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Diabetes Care 26:3352-3353, 2003
© 2003 by the American Diabetes Association, Inc.

Letters: Observations

Prospective Audit of the Introduction of Insulin Glargine (Lantus) Into Clinical Practice in Type 1 Diabetic Patients

Ian W. Gallen, MD, FRCP and Celia Carter, RGN

From the South Buckinghamshire National Health Services Trust, Wycombe Hospital, Buckinghamshire, U.K.

Address correspondence to Dr. Ian Gallen, Diabetes Centre, Wycombe Hospital, High Wycombe, Buckinghamshire HP11 2TT, U.K. E-mail: ian.gallen{at}sbucks.nhs.uk

Insulin glargine is a modified basal insulin analog that has been recently introduced, and following guidance from the National Institute for Clinical Excellence (NICE), it is now widely available in the U.K. (1). Studies in type 1 diabetes demonstrate that compared with NPH insulin, fasting blood glucose and hypoglycemic episodes are reduced and patient satisfaction is improved (2–7). To confirm whether these reported benefits are also achieved in routine clinical practice, we conducted a prospective audit of patients attending our diabetes clinic practice transferring to insulin glargine.

There were 83 patients with type 1 diabetes on multiple daily injection regimes who were transferred from NPH insulin to insulin glargine between July and November 2002. Indications for transfer were nocturnal hypoglycemia, morning fasting hyperglycemia, the use of two NPH injections, or patient request. Patient details, including glycemic control (glucose concentrations and HbA1c levels), were recorded. Patients completed a questionnaire on the frequency of hypoglycemia (requiring corrective action by patient) over the preceding month and severe hypoglycemic episodes (requiring assistance from a third party) over the 3 months preceding the initiation of insulin glargine therapy. Patient assessments on quality of life and well-being (Diabetes Treatment Satisfaction Questionnaire and Well-Being Questionnaire 28) (8,9) were also performed. Patients were reassessed after receiving insulin glargine for 3 months.

Morning blood glucose concentrations and HbA1c levels fell significantly, from 9.63 ± 0.44 to 7.15 ± 0.28 mmol/l (P < 0.001) and from 8.24 ± 0.16 to 7.86 ± 0.11% (P = 0.006), respectively. Total hypoglycemic episodes remained unchanged after transferral to insulin glargine. The number of severe hypoglycemic episodes was not statistically significantly different after transfer to glargine from baseline values (from 15 to 7) (P = 0.077). Aggregate scores for the Diabetes Treatment Satisfaction Questionnaire, which reflect satisfaction with treatment, improved from 23.5 (0.68) to 28 (0.67) (P < 0.001), whereas the score for unacceptably high blood glucose values fell from 3.53 (0.16) to 2.83 (0.17) (P = 0.002) with no significant change for unacceptably low blood glucose values (from 2.43 [0.16] to 2.11 [0.14]) (P = 0.07). The scores for the Well-Being Questionnaire 28 show significant improvements in patient-reported energy levels (P < 0.001), diabetes-specific well-being (P = 0.044), and total well-being (P = 0.001), with significant reductions in diabetes-related stress (P = 0.014).

Our results confirm that people with type 1 diabetes on a multiple daily insulin injection regime who transfer to insulin glargine from isophane insulin have a significant fall in their morning blood glucose concentrations and HbA1c levels as well as significant improvements in satisfaction with their treatment and subjective well-being. The use of insulin glargine appears to be advantageous for some patients with type 1 diabetes.

References

  1. National Institute for Clinical Excellence: Technology Appraisal Guidance: Guidance on the Use of Long-Acting Insulin Analogues for Treatment of Diabetes: Insulin Glargine. London, National Institute for Clinical Excellence, 2002 (no. 53)
  2. Pieber TR, Eugene-Jolchine I, Derobert E: Efficacy and safety of HOE 901 versus NPH insulin in patients with type 1 diabetes: the European Study Group of HOE 901 in type 1 diabetes. Diabetes Care 23:157–162, 2000[Abstract]
  3. Raskin P, Klaff L, Bergenstal R, Halle JP, Donley D, Mecca T: A 16-week comparison of the novel insulin analog insulin glargine (HOE 901) and NPH human insulin used with insulin lispro in patients with type 1 diabetes. Diabetes Care 23:1666–1671, 2000[Abstract/Free Full Text]
  4. Rosenstock J, Park G, Zimmerman J, the US Insulin Glargine (HOE 901) Type 1 Diabetes Investigator Group: Basal insulin glargine (HOE 901) versus NPH insulin in patients with type 1 diabetes on multiple daily insulin regimens. Diabetes Care 23:1137–1142, 2000[Abstract/Free Full Text]
  5. Porcellati F, Rossetti P, Fanelli C, Scionti L, Brunetti P, Bolli GB: Glargine vs NPH as basal insulin in intensive treatment of type 1 diabetes mellitus given lispro at meals: one year comparison (Abstract). Diabetes 51: (Suppl. 2):A53, 2002
  6. Ratner RE, Hirsch IB, Neifing JL, Garg SK, Mecca TE, Wilson CA, the US Study Group of Insulin Glargine in Type 1 Diabetes: Less hypoglycemia with insulin glargine in intensive insulin therapy for type 1 diabetes. Diabetes Care 23:639–643, 2000[Abstract/Free Full Text]
  7. Witthaus E, Stewart J, Bradley C: Treatment satisfaction and psychological well-being with insulin glargine compared with NPH in patients with type 1 diabetes. Diabet Med 18:619–625, 2001[Medline]
  8. Bradley C, Todd C, Gorton T, Symonds E, Martin A, Plowright R: The development of an individualized questionnaire measure of perceived impact of diabetes on quality of life: the ADDQoL. Qual Life Res 8:79–91, 1999[Medline]
  9. Speight J, Bradley C: The W-BQ28 measure of generic and diabetes-specific well-being is shown to be valid, reliable and sensitive to change in DIABQoL+ and DAFNE studies. Diabet Med 19:10, 2002

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