Continuous Glucose Monitoring-Recorded Hypoglycemia with Insulin Degludec or Insulin Glargine U100 in People with Type 1 Diabetes Prone to Nocturnal Severe Hypoglycemia
Background and Aims: Nocturnal hypoglycemia is mainly a consequence of inappropriate basal insulin therapy in type 1 diabetes (T1D) and may compromise optimal glycemic control. Insulin degludec is associated with a lower risk of nocturnal hypoglycemia in T1D. As nocturnal hypoglycemia is often asymp...
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| Veröffentlicht in: | Diabetes technology & therapeutics 2022-09, Vol.24 (9), p.643-654 |
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| creator | Brøsen, Julie Maria Bøggild Agesen, Rikke Mette Alibegovic, Amra Ciric Ullits Andersen, Henrik Beck-Nielsen, Henning Gustenhoff, Peter Krarup Hansen, Troels Hedetoft, Christoffer Georg Riber Jensen, Tonny Joran Stolberg, Charlotte Røn Bogh Juhl, Claus Lerche, Susanne Søgaard Nørgaard, Kirsten Parving, Hans-Henrik Tarnow, Lise Thorsteinsson, Birger Pedersen-Bjergaard, Ulrik |
| description | Background and Aims: Nocturnal hypoglycemia is mainly a consequence of inappropriate basal insulin therapy in type 1 diabetes (T1D) and may compromise optimal glycemic control. Insulin degludec is associated with a lower risk of nocturnal hypoglycemia in T1D. As nocturnal hypoglycemia is often asymptomatic, we applied continuous glucose monitoring (CGM) to detect a more precise occurrence of nocturnal hypoglycemia in the HypoDeg trial, comparing insulin degludec with insulin glargine U100 in people with T1D and previous nocturnal severe hypoglycemia. Materials and Methods: In the HypoDeg trial, 149 people with T1D were included in an open-label randomized cross-over trial. Sixty-seven participants accepted optional participation in the predefined substudy of 4 × 6 days of blinded CGM requiring completion of at least one CGM period in each treatment arm. CGM data were reviewed for hypoglycemic events. Results: Treatment with insulin degludec resulted in a relative rate reduction (RRR) of 36% (95% confidence interval [CI]: 10%–54%; P |
| doi_str_mv | 10.1089/dia.2021.0567 |
| format | Article |
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Insulin degludec is associated with a lower risk of nocturnal hypoglycemia in T1D. As nocturnal hypoglycemia is often asymptomatic, we applied continuous glucose monitoring (CGM) to detect a more precise occurrence of nocturnal hypoglycemia in the HypoDeg trial, comparing insulin degludec with insulin glargine U100 in people with T1D and previous nocturnal severe hypoglycemia. Materials and Methods: In the HypoDeg trial, 149 people with T1D were included in an open-label randomized cross-over trial. Sixty-seven participants accepted optional participation in the predefined substudy of 4 × 6 days of blinded CGM requiring completion of at least one CGM period in each treatment arm. CGM data were reviewed for hypoglycemic events. Results: Treatment with insulin degludec resulted in a relative rate reduction (RRR) of 36% (95% confidence interval [CI]: 10%–54%; P < 0.05) in nocturnal CGM-recorded hypoglycemia (≤3.9 mmol/L), corresponding to an absolute rate reduction (ARR) of 0.85 events per person-week. In nocturnal CGM-recorded hypoglycemia (≤3.0 mmol/L), we found an RRR of 53% (95% CI: 36%–65%; P < 0.001), corresponding to an ARR of 0.75 events per person-week. At the lower detection limit of the CGM (≤2.2 mmol/L), treatment with insulin degludec resulted in a significant RRR of 58% (95% CI: 23%–77%; P = 0.005). The reductions were primarily due to significant RRRs in asymptomatic hypoglycemia. Conclusion: In people with T1D, prone to nocturnal severe hypoglycemia, insulin degludec compared with insulin glargine U100 significantly reduces nocturnal CGM-recorded hypoglycemia. www.clinicaltrials.gov (#NCT02192450).</description><identifier>ISSN: 1520-9156</identifier><identifier>EISSN: 1557-8593</identifier><identifier>DOI: 10.1089/dia.2021.0567</identifier><language>eng</language><publisher>New Rochelle: Mary Ann Liebert, Inc</publisher><subject>Asymptomatic ; Diabetes ; Glucose monitoring ; Hypoglycemia ; Insulin</subject><ispartof>Diabetes technology & therapeutics, 2022-09, Vol.24 (9), p.643-654</ispartof><rights>Copyright Mary Ann Liebert, Inc. Sep 2022</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c337t-64cb0206b2a6cde6d614957d62fcacd8d3318f0cc69e93a4a28d318d8f6a2fb03</citedby><cites>FETCH-LOGICAL-c337t-64cb0206b2a6cde6d614957d62fcacd8d3318f0cc69e93a4a28d318d8f6a2fb03</cites><orcidid>0000-0001-7361-4407 ; 0000-0002-7649-7928</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27902,27903</link.rule.ids></links><search><creatorcontrib>Brøsen, Julie Maria Bøggild</creatorcontrib><creatorcontrib>Agesen, Rikke Mette</creatorcontrib><creatorcontrib>Alibegovic, Amra Ciric</creatorcontrib><creatorcontrib>Ullits Andersen, Henrik</creatorcontrib><creatorcontrib>Beck-Nielsen, Henning</creatorcontrib><creatorcontrib>Gustenhoff, Peter</creatorcontrib><creatorcontrib>Krarup Hansen, Troels</creatorcontrib><creatorcontrib>Hedetoft, Christoffer Georg Riber</creatorcontrib><creatorcontrib>Jensen, Tonny Joran</creatorcontrib><creatorcontrib>Stolberg, Charlotte Røn</creatorcontrib><creatorcontrib>Bogh Juhl, Claus</creatorcontrib><creatorcontrib>Lerche, Susanne Søgaard</creatorcontrib><creatorcontrib>Nørgaard, Kirsten</creatorcontrib><creatorcontrib>Parving, Hans-Henrik</creatorcontrib><creatorcontrib>Tarnow, Lise</creatorcontrib><creatorcontrib>Thorsteinsson, Birger</creatorcontrib><creatorcontrib>Pedersen-Bjergaard, Ulrik</creatorcontrib><title>Continuous Glucose Monitoring-Recorded Hypoglycemia with Insulin Degludec or Insulin Glargine U100 in People with Type 1 Diabetes Prone to Nocturnal Severe Hypoglycemia</title><title>Diabetes technology & therapeutics</title><description>Background and Aims: Nocturnal hypoglycemia is mainly a consequence of inappropriate basal insulin therapy in type 1 diabetes (T1D) and may compromise optimal glycemic control. Insulin degludec is associated with a lower risk of nocturnal hypoglycemia in T1D. As nocturnal hypoglycemia is often asymptomatic, we applied continuous glucose monitoring (CGM) to detect a more precise occurrence of nocturnal hypoglycemia in the HypoDeg trial, comparing insulin degludec with insulin glargine U100 in people with T1D and previous nocturnal severe hypoglycemia. Materials and Methods: In the HypoDeg trial, 149 people with T1D were included in an open-label randomized cross-over trial. Sixty-seven participants accepted optional participation in the predefined substudy of 4 × 6 days of blinded CGM requiring completion of at least one CGM period in each treatment arm. CGM data were reviewed for hypoglycemic events. Results: Treatment with insulin degludec resulted in a relative rate reduction (RRR) of 36% (95% confidence interval [CI]: 10%–54%; P < 0.05) in nocturnal CGM-recorded hypoglycemia (≤3.9 mmol/L), corresponding to an absolute rate reduction (ARR) of 0.85 events per person-week. In nocturnal CGM-recorded hypoglycemia (≤3.0 mmol/L), we found an RRR of 53% (95% CI: 36%–65%; P < 0.001), corresponding to an ARR of 0.75 events per person-week. At the lower detection limit of the CGM (≤2.2 mmol/L), treatment with insulin degludec resulted in a significant RRR of 58% (95% CI: 23%–77%; P = 0.005). The reductions were primarily due to significant RRRs in asymptomatic hypoglycemia. Conclusion: In people with T1D, prone to nocturnal severe hypoglycemia, insulin degludec compared with insulin glargine U100 significantly reduces nocturnal CGM-recorded hypoglycemia. www.clinicaltrials.gov (#NCT02192450).</description><subject>Asymptomatic</subject><subject>Diabetes</subject><subject>Glucose monitoring</subject><subject>Hypoglycemia</subject><subject>Insulin</subject><issn>1520-9156</issn><issn>1557-8593</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNpdkUtLAzEUhQdRsD6W7gNu3EzNo8nMLKXVKvhC7XpIkzs1JU3GZEbpP_JnmloRdHUvh-8-OCfLTggeElxW59rIIcWUDDEXxU42IJwXeckrtrvpKc4rwsV-dhDjEmNcMEoG2efYu8643vcRTW2vfAR0553pfDBukT-B8kGDRtfr1i_sWsHKSPRhuld042JvjUMTWNheg0I-_GpTK8PCOEAzgjFKwiP41sJ28GXdAiJoYuQcOojoMfhEdh7de9X1wUmLnuEdAvw5epTtNdJGOP6ph9ns6vJlfJ3fPkxvxhe3uWKs6HIxUnNMsZhTKZQGoQUZVbzQgjZKKl1qxkjZYKVEBRWTI0mTREpdNkLSZo7ZYXa23dsG_9ZD7OqViQqslQ6SSTUVnHOR7C4SevoPXfrv_xNV4LIQghCaqHxLqeBjDNDUbTArGdY1wfUmtzrlVm9yqze5sS_cZI27</recordid><startdate>20220901</startdate><enddate>20220901</enddate><creator>Brøsen, Julie Maria Bøggild</creator><creator>Agesen, Rikke Mette</creator><creator>Alibegovic, Amra Ciric</creator><creator>Ullits Andersen, Henrik</creator><creator>Beck-Nielsen, Henning</creator><creator>Gustenhoff, Peter</creator><creator>Krarup Hansen, Troels</creator><creator>Hedetoft, Christoffer Georg Riber</creator><creator>Jensen, Tonny Joran</creator><creator>Stolberg, Charlotte Røn</creator><creator>Bogh Juhl, Claus</creator><creator>Lerche, Susanne Søgaard</creator><creator>Nørgaard, Kirsten</creator><creator>Parving, Hans-Henrik</creator><creator>Tarnow, Lise</creator><creator>Thorsteinsson, Birger</creator><creator>Pedersen-Bjergaard, Ulrik</creator><general>Mary Ann Liebert, Inc</general><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-7361-4407</orcidid><orcidid>https://orcid.org/0000-0002-7649-7928</orcidid></search><sort><creationdate>20220901</creationdate><title>Continuous Glucose Monitoring-Recorded Hypoglycemia with Insulin Degludec or Insulin Glargine U100 in People with Type 1 Diabetes Prone to Nocturnal Severe Hypoglycemia</title><author>Brøsen, Julie Maria Bøggild ; 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Insulin degludec is associated with a lower risk of nocturnal hypoglycemia in T1D. As nocturnal hypoglycemia is often asymptomatic, we applied continuous glucose monitoring (CGM) to detect a more precise occurrence of nocturnal hypoglycemia in the HypoDeg trial, comparing insulin degludec with insulin glargine U100 in people with T1D and previous nocturnal severe hypoglycemia. Materials and Methods: In the HypoDeg trial, 149 people with T1D were included in an open-label randomized cross-over trial. Sixty-seven participants accepted optional participation in the predefined substudy of 4 × 6 days of blinded CGM requiring completion of at least one CGM period in each treatment arm. CGM data were reviewed for hypoglycemic events. Results: Treatment with insulin degludec resulted in a relative rate reduction (RRR) of 36% (95% confidence interval [CI]: 10%–54%; P < 0.05) in nocturnal CGM-recorded hypoglycemia (≤3.9 mmol/L), corresponding to an absolute rate reduction (ARR) of 0.85 events per person-week. In nocturnal CGM-recorded hypoglycemia (≤3.0 mmol/L), we found an RRR of 53% (95% CI: 36%–65%; P < 0.001), corresponding to an ARR of 0.75 events per person-week. At the lower detection limit of the CGM (≤2.2 mmol/L), treatment with insulin degludec resulted in a significant RRR of 58% (95% CI: 23%–77%; P = 0.005). The reductions were primarily due to significant RRRs in asymptomatic hypoglycemia. Conclusion: In people with T1D, prone to nocturnal severe hypoglycemia, insulin degludec compared with insulin glargine U100 significantly reduces nocturnal CGM-recorded hypoglycemia. www.clinicaltrials.gov (#NCT02192450).</abstract><cop>New Rochelle</cop><pub>Mary Ann Liebert, Inc</pub><doi>10.1089/dia.2021.0567</doi><tpages>12</tpages><orcidid>https://orcid.org/0000-0001-7361-4407</orcidid><orcidid>https://orcid.org/0000-0002-7649-7928</orcidid><oa>free_for_read</oa></addata></record> |
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| source | Alma/SFX Local Collection |
| subjects | Asymptomatic Diabetes Glucose monitoring Hypoglycemia Insulin |
| title | Continuous Glucose Monitoring-Recorded Hypoglycemia with Insulin Degludec or Insulin Glargine U100 in People with Type 1 Diabetes Prone to Nocturnal Severe Hypoglycemia |
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