Effect of 48 Months of Closed-Loop Insulin Delivery on Residual C-Peptide Secretion and Glycemic Control in Newly Diagnosed Youth With Type 1 Diabetes: A Randomized Trial

We evaluated the effect of long-term intensive metabolic control with hybrid closed-loop (CL) on residual C-peptide secretion and glucose control compared with standard insulin therapy in youth with type 1 diabetes over 48 months. Following the 24-month primary phase of a multicenter, randomized, pa...

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Published inDiabetes care Vol. 47; no. 8; pp. 1441 - 1448
Main Authors Ware, Julia, Boughton, Charlotte K, Allen, Janet M, Wilinska, Malgorzata E, Hartnell, Sara, Thankamony, Ajay, Randell, Tabitha, Ghatak, Atrayee, Besser, Rachel E J, Elleri, Daniela, Trevelyan, Nicola, Campbell, Fiona M, Sibayan, Judy, Bailey, Ryan, Calhoun, Peter, Dunseath, Gareth, Hovorka, Roman
Format Journal Article
LanguageEnglish
Published United States American Diabetes Association 01.08.2024
Subjects
Adolescent
Algorithms
Blood Glucose - drug effects
Blood Glucose - metabolism
C-Peptide - blood
Child
Closed loops
Design standards
Diabetes
Diabetes mellitus (insulin dependent)
Diabetes Mellitus, Type 1 - blood
Diabetes Mellitus, Type 1 - drug therapy
Diabetes Mellitus, Type 1 - metabolism
Diagnosis
Fasting
Female
Glucose
Glycated Hemoglobin - metabolism
Glycemic Control - methods
Humans
Hypoglycemic Agents - administration & dosage
Hypoglycemic Agents - therapeutic use
Insulin
Insulin - administration & dosage
Insulin - therapeutic use
Insulin Infusion Systems
Ketoacidosis
Male
Peptides
Randomization
Research design
Secretion
Therapy
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Abstract We evaluated the effect of long-term intensive metabolic control with hybrid closed-loop (CL) on residual C-peptide secretion and glucose control compared with standard insulin therapy in youth with type 1 diabetes over 48 months. Following the 24-month primary phase of a multicenter, randomized, parallel trial of 96 newly diagnosed youth aged 10 to 16.9 years, participants were invited to an extension phase using treatment allocated at randomization. They continued with hybrid CL using the Cambridge algorithm or standard insulin therapy (control) until 48 months after diagnosis. Analysis was by intention-to-treat. At 24 months after diagnosis, 81 participants (mean ± SD age 14 ± 2 years) continued in the extension phase (47 CL, 34 control). There was no difference in fasting C-peptide corrected for fasting glucose at 48 months between groups (CL: 5 ± 9 vs. control: 6 ± 14 pmol/L per mmol/L; mean adjusted difference -2 [95% CI -7, 4; P = 0.54]). Central laboratory HbA1c remained lower in the CL group by 0.9% (10 mmol/mol [95% CI 0.2, 1.5; 3, 17 mmol/mol); P = 0.009). Time in target range of 3.9 to 10.0 mmol/L was 12 percentage points (95% CI 3, 20; P = 0.008) higher in the CL group compared with control. There were 11 severe hypoglycemic events (6 CL, 5 control) and 7 diabetic ketoacidosis events (3 CL, 4 control) during the extension phase. Improved glycemic control was sustained over 48 months after diagnosis with CL insulin delivery compared with standard therapy in youth with type 1 diabetes. This did not appear to confer a protective effect on residual C-peptide secretion.
AbstractList We evaluated the effect of long-term intensive metabolic control with hybrid closed-loop (CL) on residual C-peptide secretion and glucose control compared with standard insulin therapy in youth with type 1 diabetes over 48 months.OBJECTIVEWe evaluated the effect of long-term intensive metabolic control with hybrid closed-loop (CL) on residual C-peptide secretion and glucose control compared with standard insulin therapy in youth with type 1 diabetes over 48 months.Following the 24-month primary phase of a multicenter, randomized, parallel trial of 96 newly diagnosed youth aged 10 to 16.9 years, participants were invited to an extension phase using treatment allocated at randomization. They continued with hybrid CL using the Cambridge algorithm or standard insulin therapy (control) until 48 months after diagnosis. Analysis was by intention-to-treat.RESEARCH DESIGN AND METHODSFollowing the 24-month primary phase of a multicenter, randomized, parallel trial of 96 newly diagnosed youth aged 10 to 16.9 years, participants were invited to an extension phase using treatment allocated at randomization. They continued with hybrid CL using the Cambridge algorithm or standard insulin therapy (control) until 48 months after diagnosis. Analysis was by intention-to-treat.At 24 months after diagnosis, 81 participants (mean ± SD age 14 ± 2 years) continued in the extension phase (47 CL, 34 control). There was no difference in fasting C-peptide corrected for fasting glucose at 48 months between groups (CL: 5 ± 9 vs. control: 6 ± 14 pmol/L per mmol/L; mean adjusted difference -2 [95% CI -7, 4; P = 0.54]). Central laboratory HbA1c remained lower in the CL group by 0.9% (10 mmol/mol [95% CI 0.2, 1.5; 3, 17 mmol/mol); P = 0.009). Time in target range of 3.9 to 10.0 mmol/L was 12 percentage points (95% CI 3, 20; P = 0.008) higher in the CL group compared with control. There were 11 severe hypoglycemic events (6 CL, 5 control) and 7 diabetic ketoacidosis events (3 CL, 4 control) during the extension phase.RESULTSAt 24 months after diagnosis, 81 participants (mean ± SD age 14 ± 2 years) continued in the extension phase (47 CL, 34 control). There was no difference in fasting C-peptide corrected for fasting glucose at 48 months between groups (CL: 5 ± 9 vs. control: 6 ± 14 pmol/L per mmol/L; mean adjusted difference -2 [95% CI -7, 4; P = 0.54]). Central laboratory HbA1c remained lower in the CL group by 0.9% (10 mmol/mol [95% CI 0.2, 1.5; 3, 17 mmol/mol); P = 0.009). Time in target range of 3.9 to 10.0 mmol/L was 12 percentage points (95% CI 3, 20; P = 0.008) higher in the CL group compared with control. There were 11 severe hypoglycemic events (6 CL, 5 control) and 7 diabetic ketoacidosis events (3 CL, 4 control) during the extension phase.Improved glycemic control was sustained over 48 months after diagnosis with CL insulin delivery compared with standard therapy in youth with type 1 diabetes. This did not appear to confer a protective effect on residual C-peptide secretion.CONCLUSIONSImproved glycemic control was sustained over 48 months after diagnosis with CL insulin delivery compared with standard therapy in youth with type 1 diabetes. This did not appear to confer a protective effect on residual C-peptide secretion.
We evaluated the effect of long-term intensive metabolic control with hybrid closed-loop (CL) on residual C-peptide secretion and glucose control compared with standard insulin therapy in youth with type 1 diabetes over 48 months. Following the 24-month primary phase of a multicenter, randomized, parallel trial of 96 newly diagnosed youth aged 10 to 16.9 years, participants were invited to an extension phase using treatment allocated at randomization. They continued with hybrid CL using the Cambridge algorithm or standard insulin therapy (control) until 48 months after diagnosis. Analysis was by intention-to-treat. At 24 months after diagnosis, 81 participants (mean ± SD age 14 ± 2 years) continued in the extension phase (47 CL, 34 control). There was no difference in fasting C-peptide corrected for fasting glucose at 48 months between groups (CL: 5 ± 9 vs. control: 6 ± 14 pmol/L per mmol/L; mean adjusted difference -2 [95% CI -7, 4; P = 0.54]). Central laboratory HbA1c remained lower in the CL group by 0.9% (10 mmol/mol [95% CI 0.2, 1.5; 3, 17 mmol/mol); P = 0.009). Time in target range of 3.9 to 10.0 mmol/L was 12 percentage points (95% CI 3, 20; P = 0.008) higher in the CL group compared with control. There were 11 severe hypoglycemic events (6 CL, 5 control) and 7 diabetic ketoacidosis events (3 CL, 4 control) during the extension phase. Improved glycemic control was sustained over 48 months after diagnosis with CL insulin delivery compared with standard therapy in youth with type 1 diabetes. This did not appear to confer a protective effect on residual C-peptide secretion.
OBJECTIVE We evaluated the effect of long-term intensive metabolic control with hybrid closed-loop (CL) on residual C-peptide secretion and glucose control compared with standard insulin therapy in youth with type 1 diabetes over 48 months. RESEARCH DESIGN AND METHODS Following the 24-month primary phase of a multicenter, randomized, parallel trial of 96 newly diagnosed youth aged 10 to 16.9 years, participants were invited to an extension phase using treatment allocated at randomization. They continued with hybrid CL using the Cambridge algorithm or standard insulin therapy (control) until 48 months after diagnosis. Analysis was by intention-to-treat. RESULTS At 24 months after diagnosis, 81 participants (mean ± SD age 14 ± 2 years) continued in the extension phase (47 CL, 34 control). There was no difference in fasting C-peptide corrected for fasting glucose at 48 months between groups (CL: 5 ± 9 vs. control: 6 ± 14 pmol/L per mmol/L; mean adjusted difference −2 [95% CI −7, 4; P = 0.54]). Central laboratory HbA1c remained lower in the CL group by 0.9% (10 mmol/mol [95% CI 0.2, 1.5; 3, 17 mmol/mol); P = 0.009). Time in target range of 3.9 to 10.0 mmol/L was 12 percentage points (95% CI 3, 20; P = 0.008) higher in the CL group compared with control. There were 11 severe hypoglycemic events (6 CL, 5 control) and 7 diabetic ketoacidosis events (3 CL, 4 control) during the extension phase. CONCLUSIONS Improved glycemic control was sustained over 48 months after diagnosis with CL insulin delivery compared with standard therapy in youth with type 1 diabetes. This did not appear to confer a protective effect on residual C-peptide secretion.
Author Thankamony, Ajay
Trevelyan, Nicola
Hovorka, Roman
Boughton, Charlotte K
Bailey, Ryan
Calhoun, Peter
Elleri, Daniela
Campbell, Fiona M
Dunseath, Gareth
Sibayan, Judy
Randell, Tabitha
Ghatak, Atrayee
Besser, Rachel E J
Hartnell, Sara
Wilinska, Malgorzata E
Ware, Julia
Allen, Janet M
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de Barros Tamarozzi, Mirela
Dunger, David
Allen, Janet
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Copyright 2024 by the American Diabetes Association.
Copyright American Diabetes Association Aug 2024
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PublicationTitle Diabetes care
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References Abraham (2024072518510861100_B17) 2021; 175
Shah (2024072518510861100_B11) 1989; 320
Foster (2024072518510861100_B4) 2019; 21
Zeng (2024072518510861100_B27) 2023; 46
2024072518510861100_B5
Boughton (2024072518510861100_B19) 2022; 387
McVean (2024072518510861100_B26) 2023; 329
Rankin (2024072518510861100_B21) 2020; 15
Ware (2024072518510861100_B13) 2022; 4
Todd (2024072518510861100_B1) 2010; 32
Diabetes Control Complications Trial/Epidemiology of Diabetes Interventions Complications Study Research Group (2024072518510861100_B8) 2016; 39
Steffes (2024072518510861100_B10) 2003; 26
Breton (2024072518510861100_B14) 2020; 383
Ward (2024072518510861100_B3) 2022; 10
Gerhardsson (2024072518510861100_B6) 2021; 23
Buckingham (2024072518510861100_B12) 2013; 36
Ghatak (2024072518510861100_B28) 2023; 25
2024072518510861100_B22
Lakshman (2024072518510861100_B25) 2024; 26
Rankin (2024072518510861100_B20) 2021; 18
Lachin (2024072518510861100_B9) 2014; 63
Bergenstal (2024072518510861100_B16) 2021; 397
Messer (2024072518510861100_B18) 2022; 24
Brown (2024072518510861100_B15) 2019; 381
Duca (2024072518510861100_B23) 2017; 40
Fredheim (2024072518510861100_B24) 2013; 56
Patterson (2024072518510861100_B2) 2019; 157
Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Group. (2024072518510861100_B7) 2016; 39
2024072518510861100_B29
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Snippet We evaluated the effect of long-term intensive metabolic control with hybrid closed-loop (CL) on residual C-peptide secretion and glucose control compared with...
OBJECTIVE We evaluated the effect of long-term intensive metabolic control with hybrid closed-loop (CL) on residual C-peptide secretion and glucose control...
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StartPage 1441
SubjectTerms Adolescent
Algorithms
Blood Glucose - drug effects
Blood Glucose - metabolism
C-Peptide - blood
Child
Closed loops
Design standards
Diabetes
Diabetes mellitus (insulin dependent)
Diabetes Mellitus, Type 1 - blood
Diabetes Mellitus, Type 1 - drug therapy
Diabetes Mellitus, Type 1 - metabolism
Diagnosis
Fasting
Female
Glucose
Glycated Hemoglobin - metabolism
Glycemic Control - methods
Humans
Hypoglycemic Agents - administration & dosage
Hypoglycemic Agents - therapeutic use
Insulin
Insulin - administration & dosage
Insulin - therapeutic use
Insulin Infusion Systems
Ketoacidosis
Male
Peptides
Randomization
Research design
Secretion
Therapy
Title Effect of 48 Months of Closed-Loop Insulin Delivery on Residual C-Peptide Secretion and Glycemic Control in Newly Diagnosed Youth With Type 1 Diabetes: A Randomized Trial
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