glycemic Control in Poorly Controlled Type 2 Diabetes Patients"],"prefix":"10.3390","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4285-3127","authenticated-orcid":false,"given":"Kerstin","family":"Kempf","sequence":"first","affiliation":[{"name":"West-German Centre of Diabetes and Health, D\u00fcsseldorf Catholic Hospital Group, Hohensandweg 37, 40591 D\u00fcsseldorf, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2258-0582","authenticated-orcid":false,"given":"Martin","family":"R\u00f6hling","sequence":"additional","affiliation":[{"name":"West-German Centre of Diabetes and Health, D\u00fcsseldorf Catholic Hospital Group, Hohensandweg 37, 40591 D\u00fcsseldorf, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katja","family":"Niedermeier","sequence":"additional","affiliation":[{"name":"West-German Centre of Diabetes and Health, D\u00fcsseldorf Catholic Hospital Group, Hohensandweg 37, 40591 D\u00fcsseldorf, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Babette","family":"G\u00e4rtner","sequence":"additional","affiliation":[{"name":"West-German Centre of Diabetes and Health, D\u00fcsseldorf Catholic Hospital Group, Hohensandweg 37, 40591 D\u00fcsseldorf, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephan","family":"Martin","sequence":"additional","affiliation":[{"name":"West-German Centre of Diabetes and Health, D\u00fcsseldorf Catholic Hospital Group, Hohensandweg 37, 40591 D\u00fcsseldorf, Germany"},{"name":"Faculty of Medicine, Heinrich Heine University D\u00fcsseldorf, 40225 D\u00fcsseldorf, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2018,8,4]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"922","DOI":"10.2337\/dc13-2195","article-title":"Diabetes prevention in the real world: Effectiveness of pragmatic lifestyle interventions for the prevention of type 2 diabetes and of the impact of adherence to guideline recommendations: A systematic review and meta-analysis","volume":"37","author":"Dunkley","year":"2014","journal-title":"Diabetes Care"},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"Rise, M.B., Pellerud, A., Rygg, L.O., and Steinsbekk, A. 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