Publications

Our Publications

The communication of our research results is a major concern for us. That is the reason why you will find a detailed overview of our publications.

To the complete list of publications since 2001

Our Study Results

Accuracy of blood glucose meters
Accuracy of CGM systems
Other CGM studies
Insulin pumps
Usability Testing
1. Beltzer A, Kölle J, Gil Miró M, Pleus S, Krauss C, Haug C, Safary E, Vetter B, Freckmann G. Benefits of Usability Evaluation in the Development Process of Diabetes Technologies Using the Example of a Continuous Glucose Monitoring System Prototype.","J Diabetes Sci Technol. 2024 Mar 13:19322968241238146. doi: 10.1177/19322968241238146. Online ahead of print.
Other studies
1. Pors A, Korzeniowska B, Rasmussen MT, Lorenzen CV, Rasmussen KG, Inglev R, Philipps A, Zschornack E, Freckmann G, Weber A, Hepp KD. Calibration and performance of a Raman-based device for non-invasive glucose monitoring in type 2 diabetes. Sci Rep. 2025 Mar 25;15(1):10226.
2. Eichenlaub M, Gil Miro M, Pleus S, Waldenmaier D, Wiesner T, Schlüter S, Freckmann G. Vorsicht bei der Benutzung von Smartwatches mit angeblicher Glukosemessfunktion. Diabetes Stoffw Herz 2024; 33: 102 –104
3. Kannenberg S, Voggel J, Thieme N, Witt O, Pethahn KL, Schütt M, Sina C, Freckmann G, Schröder T. Unlocking Potential: Personalized Lifestyle Therapy for Type 2 Diabetes Through a Predictive Algorithm-Driven Digital Therapeutic. J Diabetes Sci Technol. 2024 Jul 30:19322968241266821. doi: 10.1177/19322968241266821. Epub ahead of print.
4. Snel T, Reinhardt S, Koenig H, Pleus S, Freckmann G. An SMS-Guided Basal Insulin Titration in People with Type 2 Diabetes New on Insulin. Diabetes Ther. 2024 Nov;15(11):2429-2441. doi: 10.1007/s13300-024-01650-2. Epub 2024 Sep 30.
5. Pleus S, Beil A, Baumstark A, Haug C, Freckmann G. Plasma glucose concentrations in different sampling tubes measured on different glucose analysers. Exp Clin Endocrinol Diabetes. 2024 May;132(5):260-266.
6. Jendrike N, Freckmann G, Krauß C, Mende J, Waldenmaier D, Heinemann L, Trippe ZA, Websky S. Evaluation of the Tolerability of a Steel Needle and an Adhesive for a Patch Pump. J Diabetes Sci Technol. 2023 Jul(17(4):1123-1125
7. Pleus S, Schauer S, Baumstark A, Beil A, Jendrike N, Link M, Zschornack E, Beltzer A, Haug C, Freckmann G. Differences in venous, capillary and interstitial glucose concentrations in individuals without diabetes after glucose load. J Med Lab. 2023 Apr 19: doi.org/10.1515/labmed -2023-0013.
8. Pors A, Rasmussen KG, Inglev R, Jendrike N, Philipps A, Ranjan AG, Vestergaard V, Henriksen JE, Norgaard K, Freckmann G, Hepp KD, Gerstenberg MC, Weber A. Accurate Post-Calibration Predictions for Noninvasive Glucose Measurements in People Using Confocal Raman Spectroscopy. ACS Sens. 2023 Mar 6. Doi: 10.1021/acssensors.2c02756.
9. Hermanns N, Ehrmann D, Finke-Gröne K, Roos T, Freckmann G, Kulzer B. Evaluation of a Digital Health Tool for Titration of Basal Insulin in People With Type 2 Diabetes: Rationale and Design of a Randomized Controlled Trial. J Diabetes Sci Technol. 2023 Jul;18(4):946-955.
10. Waldenmaier D, Buck S, Pleus S, Beltzer A, Schauer S, Link M, Zschornack E, Jendrike N, Haug C, Freckmann G. Meal responses in people without diabetes using continuous glucose monitoring. Diabetes Stoffw Herz 2023; 31:61–68.
11. Pleus S, Freckmann G, Baumstark A, Haug C. Stability of Glucose Concentrations in Frozen Plasma. J Diabetes Sci Technol. 2022 Sep;16(5):1096-1100.
12. Buck S, Krauss C, Waldenmaier D, Liebing C, Jendrike N, Högel J, Pfeiffer BM, Haug C, Freckmann G. Evaluation of Meal Carbohydrate Counting Errors in Patients with Type 1 Diabetes. Exp Clin Endocrinol Diabetes. 2022 Jul;130(7):475-483.
13. Baumstark A, Pleus S, Hartwig M, Freckmann G. Evaluation of Trueness and Precision of a Bench-Top Laboratory Glucose Analyzer Using Reference Materials. J Diabetes Sci Technol. 2022 May;16(3):751-755.
14. Pleus S, Schauer S, Jendrike N, Zschornack E, Link M, Hepp KD, Haug C, Freckmann G. Proof of Concept for a New Raman-Based Prototype for Noninvasive Glucose Monitoring. J Diabetes Sci Technol. 2021 Jan;15(1):11-18.
15. Kulzer B, Anderten H, Borck A, Freckmann G. Verbesserung der Blutzuckereinstellung und des Empowerments bei Patienten mit Diabetes durch Selbstkontrolle des HbA1-Werts - eine nicht interventionelle Studie. Diab Stoffw Herz 2020;29(1): 9-14.

More Publications

Review articles
Practical recommendations in which we were involved
1. Pleus S, Tytko A, Landgraf R, Heinemann L, Werner C, Müller-Wieland D, Ziegler AG, Müller UA, Freckmann G, Kleinwechter H, Schleicher E, Nauck M, Petersmann A. Definition, Classification, Diagnosis and Differential Diagnosis of Diabetes Mellitus: Update 2023. Exp Clin Endocrinol Diabetes. 2024 Mar;132(3):112-124.
2. Schlüter S, Deiss D, Gehr B, Lange K, von Sengbusch S, Thomas A, Ziegler R, Freckmann G. Glucose Monitoring and Control Testing in Patients with Type 1 or Type 2 diabetes. Exp Clin Endocrinol Diabetes. 2024 Jun;132(6):298-315.
3. Pleus S, Tytko A, Landgraf R, Heinemann L, Werner C, Müller-Wieland D, Ziegler AG, Müller UA, Freckmann G, Kleinwechter H, Schleicher E, Nauck M, Petersmann A. Definition, Klassifikation, Diagnostik und Differenzialdiagnostik des Diabetes mellitus: Update 2023. Diabetologie und Stoffwechsel 2023; 18(S 02):S100-S113.
4. Schlüter S, Deiss D, Gehr B, Lange K, von Sengbusch S, Thomas A, Ziegler R, Freckmann G. Glukosemessung und -kontrolle bei Patienten mit Typ-1- oder Typ-2-Diabetes. Diabetologie und Stoffwechsel 2023;18(S 02): S114-S135.
5. Pleus S, Tytko A, Landgraf R, Heinemann L, Werner C, Müller-Wieland D, Ziegler AG, Müller UA, Freckmann G, Kleinwechter H, Schleicher E, Nauck M, Petersmann A. Definition, Klassifikation, Diagnostik und Differenzialdiagnostik des Diabetes mellitus: Update 2023. Diabetologie und Stoffwechsel 2023; 18(S 02):S100-S113.
6. Schlüter S, Deiss D, Gehr B, Lange K, von Sengbusch S, Thomas A, Ziegler R, Freckmann G. Glukosemessung und -kontrolle bei Patienten mit Typ-1- oder Typ-2-Diabetes. Diabetologie 2022;17(Suppl 2):S111-S132.
7. Landgraf R, Heinemann L, Schleicher E, Gerdes C, Petersmann A, Müller-Wieland D, Müller U, Freckmann G, Thaler M, Ziegler A, Kleinwechter H, Nauck M. Definition, Klassifikation, Diagnostik und Differenzialdiagnostik des Diabetes mellitus: Update 2022. Diabetologie 2022;17(Suppl 2):S98-S110.
Standardization of CGM (IFCC WG-CGM)
Additional
1. Pleus S, Buck S, Heinemann L, Freckmann G. Glukosemessung in der Diabetestherapie. Diabetologie (2025). https://doi.org/10.1007/s11428-025-01338-6.
2. Eichenlaub M, Waldenmaier D, Pleus S, Haug C, Brandt D, Freckmann G. Compliance With FDA iCGM Special Controls is Dependent on Study Design and Procedures. J Diabetes Sci Technol. 2025 May;19(3):850-852. doi: 10.1177/19322968251329879. Epub 2025 Apr 2.
3. Safary E, Lepeska M, Beran D, Ewen M, Zhaparova A, Rukare J, Boulle P, Aebischer Perone S, Makohliso S, Pleus S, Vetter B. Development of a target product profile for new glucose self-monitoring technologies for use in low- and middle-income countries. PLoS One. 2024 Aug 26;19(8):e0309062. doi: 10.1371/journal.pone.0309062.
4. Kaltheuner M, Freckmann G, Nauck M, Heinemann L. LabDIAB: Ergebnisse einer Befragung zu Laboruntersuchungen mit Antworten von 66 diabetologischen Praxen. Diabetes Stoffw Herz. 2024;33,02/2024:108-112.
5. Pleus S, Eichenlaub M, Waldenmaier D, Freckmann G. A Critical Discussion of Alert Evaluations in the Context of Continuous Glucose Monitoring System Performance. J Diabetes Sci Technol. 2024 Jul;18(4):847-856. doi: 10.1177/19322968241236504. Epub 2024 Mar 13.
6. Eichenlaub M, Pleus S, Freckmann G. A Proposal for the Clinical Characterization of Continuous Glucose Monitoring Trend Arrow Accuracy. J Diabetes Sci Technol. 2024 Jul;18(4):800-807.
7. Pleus S, Eichenlaub M, Waldenmaier D, Freckmann G. Even Head-to-Head Comparison Studies of Continuous Glucose Monitoring System Performance Can be Biased. J Diabetes Sci Technol. 2024 May;18(3): 743-744.
8. Nauck M, Freckmann G, Heinemann L. Are You Using the Recommended Test Tubes for Glucose Measurement? New Guidelines for Pre-analytical Handling in Germany. J Diabetes Sci Technol. 2024 May;18(3):754-755.
9. Freckmann G, Waldenmaier D, Heinemann L. Head-to-Head Evaluation of Continuous Glucose Monitoring and Automated Insulin Delivery Systems: Why are They not Used More Systematically? J Diabetes Sci Technol. 2024 May;18(3):535-540.
10. Kaiser P, Grote-Koska D, Freckmann G, Petersmann A, Nauck M, Heinemann L. Glukose-Messungen und Rili-BÄK: Anpassung der Akzeptanzgrenzen bei der internen und externen Qualitätskontrolle. Diabetologie und Stoffwechsel 2023: doi: 10.1055/a-2170-5873.
11. Heinemann L, Scheper N, Freckmann G, Pleus S, Nauck M, Landgraf R, Schwarz R. Kommentar zu den Konsequenzen aus der „Befragung zur Güte der Glukosemessung in niedergelassenen diabetologischen Praxen basierend auf einer Strukturbefragung“. Diabetol. Stoffw. 2023: doi 10.1055/a-2096-7526.
12. Schwarz T, Scheper N, Freckmann G, Pleus S, Nauck M, Landgraf R, Heinmann L. Güte der Glukosemessung in niedergelassenen diabetologischen Praxen basierend auf einer Strukturbefragung. Diabetol. Stoffw. 2023: doi 10.1055/a-2096-2747.
13. Hermanns N, Ehrmann D, Finke-Groene K, Krichbaum M, Roos T, Haak T, Freckmann G, Kulzer B. Use of smartphone application versus written titration charts for basal insulin titration in adults with type 2 diabetes and suboptimal glycaemic control (My Dose Coach): multicentre, open-label, parallel, randomized controlled trial. The Lancet Regional Health -Europe 2023; 100702. doi.org/10.1016.
14. Freckmann G, Eichenlaub M, Waldenmaier D, Pleus S. Comment on Hochfellner et al. Accuracy Assessment of the GlucoMen Day CGM System in Individuals with Type 1 Diabetes: A Pilot Study. Biosensors 2022, 12, 106. Biosensors 2013, 13, 709.
15. Eichenlaub M, Stephan P, Waldenmaier D, Pleus S, Rothenbühler M, Haug C, Hinzmann R, Thomas A, Jendle J, Diem P, Freckmann G. Continuous Glucose Deviation Interval and Variability Analysis (CG-DIVA): A Novel Approach for the Statistical Accuracy Assessment of Continuous Glucose Monitoring Systems. J Diabetes Sci Technol. 2022 Nov 3:19322968221134639.
16. Pleus S, Eichenlaub M, Gerber T, Eriksson Boija E, Makris K, Haug C, Freckmann G. Improving the Bias of Comparator Methods in Analytical Performance Assessments Through Recalibration. J Diabetes Sci Technol. 2022 Oct 22:19322968221133107.
17. Freckmann G, Heinemann L, Pleus S, Petersmann A, Kaiser P, Nauck M. Messqualität bei der Glukosemessung im Rahmen der Diabetesdiagnose und- therapie in Deutschland. Dtsch Med Wochenschr. 2022 Jun 20;147:407-413
18. Freckmann G, Baumstark A, Hinzmann R, Haug C, Pleus S. Comment on "Do We Need the Replacement of YSI 2300? A View from the Clinical Laboratory" by Spanou and Makris. J Diabetes Sci Technol. 2022 May;16(3):790-791.
19. Klonoff DC, Wang J, Rodbard D, Kohn MA, Li C, Liepmann D, Kerr D, Ahn D, Peters AL, Umpierrez GE, Seley JJ, Xu NY, Nguyen KT, Simonson G, Agus MSD, Al-Sofiani ME, Armaiz-Pena G, Bailey TS, Basu A, Battelino T, Bekele SY, Benhamou PY, Bequette BW, Blevins A, Breton MD, Castle JR, Chase JG, Chen KY, Choudhary P, Clements MA, Close KL, Cook CB, Danne T, Doyle FJ 3rd, Drincic A, Dungan KM, Edelman SV, Ejskjaer N, Espinoza JC, Fleming GA, Forlenza GP, Freckmann G, Galindo RJ, Gomez AM, Gutow HA, Heinemann L, Hirsch IB, Hoang TD, Hovorka R, Jendle JH, Ji L, Joshi SR, Joubert M, Koliwad SK, Lal RA, Lansang MC, Lee WA, Leelarathna L, Leiter LA, Lind M, Litchman ML, Mader JK, Mahoney KM, Mankovsky B, Masharani U, Mathioudakis NN, Mayorov A, Messler J, Miller JD, Mohan V, Nichols JH, Nørgaard K, O'Neal DN, Pasquel FJ, Philis-Tsimikas A, Pieber T, Phillip M, Polonsky WH, Pop-Busui R, Rayman G, Rhee EJ, Russell SJ, Shah VN, Sherr JL, Sode K, Spanakis EK, Wake DJ, Waki K, Wallia A, Weinberg ME, Wolpert H, Wright EE, Zilbermint M, Kovatchev B. Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings. J Diabetes Sci Technol. 2023 Sep;17(5):1226-1242.
20. Eichenlaub M, Pleus S, Shaginian R, Richardson J, Pardo S, Stuhr A, Freckmann G. Impact of Blood Glucose Monitoring System Accuracy on Clinical Decision Making for Diabetes Management. J Diabetes Sci Technol. 2023 May;17(3):683-689.
21. Freckmann G, Nichols JH, Hinzmann R, Klonoff DC, Ju Y, Diem P, Makris K, Slingerland RJ. Standardization process of continuous glucose monitoring: Traceability and performance. Clin Chim Acta. 2021 Apr;515:5-12.
22. Ziegler R, Heinemann L, Freckmann G, Schnell O, Hinzmann R, Kulzer B. Intermittent Use of Continuous Glucose Monitoring: Expanding the Clinical Value of CGM. J Diabetes Sci Technol. 2021 May;15(3):684-694.
23. Kress S, Anderten H, Borck A, Freckmann G, Heinemann L, Holzmüller U, Kulzer B, Portele A, Schnell O, Varlemann H, Zemmrich C, Lobmann R. Preulcerous Risk Situation in Diabetic Foot Syndrome: Proposal for a Simple Ulcer Prevention Score. J Diabetes Sci Technol. 2021 Jul;15(4):816-826.
24. Auzanneau M, Rosenbauer J, Maier W, von Sengbusch S, Hamann J, Kapellen T, Freckmann G, Schmidt S, Lilienthal E, Holl RW. Heterogeneity of Access to Diabetes Technology Depending on Area Deprivation and Demographics Between 2016 and 2019 in Germany. J Diabetes Sci Technol. 2021 Sep;15(5):1059-1068.
25. Freckmann G, Buck S, Waldenmaier D, Zschornack E, Link M, Jendrike N, Obstfelder I, Vetrugno S, Kamann S, Haug C. Skin Reaction Report Form: Development and Design of a Standardized Report Form for Skin Reactions Due to Medical Devices for Diabetes Management. J Diabetes Sci Technol. 2021 Jul;15(4):801-806.
26. Eichenlaub M, Saccomani MP, Hattersley JG, Khovanova NA. Comment on “Minimal and Maximal Models to Quantitate Glucose Metabolism: Tools to Measure, to Simulate and to Run in Silico Clinical Trials”. J Diabetes Sci Technol. 2021.
27. Thomas A, Freckmann G. Wie valide ist für Patienten mit Typ-2-Diabetes der Einsatz von Diabetestechnologie? Diabetes Stoffw Herz 2021;30:244–251.
28. Pleus S, Kaiser P, Haug C. Glukosemessmethoden und ihr Einsatz, Qualitätssicherung und rechtliche Rahmenbedingungen bei Laboranalyse-, POCT- und CGM-Systemen. Diabetes aktuell 2021; 19: 8-13.
29. Freckmann G, Buck S, Waldenmaier D, Haug C. Methoden der Stoffwechselkontrolle – HbA1c versus „time in range“. Diabetologe 2021 17:223–234
30. Petersen B, Vesper I, Pachwald B, Dagenbach N, Buck S, Waldenmaier D, Heinemann L. Diabetes management intervention studies: lessons learned from two studies. Trials. 2021 Jan 18;22(1):61.
31. Tytko A, Schlüter S, Freckman G. Diabetesdiagnostik in der Praxis. Diabetes aktuell 2020; 18: 316–322.
32. Thomas A, Kolassa R. Messwertunterschiede und Messgenauigkeit von Systemen zum kontinuierlichen Glukosemonitoring. Diabetes aktuell 2020; 18: 336–341.
33. Baumstark A, Jendrike N. Blutzuckerselbstmessung – wie kann ein korrekter Wert erzielt werden? Diabetes aktuell 2020; 18: 323–327.
34. Blödt S, Brüggemann M, Freckmann G, Haase D, Heinemann L, Hoffmüller P, Hunfeld K, Klar E, Meisel C, Müller C, Nothacker M, Rabenaus H, Sachs U, Spitzenberger, F Stenzinger A, Vogeser M, Weichert W, Weinstock C, Zimmermann S. Europäische Verordnung über In-vitro-Diagnostika (IVDR) – Hinweis der Sektion „In-vitro-Diagnostik (IVD)“ der Ad-hoc-Kommission „Bewertung von Medizinprodukten“ der AWMF an alle Ärzte, die Labordiagnostik betreiben. GMS Zeitschrift zur Förderung der Qualitätssicherung in medizinischen Laboratorien. 2020;11.
35. Freckmann G, Buck S, Waldenmaier D, Zschornack E, Link M, Jendrike N, Obstfelder I, Vetrugno S, Kamann S, Haug C. Befundbogen zum Erfassen von Hautreaktionen im Diabetesmanagement. Diab Stoffw Herz 2020;29(4):217-222.
36. Buck S, Waldenmaier D, Haug C, Freckmann G, Rendschmidt T, Künsting T. Entwicklung einer neuen Patch-Pumpe für die Insulintherapie. Diab Stoffw Herz 2020;29(3):159-163.
37. Galindo RJ, Umpierrez GE, Rushakoff RJ, Basu A, Lohnes S, Nichols JH, Spanakis EK, Espinoza J, Palermo NE, Awadjie DG, Bak L, Buckingham B, Cook CB, Freckmann G, Heinemann L, Hovorka R, Mathioudakis N, Newman T, O'Neal DN, Rickert M, Sacks DB, Seley JJ, W Continuous Glucose Monitors and Automated Insulin Dosing Systems in the Hospital Consensus Guideline. J Diabetes Sci Technol. 2020 Nov;14(6):1035-1064.
38. Han J, Heinemann L, Ginsberg BH, Alva S, Appel M, Bess S, Chen KY, Freckmann G, Harris DR, Hartwig M, Hinzmann R, Kerr D, Krouwer J, Morrow L, Nichols J, Pfützner A, Pleus S, Rice M, Sacks DB, Schlueter K, Vesper HW, Klonoff DC. The YSI 2300 Analyzer Replacement Meeting Report. J Diabetes Sci Technol. 2020 May;14(3):679-686.
39. Heinemann L, Freckmann G, Müller-Wieland D, Kellerer M. Critical Reappraisal of the Time-in-Range: Alternative or Useful Addition to Glycated Hemoglobin? J Diabetes Sci Technol. 2020 Sep;14(5):922-927.
40. Ulbrich S, Waldenmaier D, Haug C, Freckmann G, Rendschmidt T, Künsting T. Concept and Implementation of a Novel Patch Pump for Insulin Delivery. J Diabetes Sci Technol. 2020 Mar;14(2):324-327.
41. Heinemann L, Schoemaker M, Schmelzeisen-Redecker G, Hinzmann R, Kassab A, Freckmann G, Reiterer F, Del Re L. Benefits and Limitations of MARD as a Performance Parameter for Continuous Glucose Monitoring in the Interstitial Space. J Diabetes Sci Technol. 2020 Jan;14(1):135-150.
42. Freckmann G, Pleus S, Baumstark A. Comment on "accuracy and precision of four main glucometers used in a sub-Saharan African country: a cross-sectional study" by Choukem et al. Pan Afr Med J. 2019 Jul 30;33:271.
43. Pleus S, Kamecke U, Waldenmaier D, Freckmann G. Reporting Insulin Pump Accuracy: Trumpet Curves According to IEC 60601-2-24 and Beyond. J Diabetes Sci Technol. 2019 May;13(3):592-596.
44. Heinemann L, Stuhr A, Brown A, Freckmann G, Breton MD, Russell S, Heinemann L. Self-measurement of Blood Glucose and Continuous Glucose Monitoring - Is There Only One Future? Eur Endocrinol. 2018 Sep;14(2):24-29.
45. Heinemann L, Kaiser P, Freckmann G, Grote-Koska D, Kerner W, Landgraf R, Merker L, Müller UA, Müller-Wieland D, Roth J, Spannagl M, Wallaschofski H, Nauck M. Higher HbA1c Measurement Quality Standards are Needed for Follow-Up and Diagnosis: Experience and Analyses from Germany. Horm Metab Res. 2018 Oct;50(10):e5.
46. Landgraf R, Nauck M, Freckmann G, Müller UA, Heinemann L, Kellerer M, Müller-Wieland D. Fallstricke bei der Diabetesdiagnostik: Wird zu lax mit Laborwerten umgegangen? Dtsch Med Wochenschr. 2018 Oct;143(21):1549-1555.
47. Schrangl P, Reiterer F, Heinemann L, Freckmann G, Del Re L. Limits to the Evaluation of the Accuracy of Continuous Glucose Monitoring Systems by Clinical Trials. Biosensors (Basel). 2018 May 18;8(2):50.
48. Pleus S, Heinemann L, Freckmann G. Blood Glucose Monitoring Data Should Be Reported in Detail When Studies About Efficacy of Continuous Glucose Monitoring Systems Are Published J Diabetes Sci Technol. 2018 Sep;12(5):1061-1063.

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