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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

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Sämann, A., Mühlhauser, I., Bender, R., Kloos, Ch., Müller, U. A.·2005·Diabetologia
DOI 10.1007/s00125-005-1905-1
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Abstract

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 have reported improved glycemic control comparable with DCCT while reducing the rates of severe hypoglycemia.

    “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]

    The Results (page not provided) report that mean HbA1c fell from 8.1% to 7.3% and severe hypoglycaemia fell from 0.37 to 0.14 events per patient-year after the programme. The paper does not establish that the improvement in glycaemic control was comparable to the DCCT; its Discussion cautions that comparisons with DCCT data are limited. (LLM, conf=0.88)

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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.

    “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]

  • The Insulin Treatment and Training programs developed by Mühlhauser and Berger have reported improved glycemic control comparable with DCCT while reducing the rates of severe hypoglycemia.

    “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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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
Publisher
Springer Science and Business Media LLC
Published
2005-08-18
Volume
48
Issue
10
Pages
1965-1970
ISSN
  • 0012-186X (ISSN-L)
  • 1432-0428
DOI
10.1007/s00125-005-1905-1
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
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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