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Glycaemic control and severe hypoglycaemia following training in flexible, intensive insulin therapy to enable dietary freedom in people with type 1 diabetes: a prospective implementation study
Open accessAbstract
Aims/hypothesis The aim of this study was to evaluate the implementation of a course teaching flexible, intensive insulin therapy on glycaemic control and severe hypoglycaemia in routine care.Methods This is a continuous quality-assurance project involving hospital diabetes centres. Every third year each centre re-examines 50 consecutive patients (evaluation sample) 1 year after participation in the course. Ninety-six diabetes centres in Germany participated and 9,583 patients with type 1 diabetes (190 evaluation samples) were re-examined between 1992 and 2004. The intervention was a 5-day inpatient course for groups of up to ten patients with a fixed curriculum of education and training for dietary flexibility and insulin adjustment. The main outcome measures were HbA1c and severe hypoglycaemia.Results Mean baseline HbA1c was 8.1%, and had decreased to 7.3% at follow-up; incidence of severe hypoglycaemia was 0.37 events per patient per year prior to intervention and 0.14 after intervention. In mixed-effects models adjusted for effects of centres, age and diabetes duration, the mean difference was -0.7% (95% CI -0.9 to -0.6%, p<0.0001) for HbA1c and -0.21 events per patient per year (95% CI -0.32 to -0.11, p=0.0001) for severe hypoglycaemia, with similar results for evaluation samples, with a maximum of 10% of patients lost to follow-up. Before intervention, the incidence of severe hypoglycaemia was three-fold higher in the lowest quartile than in the highest quartile of HbA1c, whereas the risk was comparable across the range of HbA1c values after intervention.Conclusions/interpretation Implemented as part of a continuous quality-assurance programme the self-management programme is effective and safe in routine care. Improvement of glycaemic control can be achieved without increasing the risk of severe hypoglycaemia.
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“The Insulin Treatment and Training programs developed by Mühlhauser and Berger (100) have reported improved glycemic control comparable with DCCT while reducing the rates of severe hypoglycemia (101,102).”
From Hypoglycemia and Diabetes: A Report of a Workgroup of the American Diabetes Association and The Endocrine Society (2013) · cites this paper as [102]
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“There is convincing evidence that formal training programs that teach patients to replace insulin “physiologically” by giving background and mealtime/correction doses of insulin can reduce the risk of severe hypoglycemia.”
From Hypoglycemia and Diabetes: A Report of a Workgroup of the American Diabetes Association and The Endocrine Society (2013) · cites this paper as [102]
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“The Insulin Treatment and Training programs developed by M € uhlhauser and Berger (100) have reported improved glycemic control comparable with DCCT while reducing the rates of severe hypoglycemia (101,102).”
From Hypoglycemia and Diabetes: A Report of a Workgroup of the American Diabetes Association and The Endocrine Society (2013) · cites this paper as [102]
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Self-citationEvaluation of a Structured Outpatient Group Education Program for Intensive Insulin Therapy
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Patient education—evaluation of a complex intervention
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Self-citationLiberalized diet in patients with type 1 diabetes
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Standards of medical care in diabetes—2014
American Diabetes Association (2014) · Diabetes Care · doi:10.2337/dc14-s014 · Cited by 4,572
Nutrition Therapy for Adults With Diabetes or Prediabetes: A Consensus Report
Evert, A. B., Dennison, M., Gardner, C. D., Garvey, W. T., Lau, K. H. K., MacLeod, J., Mitri, J., Pereira, R. F., Rawlings, K., Robinson, S., et al. (2019) · Diabetes Care · doi:10.2337/dci19-0014 · Cited by 1,496
Clinical Practice Guidelines for Multiple Endocrine Neoplasia Type 1 (MEN1)
Thakker, R. V., Newey, P. J., Walls, G. V., Bilezikian, J. P., Dralle, H., Ebeling, P. R., Melmed, S. K., Sakurai, A., Tonelli, F., & Brandi, M. L. (2012) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2012-1230 · Cited by 1,500
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“The Insulin Treatment and Training programs developed by M€ uhlhauser and Berger (100) have reported improved glycemic control comparable with DCCT while reducing the rates of severe hypoglycemia (101,102).”
BackgroundCryer, P. E., Axelrod, L., Grossman, A. B., Heller, S. R., Montori, V. M., Seaquist, E. R., & Service, F. J. (2009) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2008-1410 · Cited by 1,277
Metadata
- Authors
- Sämann, A., Mühlhauser, I., Bender, R., Kloos, C., & Müller, U. A.
- Affiliations
- Universität Hamburg (DE)
- Institute for Quality and Efficiency in Health Care (DE)
- Friedrich Schiller University Jena (DE)
- ORCID
- Müller, U. A.
- Venue
- Diabetologia
- Published
- 2005-08-18
- Volume
- 48
- Issue
- 10
- Pages
- 1965-1970
- ISSN
- 0012-186X (ISSN-L)
- 1432-0428
- OpenAlex
- W1991647428
- Cited by
- 226
- References
- 19
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 3 · 2023: 2 · 2022: 12 · 2021: 6 · 2020: 8 · 2019: 10 · 2018: 6 · 2017: 12 · 2016: 13 · 2015: 19 · 2014: 20 · 2013: 20 · 2012: 21
- FWCI
- 7.87
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Diabetologia (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Eli Lilly and Company
- Sanofi
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- type 1 diabetes, intensive insulin therapy, glycemic control, HbA1c, severe hypoglycemia, diabetes self-management education, quality assurance, insulin dose adjustment
- MeSH terms
- Adult, Blood Glucose, Diabetes Mellitus, Type 1, Diet, Female, Germany, Glycated Hemoglobin, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Male, Patient Education as Topic, Prospective Studies, Treatment Outcome, Total Quality Management
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