Should people with type 2 diabetes treated by multiple daily insulin injections with home health care support be switched to hybrid closed‐loop? The CLOSE AP+ randomized controlled trial
Aim The study aim was to evaluate the feasibility, safety and efficacy of automated insulin delivery (AID) assisted by home health care (HHC) services in people with type 2 diabetes unable to manage multiple daily insulin injections (MDI) at home on their own. Patients and Methods This was an open l...
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| Veröffentlicht in: | Diabetes, obesity & metabolism obesity & metabolism, 2024-02, Vol.26 (2), p.622-630 |
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| creator | Reznik, Yves Carvalho, Martin Fendri, Salha Prevost, Gaetan Chaillous, Lucy Riveline, Jean Pierre Hanaire, Hélène Dubois, Séverine Houéto, Patrick Pasche, Hélène Mianowska, Beata Renard, Eric |
| description | Aim
The study aim was to evaluate the feasibility, safety and efficacy of automated insulin delivery (AID) assisted by home health care (HHC) services in people with type 2 diabetes unable to manage multiple daily insulin injections (MDI) at home on their own.
Patients and Methods
This was an open label, multicentre, randomized, parallel group trial. In total, 30 adults with type 2 diabetes using MDI and requiring nursing support were randomly allocated to AID or kept their usual therapy over a 12‐week period. Both treatments were managed with the support of HHC services. The primary outcome was the percentage time in the target glucose range of 70‐180 mg/dl (TIR). Secondary outcomes included other continuous glucose monitoring metrics, glycated haemoglobin (HbA1c) levels, daily insulin doses, body weight, and of quality of life scores, fear of hypoglycaemia and satisfaction questionnaires.
Results
Age (69.7 vs. 69.3 years) and HbA1c (9.25 vs. 9.0) did not differ in MDI and AID at baseline. Compared with MDI, AID resulted in a significant increase in TIR by 27.4% [95% CI (15.0‐39.8); p |
| doi_str_mv | 10.1111/dom.15351 |
| format | Article |
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The study aim was to evaluate the feasibility, safety and efficacy of automated insulin delivery (AID) assisted by home health care (HHC) services in people with type 2 diabetes unable to manage multiple daily insulin injections (MDI) at home on their own.
Patients and Methods
This was an open label, multicentre, randomized, parallel group trial. In total, 30 adults with type 2 diabetes using MDI and requiring nursing support were randomly allocated to AID or kept their usual therapy over a 12‐week period. Both treatments were managed with the support of HHC services. The primary outcome was the percentage time in the target glucose range of 70‐180 mg/dl (TIR). Secondary outcomes included other continuous glucose monitoring metrics, glycated haemoglobin (HbA1c) levels, daily insulin doses, body weight, and of quality of life scores, fear of hypoglycaemia and satisfaction questionnaires.
Results
Age (69.7 vs. 69.3 years) and HbA1c (9.25 vs. 9.0) did not differ in MDI and AID at baseline. Compared with MDI, AID resulted in a significant increase in TIR by 27.4% [95% CI (15.0‐39.8); p < .001], a decrease in time above range by 27.7% and an unchanged time below range of <1%. A between‐group difference in HbA1c was 1.3% favouring AID. Neither severe hypoglycaemia nor ketoacidosis occurred in either group. Patient and caregiver satisfaction with AID was high.
Conclusions
AID combined with tailored HHC services significantly improved glycaemic control with no safety issues in people with type 2 diabetes previously under an MDI regimen with HHC. AID should be considered a safe option in these people when lacking acceptable glucose control.</description><identifier>ISSN: 1462-8902</identifier><identifier>EISSN: 1463-1326</identifier><identifier>DOI: 10.1111/dom.15351</identifier><identifier>PMID: 37921083</identifier><language>eng</language><publisher>Oxford, UK: DBlackwell Publishing Ltd</publisher><subject>automated insulin delivery ; Body weight ; Diabetes ; Diabetes mellitus (non-insulin dependent) ; Endocrinology and metabolism ; Glucose ; Glucose monitoring ; Health care ; Hemoglobin ; Home health care ; Human health and pathology ; hybrid closed loop ; Hypoglycemia ; Insulin ; Ketoacidosis ; Life Sciences ; Quality of life ; type 2 diabetes</subject><ispartof>Diabetes, obesity & metabolism, 2024-02, Vol.26 (2), p.622-630</ispartof><rights>2023 John Wiley & Sons Ltd.</rights><rights>2024 John Wiley & Sons Ltd.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3021-2041f0019b9a5b82c1da2ee570222662f2d248e9b7ee8bf5c20353acd22c13b63</citedby><cites>FETCH-LOGICAL-c3021-2041f0019b9a5b82c1da2ee570222662f2d248e9b7ee8bf5c20353acd22c13b63</cites><orcidid>0000-0002-6267-8058 ; 0000-0002-1862-0430 ; 0000-0002-3407-7263 ; 0000-0002-8794-8990</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fdom.15351$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fdom.15351$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,776,780,881,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37921083$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-04284019$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Reznik, Yves</creatorcontrib><creatorcontrib>Carvalho, Martin</creatorcontrib><creatorcontrib>Fendri, Salha</creatorcontrib><creatorcontrib>Prevost, Gaetan</creatorcontrib><creatorcontrib>Chaillous, Lucy</creatorcontrib><creatorcontrib>Riveline, Jean Pierre</creatorcontrib><creatorcontrib>Hanaire, Hélène</creatorcontrib><creatorcontrib>Dubois, Séverine</creatorcontrib><creatorcontrib>Houéto, Patrick</creatorcontrib><creatorcontrib>Pasche, Hélène</creatorcontrib><creatorcontrib>Mianowska, Beata</creatorcontrib><creatorcontrib>Renard, Eric</creatorcontrib><title>Should people with type 2 diabetes treated by multiple daily insulin injections with home health care support be switched to hybrid closed‐loop? The CLOSE AP+ randomized controlled trial</title><title>Diabetes, obesity & metabolism</title><addtitle>Diabetes Obes Metab</addtitle><description>Aim
The study aim was to evaluate the feasibility, safety and efficacy of automated insulin delivery (AID) assisted by home health care (HHC) services in people with type 2 diabetes unable to manage multiple daily insulin injections (MDI) at home on their own.
Patients and Methods
This was an open label, multicentre, randomized, parallel group trial. In total, 30 adults with type 2 diabetes using MDI and requiring nursing support were randomly allocated to AID or kept their usual therapy over a 12‐week period. Both treatments were managed with the support of HHC services. The primary outcome was the percentage time in the target glucose range of 70‐180 mg/dl (TIR). Secondary outcomes included other continuous glucose monitoring metrics, glycated haemoglobin (HbA1c) levels, daily insulin doses, body weight, and of quality of life scores, fear of hypoglycaemia and satisfaction questionnaires.
Results
Age (69.7 vs. 69.3 years) and HbA1c (9.25 vs. 9.0) did not differ in MDI and AID at baseline. Compared with MDI, AID resulted in a significant increase in TIR by 27.4% [95% CI (15.0‐39.8); p < .001], a decrease in time above range by 27.7% and an unchanged time below range of <1%. A between‐group difference in HbA1c was 1.3% favouring AID. Neither severe hypoglycaemia nor ketoacidosis occurred in either group. Patient and caregiver satisfaction with AID was high.
Conclusions
AID combined with tailored HHC services significantly improved glycaemic control with no safety issues in people with type 2 diabetes previously under an MDI regimen with HHC. AID should be considered a safe option in these people when lacking acceptable glucose control.</description><subject>automated insulin delivery</subject><subject>Body weight</subject><subject>Diabetes</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>Endocrinology and metabolism</subject><subject>Glucose</subject><subject>Glucose monitoring</subject><subject>Health care</subject><subject>Hemoglobin</subject><subject>Home health care</subject><subject>Human health and pathology</subject><subject>hybrid closed loop</subject><subject>Hypoglycemia</subject><subject>Insulin</subject><subject>Ketoacidosis</subject><subject>Life Sciences</subject><subject>Quality of life</subject><subject>type 2 diabetes</subject><issn>1462-8902</issn><issn>1463-1326</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNp1kcFu1DAQhiMEoqVw4AWQJS4gtK09TrLJqVothSItWqSWs-XYs4pXThxshyqceAQeiKfhSfA2pUhI-DK_rG_-8fjPsueMnrJ0zrTrTlnBC_YgO2Z5yReMQ_nwVsOiqikcZU9C2FNKc14tH2dHfFkDoxU_zn5etW60mgzoBovkxsSWxGlAAkQb2WDEQKJHGVGTZiLdaKM5gFoaOxHTh9GaPtU9qmhcH2aH1nVIWpQ2aSU9kjAOg_ORNEkmQrXJLjrSTo03mijrAupf339Y54Zzct0iWW-2Vxdk9ekN8bJP-5lvqUO5Pnpn7aHZG2mfZo920gZ8dldPss_vLq7Xl4vN9v2H9WqzUJwCWwDN2Y5SVje1LJoKFNMSEIslBYCyhB1oyCusmyVi1ewKBZQXXCoNCeVNyU-y17NvK60YvOmkn4STRlyuNuJwR3Oo8jTgK0vsq5kdvPsyYoiiM0GhtbJHNwYBVVWmdHIoEvryH3TvRt-nTQTUjFHOoYC_w5V3IXjc3b-AUXGIX6TvEbfxJ_bFnePYdKjvyT95J-BsBm6Mxen_TuLt9uNs-RtO9Ls1</recordid><startdate>202402</startdate><enddate>202402</enddate><creator>Reznik, Yves</creator><creator>Carvalho, Martin</creator><creator>Fendri, Salha</creator><creator>Prevost, Gaetan</creator><creator>Chaillous, Lucy</creator><creator>Riveline, Jean Pierre</creator><creator>Hanaire, Hélène</creator><creator>Dubois, Séverine</creator><creator>Houéto, Patrick</creator><creator>Pasche, Hélène</creator><creator>Mianowska, Beata</creator><creator>Renard, Eric</creator><general>DBlackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><general>Wiley</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><scope>1XC</scope><orcidid>https://orcid.org/0000-0002-6267-8058</orcidid><orcidid>https://orcid.org/0000-0002-1862-0430</orcidid><orcidid>https://orcid.org/0000-0002-3407-7263</orcidid><orcidid>https://orcid.org/0000-0002-8794-8990</orcidid></search><sort><creationdate>202402</creationdate><title>Should people with type 2 diabetes treated by multiple daily insulin injections with home health care support be switched to hybrid closed‐loop? The CLOSE AP+ randomized controlled trial</title><author>Reznik, Yves ; Carvalho, Martin ; Fendri, Salha ; Prevost, Gaetan ; Chaillous, Lucy ; Riveline, Jean Pierre ; Hanaire, Hélène ; Dubois, Séverine ; Houéto, Patrick ; Pasche, Hélène ; Mianowska, Beata ; Renard, Eric</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3021-2041f0019b9a5b82c1da2ee570222662f2d248e9b7ee8bf5c20353acd22c13b63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>automated insulin delivery</topic><topic>Body weight</topic><topic>Diabetes</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Endocrinology and metabolism</topic><topic>Glucose</topic><topic>Glucose monitoring</topic><topic>Health care</topic><topic>Hemoglobin</topic><topic>Home health care</topic><topic>Human health and pathology</topic><topic>hybrid closed loop</topic><topic>Hypoglycemia</topic><topic>Insulin</topic><topic>Ketoacidosis</topic><topic>Life Sciences</topic><topic>Quality of life</topic><topic>type 2 diabetes</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Reznik, Yves</creatorcontrib><creatorcontrib>Carvalho, Martin</creatorcontrib><creatorcontrib>Fendri, Salha</creatorcontrib><creatorcontrib>Prevost, Gaetan</creatorcontrib><creatorcontrib>Chaillous, Lucy</creatorcontrib><creatorcontrib>Riveline, Jean Pierre</creatorcontrib><creatorcontrib>Hanaire, Hélène</creatorcontrib><creatorcontrib>Dubois, Séverine</creatorcontrib><creatorcontrib>Houéto, Patrick</creatorcontrib><creatorcontrib>Pasche, Hélène</creatorcontrib><creatorcontrib>Mianowska, Beata</creatorcontrib><creatorcontrib>Renard, Eric</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><jtitle>Diabetes, obesity & metabolism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Reznik, Yves</au><au>Carvalho, Martin</au><au>Fendri, Salha</au><au>Prevost, Gaetan</au><au>Chaillous, Lucy</au><au>Riveline, Jean Pierre</au><au>Hanaire, Hélène</au><au>Dubois, Séverine</au><au>Houéto, Patrick</au><au>Pasche, Hélène</au><au>Mianowska, Beata</au><au>Renard, Eric</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Should people with type 2 diabetes treated by multiple daily insulin injections with home health care support be switched to hybrid closed‐loop? The CLOSE AP+ randomized controlled trial</atitle><jtitle>Diabetes, obesity & metabolism</jtitle><addtitle>Diabetes Obes Metab</addtitle><date>2024-02</date><risdate>2024</risdate><volume>26</volume><issue>2</issue><spage>622</spage><epage>630</epage><pages>622-630</pages><issn>1462-8902</issn><eissn>1463-1326</eissn><abstract>Aim
The study aim was to evaluate the feasibility, safety and efficacy of automated insulin delivery (AID) assisted by home health care (HHC) services in people with type 2 diabetes unable to manage multiple daily insulin injections (MDI) at home on their own.
Patients and Methods
This was an open label, multicentre, randomized, parallel group trial. In total, 30 adults with type 2 diabetes using MDI and requiring nursing support were randomly allocated to AID or kept their usual therapy over a 12‐week period. Both treatments were managed with the support of HHC services. The primary outcome was the percentage time in the target glucose range of 70‐180 mg/dl (TIR). Secondary outcomes included other continuous glucose monitoring metrics, glycated haemoglobin (HbA1c) levels, daily insulin doses, body weight, and of quality of life scores, fear of hypoglycaemia and satisfaction questionnaires.
Results
Age (69.7 vs. 69.3 years) and HbA1c (9.25 vs. 9.0) did not differ in MDI and AID at baseline. Compared with MDI, AID resulted in a significant increase in TIR by 27.4% [95% CI (15.0‐39.8); p < .001], a decrease in time above range by 27.7% and an unchanged time below range of <1%. A between‐group difference in HbA1c was 1.3% favouring AID. Neither severe hypoglycaemia nor ketoacidosis occurred in either group. Patient and caregiver satisfaction with AID was high.
Conclusions
AID combined with tailored HHC services significantly improved glycaemic control with no safety issues in people with type 2 diabetes previously under an MDI regimen with HHC. AID should be considered a safe option in these people when lacking acceptable glucose control.</abstract><cop>Oxford, UK</cop><pub>DBlackwell Publishing Ltd</pub><pmid>37921083</pmid><doi>10.1111/dom.15351</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-6267-8058</orcidid><orcidid>https://orcid.org/0000-0002-1862-0430</orcidid><orcidid>https://orcid.org/0000-0002-3407-7263</orcidid><orcidid>https://orcid.org/0000-0002-8794-8990</orcidid></addata></record> |
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| ispartof | Diabetes, obesity & metabolism, 2024-02, Vol.26 (2), p.622-630 |
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| source | Wiley Online Library Journals Frontfile Complete |
| subjects | automated insulin delivery Body weight Diabetes Diabetes mellitus (non-insulin dependent) Endocrinology and metabolism Glucose Glucose monitoring Health care Hemoglobin Home health care Human health and pathology hybrid closed loop Hypoglycemia Insulin Ketoacidosis Life Sciences Quality of life type 2 diabetes |
| title | Should people with type 2 diabetes treated by multiple daily insulin injections with home health care support be switched to hybrid closed‐loop? The CLOSE AP+ randomized controlled trial |
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