Click
here to close Hello! We notice that
you are using Internet Explorer, which is not supported by Echinobase
and may cause the site to display incorrectly. We suggest using a
current version of Chrome,
FireFox,
or Safari.
Int J Clin Pharm
2015 Oct 01;375:790-8. doi: 10.1007/s11096-015-0122-3.
Show Gene links
Show Anatomy links
Pharmaceutical care of adolescents with diabetes mellitus type 1: the DIADEMA study, a randomized controlled trial.
Obarcanin E
,
Krüger M
,
Müller P
,
Nemitz V
,
Schwender H
,
Hasanbegovic S
,
Kalajdzisalihovic S
,
Läer S
.
???displayArticle.abstract???
BACKGROUND: Physiological and psychological changes during puberty and a low adherence to complex treatment regimens often result in poor glycemic control in adolescents with type 1 diabetes mellitus (T1DM). The benefit of pharmaceutical care in adults with diabetes mellitus type 2 has been explored; however, evidence in adolescents with T1DM is scarce.
OBJECTIVE: To evaluate the impact of pharmaceutical care in adolescents with T1DM provided by pharmacists, in collaboration with physicians and diabetes educators on important clinical outcomes (e.g., HbA1c and severe hypoglycemia)
SETTING: At the outpatient Helios Paediatric Clinic and at the 12 regular community pharmacies of the study patients with 14 pharmacists in the Krefeld area, Germany, and at the University Pediatric Clinic with one clinical pharmacist on-site in Sarajevo, Bosnia-Herzegovina.
METHODS: A randomized, controlled, prospective, multicenter study in 68 adolescents with T1DM. The intervention group received monthly structured pharmaceutical care visits delivered by pharmacists plus supplementary visits and phone calls on an as needed basis, for 6 months. The control group received usual diabetic care. Data were collected at baseline and after 3 and 6 months.
MAIN OUTCOME MEASURES: The between-group difference in the change from baseline in glycosylated hemoglobin (HbA1c) and the number of severe hypoglycemic events in both groups.
RESULTS: The improvement from baseline in HbA1c was significantly greater in the intervention group than in the control group after 6 months (change from baseline -0.54 vs. +0.32%, p = 0.0075), even after adjustment for country-specific variables (p = 0.0078). However, the effect was more pronounced after only 3 months (-1.09 vs. +0.23%, p = 0.00002). There was no significant between-group difference in the number of severe hypoglycemia events. (p = 0.1276).
CONCLUSION: This study suggests that multidisciplinary PhC may add value in the management of T1DM in adolescents with inadequate glycemic control. However, the optimal methods on how to achieve sustained, long-term improvements in this challenging population require further study.
American Diabetes Association,
Economic costs of diabetes in the U.S. in 2012.
2013, Pubmed
American Diabetes Association,
Economic costs of diabetes in the U.S. in 2012.
2013,
Pubmed
American Diabetes Association,
Management of dyslipidemia in children and adolescents with diabetes.
2003,
Pubmed
Berger,
A review of methods for ensuring the comparability of comparison groups in randomized clinical trials.
2006,
Pubmed
Blume,
Randomization in controlled clinical trials: why the flip of a coin is so important.
2004,
Pubmed
Borus,
Adherence challenges in the management of type 1 diabetes in adolescents: prevention and intervention.
2010,
Pubmed
Chisholm-Burns,
US pharmacists' effect as team members on patient care: systematic review and meta-analyses.
2010,
Pubmed
Clark,
Holiday review. How random is the toss of a coin?
2009,
Pubmed
DIAMOND Project Group,
Incidence and trends of childhood Type 1 diabetes worldwide 1990-1999.
2006,
Pubmed
Daneman,
Type 1 diabetes.
2006,
Pubmed
Dumville,
The use of unequal randomisation ratios in clinical trials: a review.
2006,
Pubmed
Ehehalt,
Epidemiological perspectives on type 1 diabetes in childhood and adolescence in germany: 20 years of the Baden-württemberg Diabetes Incidence Registry (DIARY).
2010,
Pubmed
Faul,
G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences.
2007,
Pubmed
Frank,
Psychological issues in the care of children and adolescents with type 1 diabetes.
2005,
Pubmed
Gail,
How many controls?
1976,
Pubmed
Gay,
Reinforced follow-up for children and adolescents with type 1 diabetes and inadequate glycaemic control: a randomized controlled trial intervention via the local pharmacist and telecare.
2006,
Pubmed
Harjutsalo,
Time trends in mortality in patients with type 1 diabetes: nationwide population based cohort study.
2011,
Pubmed
Kaufman,
Association between diabetes control and visits to a multidisciplinary pediatric diabetes clinic.
1999,
Pubmed
Krass,
The Pharmacy Diabetes Care Program: assessment of a community pharmacy diabetes service model in Australia.
2007,
Pubmed
Machado,
Sensitivity of patient outcomes to pharmacist interventions. Part I: systematic review and meta-analysis in diabetes management.
2007,
Pubmed
Mehuys,
Effectiveness of a community pharmacist intervention in diabetes care: a randomized controlled trial.
2011,
Pubmed
Patino,
Health beliefs and regimen adherence in minority adolescents with type 1 diabetes.
2005,
Pubmed
Patterson,
Incidence trends for childhood type 1 diabetes in Europe during 1989-2003 and predicted new cases 2005-20: a multicentre prospective registration study.
2009,
Pubmed
Phan,
Quarterly visits with glycated hemoglobin monitoring: the sweet spot for glycemic control in youth with type 1 diabetes.
2014,
Pubmed
Schober,
Prevalence of intentional under- and overdosing of insulin in children and adolescents with type 1 diabetes.
2011,
Pubmed
Sims,
Challenges of a pharmacist-directed peer support program among adolescents with diabetes.
2011,
Pubmed
Svoren,
Reducing acute adverse outcomes in youths with type 1 diabetes: a randomized, controlled trial.
2003,
Pubmed
Tahirović,
Incidence of type 1 diabetes mellitus in children in Tuzla Canton between 1995 and 2004.
2007,
Pubmed
Viera,
Eliminating bias in randomized controlled trials: importance of allocation concealment and masking.
2007,
Pubmed
Wermeille,
Pharmaceutical care model for patients with type 2 diabetes: integration of the community pharmacist into the diabetes team--a pilot study.
2004,
Pubmed
Workgroup on Hypoglycemia, American Diabetes Association,
Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia.
2005,
Pubmed
Writing Team for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group,
Sustained effect of intensive treatment of type 1 diabetes mellitus on development and progression of diabetic nephropathy: the Epidemiology of Diabetes Interventions and Complications (EDIC) study.
2003,
Pubmed
de Wit,
Validation of the WHO-5 Well-Being Index in adolescents with type 1 diabetes.
2007,
Pubmed
van Mil,
Pharmaceutical care, European developments in concepts, implementation, teaching, and research: a review.
2004,
Pubmed