Pharmaceutical care of adolescents with diabetes mellitus type 1: the DIADEMA study, a randomized controlled trial
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;...
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| Veröffentlicht in: | International journal of clinical pharmacy 2015-10, Vol.37 (5), p.790-798 |
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| container_title | International journal of clinical pharmacy |
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| creator | Obarcanin, Emina Krüger, Manfred Müller, Petra Nemitz, Verena Schwender, Holger Hasanbegovic, Snijezana Kalajdzisalihovic, Sena Läer, Stephanie |
| description | 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. |
| doi_str_mv | 10.1007/s11096-015-0122-3 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1719976042</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3829132761</sourcerecordid><originalsourceid>FETCH-LOGICAL-c442t-91d945aaaf6d0e3c9cd318d2e6020bcd1120a0da1e214921081e5758e5ca41dd3</originalsourceid><addsrcrecordid>eNp1kU1rGzEQhkVJSUyaH5BLEfSSQzfVaLW73txMPg0O6aE9i7E0rjdoV66kJbi_PkrthhCoQGhAz7zS8DB2CuIchGi-RQDR1oWAKm8pi_IDm0gJomgagIPXWpRH7CTGR5GXqiVU6pAdyaqFpmzqCQvf1xh6NDSmzqDjBgNxv-JovaNoaEiRP3VpzW2HS0oUeU_OdWmMPG03xOGCpzXxq_ns6vp-xmMa7fYrRx5wsL7v_pDlxg8peOdymUKH7hP7uEIX6WR_HrOfN9c_Lu-KxcPt_HK2KIxSMhUt2FZViLiqraDStMaWMLWSaiHF0lgAKVBYBJKg2jzsFKhqqilVBhVYWx6zs13uJvjfI8Wk-y5P5BwO5MeooYG2bWqhZEa_vEMf_RiG_Lu_lKrLWqlMwY4ywccYaKU3oesxbDUI_eJE75zo7ES_ONFl7vm8Tx6XPdnXjn8GMiB3QMxXwy8Kb57-b-oz67iVuQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1719463644</pqid></control><display><type>article</type><title>Pharmaceutical care of adolescents with diabetes mellitus type 1: the DIADEMA study, a randomized controlled trial</title><source>MEDLINE</source><source>SpringerNature Journals</source><creator>Obarcanin, Emina ; Krüger, Manfred ; Müller, Petra ; Nemitz, Verena ; Schwender, Holger ; Hasanbegovic, Snijezana ; Kalajdzisalihovic, Sena ; Läer, Stephanie</creator><creatorcontrib>Obarcanin, Emina ; Krüger, Manfred ; Müller, Petra ; Nemitz, Verena ; Schwender, Holger ; Hasanbegovic, Snijezana ; Kalajdzisalihovic, Sena ; Läer, Stephanie</creatorcontrib><description>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.</description><identifier>ISSN: 2210-7703</identifier><identifier>EISSN: 2210-7711</identifier><identifier>DOI: 10.1007/s11096-015-0122-3</identifier><identifier>PMID: 25917376</identifier><language>eng</language><publisher>Dordrecht: Springer Netherlands</publisher><subject>Adolescent ; Child ; Clinical outcomes ; Clinical trials ; Diabetes ; Diabetes Mellitus, Type 1 - drug therapy ; Diabetes Mellitus, Type 1 - metabolism ; Female ; Glycated Hemoglobin A - metabolism ; Humans ; Hypoglycemia - prevention & control ; Hypoglycemic Agents - therapeutic use ; Internal Medicine ; Male ; Medicine ; Medicine & Public Health ; Patient Care Team - organization & administration ; Pharmaceutical Services - organization & administration ; Pharmacology ; Pharmacy ; Research Article ; Teenagers</subject><ispartof>International journal of clinical pharmacy, 2015-10, Vol.37 (5), p.790-798</ispartof><rights>Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2015</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c442t-91d945aaaf6d0e3c9cd318d2e6020bcd1120a0da1e214921081e5758e5ca41dd3</citedby><cites>FETCH-LOGICAL-c442t-91d945aaaf6d0e3c9cd318d2e6020bcd1120a0da1e214921081e5758e5ca41dd3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s11096-015-0122-3$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s11096-015-0122-3$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25917376$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Obarcanin, Emina</creatorcontrib><creatorcontrib>Krüger, Manfred</creatorcontrib><creatorcontrib>Müller, Petra</creatorcontrib><creatorcontrib>Nemitz, Verena</creatorcontrib><creatorcontrib>Schwender, Holger</creatorcontrib><creatorcontrib>Hasanbegovic, Snijezana</creatorcontrib><creatorcontrib>Kalajdzisalihovic, Sena</creatorcontrib><creatorcontrib>Läer, Stephanie</creatorcontrib><title>Pharmaceutical care of adolescents with diabetes mellitus type 1: the DIADEMA study, a randomized controlled trial</title><title>International journal of clinical pharmacy</title><addtitle>Int J Clin Pharm</addtitle><addtitle>Int J Clin Pharm</addtitle><description>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.</description><subject>Adolescent</subject><subject>Child</subject><subject>Clinical outcomes</subject><subject>Clinical trials</subject><subject>Diabetes</subject><subject>Diabetes Mellitus, Type 1 - drug therapy</subject><subject>Diabetes Mellitus, Type 1 - metabolism</subject><subject>Female</subject><subject>Glycated Hemoglobin A - metabolism</subject><subject>Humans</subject><subject>Hypoglycemia - prevention & control</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Internal Medicine</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Patient Care Team - organization & administration</subject><subject>Pharmaceutical Services - organization & administration</subject><subject>Pharmacology</subject><subject>Pharmacy</subject><subject>Research Article</subject><subject>Teenagers</subject><issn>2210-7703</issn><issn>2210-7711</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1kU1rGzEQhkVJSUyaH5BLEfSSQzfVaLW73txMPg0O6aE9i7E0rjdoV66kJbi_PkrthhCoQGhAz7zS8DB2CuIchGi-RQDR1oWAKm8pi_IDm0gJomgagIPXWpRH7CTGR5GXqiVU6pAdyaqFpmzqCQvf1xh6NDSmzqDjBgNxv-JovaNoaEiRP3VpzW2HS0oUeU_OdWmMPG03xOGCpzXxq_ns6vp-xmMa7fYrRx5wsL7v_pDlxg8peOdymUKH7hP7uEIX6WR_HrOfN9c_Lu-KxcPt_HK2KIxSMhUt2FZViLiqraDStMaWMLWSaiHF0lgAKVBYBJKg2jzsFKhqqilVBhVYWx6zs13uJvjfI8Wk-y5P5BwO5MeooYG2bWqhZEa_vEMf_RiG_Lu_lKrLWqlMwY4ywccYaKU3oesxbDUI_eJE75zo7ES_ONFl7vm8Tx6XPdnXjn8GMiB3QMxXwy8Kb57-b-oz67iVuQ</recordid><startdate>20151001</startdate><enddate>20151001</enddate><creator>Obarcanin, Emina</creator><creator>Krüger, Manfred</creator><creator>Müller, Petra</creator><creator>Nemitz, Verena</creator><creator>Schwender, Holger</creator><creator>Hasanbegovic, Snijezana</creator><creator>Kalajdzisalihovic, Sena</creator><creator>Läer, Stephanie</creator><general>Springer Netherlands</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7T5</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20151001</creationdate><title>Pharmaceutical care of adolescents with diabetes mellitus type 1: the DIADEMA study, a randomized controlled trial</title><author>Obarcanin, Emina ; Krüger, Manfred ; Müller, Petra ; Nemitz, Verena ; Schwender, Holger ; Hasanbegovic, Snijezana ; Kalajdzisalihovic, Sena ; Läer, Stephanie</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c442t-91d945aaaf6d0e3c9cd318d2e6020bcd1120a0da1e214921081e5758e5ca41dd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adolescent</topic><topic>Child</topic><topic>Clinical outcomes</topic><topic>Clinical trials</topic><topic>Diabetes</topic><topic>Diabetes Mellitus, Type 1 - drug therapy</topic><topic>Diabetes Mellitus, Type 1 - metabolism</topic><topic>Female</topic><topic>Glycated Hemoglobin A - metabolism</topic><topic>Humans</topic><topic>Hypoglycemia - prevention & control</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Internal Medicine</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Patient Care Team - organization & administration</topic><topic>Pharmaceutical Services - organization & administration</topic><topic>Pharmacology</topic><topic>Pharmacy</topic><topic>Research Article</topic><topic>Teenagers</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Obarcanin, Emina</creatorcontrib><creatorcontrib>Krüger, Manfred</creatorcontrib><creatorcontrib>Müller, Petra</creatorcontrib><creatorcontrib>Nemitz, Verena</creatorcontrib><creatorcontrib>Schwender, Holger</creatorcontrib><creatorcontrib>Hasanbegovic, Snijezana</creatorcontrib><creatorcontrib>Kalajdzisalihovic, Sena</creatorcontrib><creatorcontrib>Läer, Stephanie</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>International journal of clinical pharmacy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Obarcanin, Emina</au><au>Krüger, Manfred</au><au>Müller, Petra</au><au>Nemitz, Verena</au><au>Schwender, Holger</au><au>Hasanbegovic, Snijezana</au><au>Kalajdzisalihovic, Sena</au><au>Läer, Stephanie</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pharmaceutical care of adolescents with diabetes mellitus type 1: the DIADEMA study, a randomized controlled trial</atitle><jtitle>International journal of clinical pharmacy</jtitle><stitle>Int J Clin Pharm</stitle><addtitle>Int J Clin Pharm</addtitle><date>2015-10-01</date><risdate>2015</risdate><volume>37</volume><issue>5</issue><spage>790</spage><epage>798</epage><pages>790-798</pages><issn>2210-7703</issn><eissn>2210-7711</eissn><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.</abstract><cop>Dordrecht</cop><pub>Springer Netherlands</pub><pmid>25917376</pmid><doi>10.1007/s11096-015-0122-3</doi><tpages>9</tpages></addata></record> |
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| ispartof | International journal of clinical pharmacy, 2015-10, Vol.37 (5), p.790-798 |
| issn | 2210-7703 2210-7711 |
| language | eng |
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| source | MEDLINE; SpringerNature Journals |
| subjects | Adolescent Child Clinical outcomes Clinical trials Diabetes Diabetes Mellitus, Type 1 - drug therapy Diabetes Mellitus, Type 1 - metabolism Female Glycated Hemoglobin A - metabolism Humans Hypoglycemia - prevention & control Hypoglycemic Agents - therapeutic use Internal Medicine Male Medicine Medicine & Public Health Patient Care Team - organization & administration Pharmaceutical Services - organization & administration Pharmacology Pharmacy Research Article Teenagers |
| title | Pharmaceutical care of adolescents with diabetes mellitus type 1: the DIADEMA study, a randomized controlled trial |
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