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Randomized Controlled Trial
. 2008 Apr;54(4):550-8.

Can family physicians help patients initiate basal insulin therapy successfully?: randomized trial of patient-titrated insulin glargine compared with standard oral therapy: lessons for family practice from the Canadian INSIGHT trial

Stewart Harris  1 , Jean-François Yale, Ellen Dempsey, Hertzel Gerstein
Affiliations
Randomized Controlled Trial

Can family physicians help patients initiate basal insulin therapy successfully?: randomized trial of patient-titrated insulin glargine compared with standard oral therapy: lessons for family practice from the Canadian INSIGHT trial

Stewart Harris et al. Can Fam Physician. 2008 Apr.

Abstract
in English, French

Objective: To determine whether FPs could help patients implement bedtime basal insulin therapy as successfully as diabetes experts could.

Design: National, multicentre, randomized, open-label trial designed to assess use of bedtime basal insulin therapy compared with use of standard oral-agent therapy for patients with type 2 diabetes being treated by diabetes experts or FPs.

Setting: Nineteen endocrinologist or expert sites and 34 family practices.

Participants: A total of 405 adult patients with hemoglobin A1c (HbA1c) values of 7.5% to 11.0% who were taking 0 to 2 oral agents.

Intervention: Participants were randomized to receive either basal insulin therapy using glargine self-titrated according to a patient algorithm or conventional therapy with physician-adjusted doses of oral agents for a period of 24 weeks.

Main outcome measures: The primary outcome was time to achieve 2 consecutive HbA1c values < or = 6.5%. Secondary outcomes were the proportion of subjects who achieved these HbA1c values, a fasting plasma glucose level < or = 5.5 mmol/L, and 2 consecutive HbA1c values < or = 7.0%; incidence, rate, and severity of hypoglycemia; daily variations in blood-glucose levels; and participants' lipid profiles. Post-hoc analysis sought to determine whether patients' outcomes differed in terms of the above measures depending on whether they had been treated by diabetes experts or FPs.

Results: A total of 206 patients were randomized to the glargine group, and 199 to the oral agents group. In total, 145 patients were followed by experts and 260 by FPs. Mean reductions in HbA1c and fasting plasma glucose levels and rates of hypoglycemia were comparable in the 2 groups. Patients of both types of physicians achieved significantly greater reductions in fasting plasma glucose with glargine than with oral agents (FPs: -4.14 vs -2.45 mmol/L, P = .0001; experts: -3.47 vs -2.19 mmol/L, P = .0013). Patients of FPs achieved significantly greater reductions in HbA1c levels with glargine than with oral agents (FPs: -1.64 vs -1.26%, P = .0058; experts: -1.41 vs-1.24%, P = .3331). Final mean insulin doses were higheramong FPs' patients than among experts' patients (41.74vs 31.66 units, P = .015). Family physicians were more aggressive in their use of insulin, while experts used more oral agents. There were no significant differences inefficacy of treatment.

Conclusion: In most settings, FPs could easily implement the patient-driven bedtime basal insulin protocol used in this study.

OBJECTIF: Déterminer si le MF peut aider son patient à amorcer une insulinothérapie de base au coucher avec autant de succès qu’un expert en diabète.

TYPE D’ÉTUDE: Essai multicentrique national contrôlé sans insu comparant l’utilisation d’une insulinothérapie basale au coucher à l’usage d’hypoglycémiants oraux standards chez les diabétiques de type 2 traités par des experts du diabète ou par des MF.

CONTEXTE: Dix-neuf cliniques d’endocrinologues ou d’experts en diabète et 34 cliniques de médecine familiale.

PARTICIPANTS: Un total de 405 adultes avec des valeurs d’hémoglobine A1c(HbA 1c) entre 7,5% et 11,0% et prenant 0–2 hypoglycémiants oraux.

INTERVENTION: Les participants ont été choisis au hasard pour recevoir soit une insulinothérapie basale à l’aide de glargine auto-titrée suivant un algorithme propre au patient, soit un traitement conventionnel avec des doses d’hypoglycémiants ajustées par un médecin sur une période de 24 semaines.

PRINCIPAUX PARAMÈTRES MESURÉS: L’issue primaire était le temps requis pour atteindre 2 valeurs consécutives d’HbA1c ≤ 6,5%. Les issues secondaires étaient: nombre de sujets atteignant ce niveau d’ HbA1c, une glycémie à jeun ≤ 5,5 mmol/L et 2 valeurs consécutives d’HbA1c ≤ 7,0%; incidence, taux et sévérité des hypoglycémies; variations quotidiennes de la glycémie; et profil lipidique des participants. Une analyse subséquente cherchait à savoir si les issues des paramètres ci-haut mentionnés différaient selon que les patients avaient été traités par des experts du diabète ou par des MF.

RÉSULTATS: Un total de 206 patients ont été choisis pour le groupe glargine et 199 pour le groupe hypoglycémiants oraux. Au total, 145 patients ont été suivis par des experts et 260 par des MF. Les réductions moyennes d’HbA1c et de glycémie à jeun et les taux d’hypoglycémie étaient comparables dans les 2 groupes. Les patients suivis par les 2 types de médecins ont atteint une diminution de glycémie à jeun significativement plus grande avec la glargine qu’avec les hypoglycémiants oraux (MF: −4,14 vs −2,45 mmol/L, P = 0,0001; experts: −3,47 vs −2,19 mmol/L, P = 0,0013). Les patients des MF ont obtenu des diminutions d’HbA1c significativement plus grandes avec la glargine qu’avec ; les hypoglycémiants oraux (MF: −1,64 vs −1,26%, P = 0,0058; experts: −1,41 vs −1,24%, P = 0,3331). Les doses finales d’insuline étaient plus élevées en moyenne chez les patients des MF que chez ceux des experts (41,74 vs 31,66 unités, P = 0,015). Les MF étaient plus agressifs dans l’usage de l’insuline alors que les experts recouraient davantage aux hypoglycémiants oraux. Il n’y avait pas de différence significative dans l’efficacité du traitement.

CONCLUSION: Dans la plupart des contextes, le MF pourrait facilement instaurer le protocole basal d’insuline au coucher géré par le patient utilisé dans cette étude.

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Figures

Figure 1
Figure 1
Disposition of subjects
Figure 2
Figure 2
Glycemic control by treatment arm at study visits at baseline, week 8, week 12, and week 24 (mean and 95% confidence intervals): A) FPG levels. B) HbA1c levels.
Figure 3
Figure 3
Medication use by day and type of physician: A) Median dose of insulin glargine. B) Mean number of oral agents taken.
See this image and copyright information in PMC

References

    1. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33) Lancet. 1998;352:837–53. - PubMed
    1. Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. Canadian Diabetes Association 2003 clinical practice guidelines for the prevention and management of diabetes in Canada. Can J Diabetes. 2003;27(Suppl 2):S1–152. - PubMed
    1. American Diabetes Association. Standards of medical care for patients with diabetes mellitus. Diabetes Care. 2006;29(Suppl 1):S4–42. - PubMed
    1. International Diabetes Federation. Global guideline for type 2 diabetes. Brussels, Belg: International Diabetes Federation; 2005. [Accessed 2006 April 17]. Available from: www.idf.org.
    1. Jaakkimainen L, Biaju RS, Kopp A. Sources of physician care for people with diabetes. In: Hux JE, Booth G, Slaughter P, Laupacis A, editors. Diabetes in Ontario: an ICES practice atlas. Toronto, ON: Institute for Clinical Evaluative Sciences; 2003. pp. 9.181–92.

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