Management of adolescents with very poorly controlled type 1 diabetes by nurses: a parallel group randomized controlled trial.
BACKGROUND
Fluctuation in glycemia due to hormonal changes, growth periods, physical activity, and emotions make diabetes management difficult during adolescence. Our objective was to show that a close control of patients' self-management of diabetes by nurse-counseling could probably improve metabolic control in adolescents with type 1 diabetes.


METHODS
We designed a multicenter, randomized controlled, parallel group, clinical trial. Seventy seven adolescents aged 12-17 years with A1C >8% were assigned to either an intervention group (pediatrician visit every 3 months + nurse visit and phone calls) or to the control group (pediatrician visit every 3 months). The primary outcome was the evolution of the rate of A1C during the 12 months of follow-up. Secondary outcomes include patient's acceptance of the disease (evaluated by visual analog scale), the number of hypoglycemic or ketoacidosis episodes requiring hospitalization, and evaluation of A1C rate over time in each group.


RESULTS
Seventy-seven patients were enrolled by 10 clinical centers. Seventy (89.6%) completed the study, the evolution of A1C and participants satisfaction over the follow-up period was not significantly influenced by the nurse intervention.


CONCLUSIONS
Nurse-led intervention to improve A1C did not show a significant benefit in adolescents with type 1 diabetes because of lack of power. Only psychological management and continuous glucose monitoring have shown, so far, a slight but significant benefit on A1C. We did not show improvements in A1C control in teenagers by nurse-led intervention.


BACKGROUND
Clinical Trials.gov registration number: NCT00308256, 28 March 2006.
EPICIME-CIC 1407 de Lyon, Hospices Civils de Lyon, Inserm, Service de Pharmacologie Clinique, F-69677, Bron, France. behrouz.kassai@chu-lyon.fr.|Université de Lyon, F-69000, Lyon, France. behrouz.kassai@chu-lyon.fr.|CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Université Lyon 1, F-69622, Villeurbanne, France. behrouz.kassai@chu-lyon.fr.
Behrouz
B
Kassai
Hospices Civils de Lyon, Service de Biostatistiques, F-69324, Lyon, France. muriel.rabilloud@chu-lyon.fr.
Muriel
M
Rabilloud
EPICIME-CIC 1407 de Lyon, Hospices Civils de Lyon, Inserm, Service de Pharmacologie Clinique, F-69677, Bron, France. delphine.bernoux@chu-lyon.fr.|Endocrinologie, Diabétologie, Nutrition Pédiatriques, Hôpital Femme-Mère-Enfant, Hospices Civils de Lyon, F-69677, Bron, France. delphine.bernoux@chu-lyon.fr.
Delphine
D
Bernoux
Endocrinologie, Diabétologie, Nutrition Pédiatriques, Hôpital Femme-Mère-Enfant, Hospices Civils de Lyon, F-69677, Bron, France. catherine.michal@chu-lyon.fr.
Catherine
C
Michal
Hospices Civils de Lyon, Service de Biostatistiques, F-69324, Lyon, France. benjamin.riche@chu-lyon.fr.
Benjamin
B
Riche
EPICIME-CIC 1407 de Lyon, Hospices Civils de Lyon, Inserm, Service de Pharmacologie Clinique, F-69677, Bron, France. tiphanie.ginhoux@chu-lyon.fr.
Tiphanie
T
Ginhoux
EPICIME-CIC 1407 de Lyon, Hospices Civils de Lyon, Inserm, Service de Pharmacologie Clinique, F-69677, Bron, France. valerie.laudy@chu-lyon.fr.
Valérie
V
Laudy
Service de Pédiatrie Générale Multidisciplinaire, Hôpital Estaing-CHU de Clermont Ferrand, F-63003, Clermont-Ferrand, France. dterral@chu-clermontferrand.fr.
Daniel
D
Terral
Centre Hospitalier de la Région Annecienne (CHRA)-Service des Grands Enfants, F-74374, Pringy, France. cdidierwright@ch-annecy.fr.
Catherine
C
Didier-Wright
Centre Hospitalier de la Région Annecienne (CHRA)-Service des Grands Enfants, F-74374, Pringy, France. vmaire@ch-annecy.fr.
Veronique
V
Maire
Service de Pédiatrie, Hôpital de Vienne, F-38200, Vienne, France. c.dumont@ch-vienne.fr.
Catherine
C
Dumont
Centre Hospitalier de Sallanches-Service de Pédiatrie, F-74700, Sallanches, France. g.cottancin@ch-sallanches-chamonix.fr.
Gilles
G
Cottancin
Centre Hospitalier d'Albertville-Service de Pédiatrie, F-73200, Albertville Moûtiers, France. m.plasse@cham-savoie.fr.
Muriel
M
Plasse
Service de Pédiatrie, Centre Hospitalier de Roanne, F-42300, Roanne, France. guy-patrick.jeannoel@ch-roanne.fr.
Guy-Patrick
GP
Jeannoel
Service de Pédiatrie, Centre Hospitalier de Hyères, F-83407, Hyères, France. jkhoury@ch-hyeres.fr.
Jamil
J
Khoury
Cabinet de Pédiatrie, F-07100, Annonay, France. dr.bony-zyka@orange.fr.
Claire
C
Bony
EPICIME-CIC 1407 de Lyon, Hospices Civils de Lyon, Inserm, Service de Pharmacologie Clinique, F-69677, Bron, France. ml@upcl.uiv-lyon1.fr.|Université de Lyon, F-69000, Lyon, France. ml@upcl.uiv-lyon1.fr.|CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Université Lyon 1, F-69622, Villeurbanne, France. ml@upcl.uiv-lyon1.fr.
Michel
M
Lièvre
Fédération de Biochimie, Unité de Biochimie Métabolique et Moléculaire, Centre Hospitalier Lyon-Sud, F-69495, Pierre-Bénite, France. jocelyne.drai@chu-lyon.fr.
Jocelyne
J
Drai
Endocrinologie, Diabétologie, Nutrition Pédiatriques, Hôpital Femme-Mère-Enfant, Hospices Civils de Lyon, F-69677, Bron, France. marc.nicolino@chu-lyon.fr.
Marc
M
Nicolino
D000223:Adaptation, Psychological; D000293:Adolescent; D000294:Adolescent Behavior; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D002648:Child; D003376:Counseling; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000175:diagnosis / Q000451:nursing* / Q000523:psychology; D005260:Female; D005602:France; D006442:Glycated Hemoglobin / Q000378:metabolism; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D017060:Patient Satisfaction; D012648:Self Care; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
D015415:Biomarkers; D001786:Blood Glucose; D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human