Citations 3
Patient-Reported Outcomes in a Randomized Trial of Closed-Loop Control: The Pivotal International Diabetes Closed-Loop Trial
Kudva, Yogish C. , Laffel, Lori M. , Brown, Sue A. , Raghinaru, Dan, Pinsker, Jordan E. , Ekhlaspour, Laya , Messer, Laurel H. , Kovatchev, Boris , Lum, John W. , Gonder‐Frederick, Linda , Anderson, Stacey M. , Emory, Emma, Voelmle, Mary, Conshafter, Katie, Morris, Kim, Mitchell, Harry, Calvo, Kayla, Wakeman, Christian, Breton, Marc D. , Ambler-Osborn, Louise, Flint, Emily, Kim, Kenny, Roethke, Lindsay, Church, Mei Mei , André, Camille , Piper, Molly, Lam, David W. , O’Malley, Grenye , Levister, Camilla, Ogyaadu, Selassie, Lovett, Jessica, Simha, Vinaya , Dadlani, Vikash, McCrady-Spitzer, Shelly , Reid, Corey, Forlenza, Gregory P. , Alonso, G. Todd, Slover, Robert H., Jost, Emily , Berget, Cari , Towers, Lindsey, Rossick-Solis, Alex, Buckingham, Bruce A. , Jacobson, Tali, Town, Marissa, Tabatabai, Ideen , Keller, Jordan, Salas, Evalina, Dassau, Eyal , Passman, Samantha, Campos, Tiffany, Kollman, Craig, Murphy, Carlos, Patibandla, Nandan, Borgman, Sarah, Arreaza-Rubín, Guillermo , Green, Neal, Reznik, Yves , Janicek, Robert, Gabrielson, Deanna, Belle, Steven H., Castle, Jessica R. , Legault, Laurent , Wysham, Carol , Eggerman, Thomas L., Messer, Laurel H , Lum, John , Forlenza, Gregory P , Kovatchev, Boris , Buckingham, Bruce , Levy, Carol J. , Beck, Roy W. , Oliveri, Mary Clancy , Isganaitis, Elvira , Kumari, Kanchan, Wadwa, R Paul , Doyle, Francis J. , Kollman, Craig , Renard, Eric , Cobelli, Claudio , Green, Jennifer Greif , Willi, Steven Matthew
Diabetes Technology & Therapeutics | June 11, 2021 | Volume: 23 | Issue: 10 | Pages: 673-683
Background: Closed-loop control (CLC) has been shown to improve glucose time in range and other glucose metrics; however, randomized trials >3 months comparing CLC with sensor-augmented pump (SAP) therapy are limited. We recently reported glucose control outcomes from the 6-month international Diabetes Closed-Loop (iDCL) trial; we now report patient-reported outcomes (PROs) in this iDCL trial. Methods: Participants were randomized 2:1 to CLC ( N = 112) versus SAP ( N = 56) and completed questionnaires, including Hypoglycemia Fear Survey, Diabetes Distress Scale (DDS), Hypoglycemia Awareness, Hypoglycemia Confidence, Hyperglycemia Avoidance, and Positive Expectancies of CLC (INSPIRE) at baseline, 3, and 6 months. CLC participants also completed Diabetes Technology Expectations and Acceptance and System Usability Scale (SUS). Results: The Hypoglycemia Fear Survey Behavior subscale improved significantly after 6 months of CLC compared with SAP. DDS did not differ except for powerless subscale scores, which worsened at 3 months in SAP. Whereas Hypoglycemia Awareness and Hyperglycemia Avoidance did not differ between groups, CLC participants showed a tendency toward improved confidence in managing hypoglycemia. The INSPIRE questionnaire showed favorable scores in the CLC group for teens and parents, with a similar trend for adults. At baseline and 6 months, CLC participants had high positive expectations for the device with Diabetes Technology Acceptance and SUS showing high benefit and low burden scores. Conclusion: CLC improved some PROs compared with SAP. Participants reported high benefit and low burden with CLC. Clinical Trial Identifier: NCT03563313.
Closed-Loop Insulin Therapy Improves Glycemic Control in Adolescents and Young Adults: Outcomes from the International Diabetes Closed-Loop Trial
Isganaitis, Elvira , Raghinaru, Dan, Ambler-Osborn, Louise, Pinsker, Jordan E. , Buckingham, Bruce A. , Ekhlaspour, Laya , Kudva, Yogish C., Forlenza, Gregory P. , Beck, Roy W., Kollman, Craig, Lum, John W. , Brown, Sue A. , Laffel, Lori M. , Kovatchev, Boris, Anderson, Stacey, Emory, Emma, Voelmle, Mary, Conshafter, Katie, Morris, Kim, Gondor-Fredrick, Linda, Mitchell, Harry, Calvo, Kayla, Wakeman, Christian, Breton, Marc, Flint, Emily, Kim, Kenny, Roethke, Lindsay, Church, Mei Mei , André, Camille , Piper, Molly, Lam, David , O’Malley, Grenye , Levister, Camilla, Ogyaadu, Selassie, Lovett, Jessica, Simha, Vinaya , Dadlani, Vikash, McCrady-Spitzer, Shelly , Reid, Corey, Alonso, G. Todd, Slover, Robert H., Jost, Emily , Berget, Cari, Towers, Lindsey, Rossick-Solis, Alex, Jacobson, Tali, Town, Marissa, Tabatabai, Ideen , Keller, Jordan, Salas, Evalina, Dassau, Eyal , Passman, Samantha, Campos, Tiffany, Murphy, Carlos, Patibandla, Nandan, Borgman, Sarah, Arreaza-Rubín, Guillermo , Green, Neal, Laffel, Lori, Pinsker, Jordan, Doyle, Francis, Renard, Eric, Reznik, Yves , Lum, John, Janicek, Robert, Gabrielson, Deanna, Belle, Steven H., Castle, Jessica R. , Green, Jennifer , Legault, Laurent , Wysham, Carol , Eggerman, Thomas, Forlenza, Gregory P , Buckingham, Bruce , Wadwa, R Paul , Kudva, Yogish C. , Levy, Carol J. , Kollman, Craig , Kovatchev, Boris , Anderson, Stacey M. , Oliveri, Mary Clancy , Kumari, Kanchan , Messer, Laurel H , Jacobson, Tali, Doyle, Francis J. , Patibandla, Nandan, Laffel, Lori M. , Cobelli, Claudio , Beck, Roy W. , Willi, Steven Matthew
Diabetes Technology & Therapeutics | November 20, 2020 | Volume: 23 | Issue: 5 | Pages: 342-349
Objective: To assess the efficacy and safety of closed-loop control (CLC) insulin delivery system in adolescents and young adults with type 1 diabetes. Research Design and Methods: Prespecified subanalysis of outcomes in adolescents and young adults aged 14–24 years old with type 1 diabetes in a previously published 6-month multicenter randomized trial. Participants were randomly assigned 2:1 to CLC (Tandem Control-IQ) or sensor augmented pump (SAP, various pumps+Dexcom G6 CGM) and followed for 6 months. Results: Mean age of the 63 participants was 17 years, median type 1 diabetes duration was 7 years, and mean baseline HbA1c was 8.1%. All 63 completed the trial. Time in range (TIR) increased by 13% with CLC versus decreasing by 1% with SAP (adjusted treatment group difference = +13% [+3.1 h/day]; 95% confidence interval [CI] 9–16, P < 0.001), which largely reflected a reduction in time >180 mg/dL (adjusted difference −12% [−2.9 h/day], P < 0.001). Time <70 mg/dL decreased by 1.6% with CLC versus 0.3% with SAP (adjusted difference −0.7% [−10 min/day], 95% CI −1.0% to −0.2%, P = 0.002). CLC use averaged 89% of the time for 6 months. The mean adjusted difference in HbA1c after 6 months was 0.30% in CLC versus SAP (95% CI −0.67 to +0.08, P = 0.13). There was one diabetic ketoacidosis episode in the CLC group. Conclusions: CLC use for 6 months was substantial and associated with improved TIR and reduced hypoglycemia in adolescents and young adults with type 1 diabetes. Thus, CLC has the potential to improve glycemic outcomes in this challenging age group. The clinical trial was registered with ClinicalTrials.gov (NCT03563313).
Clinical Management and Pump Parameter Adjustment of the Control-IQ Closed-Loop Control System: Results from a 6-Month, Multicenter, Randomized Clinical Trial
O’Malley, Grenye , Messer, Laurel H. , Pinsker, Jordan E. , Forlenza, Gregory P. , Isganaitis, Elvira , Kudva, Yogish C. , Ekhlaspour, Laya , Raghinaru, Dan, Lum, John W. , Brown, Sue A. , Kovatchev, Boris, Anderson, Stacey M. , Emory, Emma, Voelmle, Mary, Conshafter, Katie, Morris, Kim, Gondor-Fredrick, Linda, Mitchell, Harry, Calvo, Kayla, Wakeman, Christian, Breton, Marc D. , Laffel, Lori M. , E.I., Ambler-Osborn, Louise, Flint, Emily, Kim, Kenny, Roethke, Lindsay, J.E.P., Church, Mei Mei , André, Camille , Piper, Molly, C.J.L., Lam, David W. , G.O., Levister, Camilla, Ogyaadu, Selassie, Lovett, Jessica, Simha, Vinaya , Dadlani, Vikash, McCrady-Spitzer, Shelly , Reid, Corey, Wadwa, R. Paul, Alonso, G. Todd, Slover, Robert H., Jost, Emily , L.H.M., Berget, Cari, Towers, Lindsey, Rossick-Solis, Alex, Buckingham, Bruce, L.E., Jacobson, Tali, Town, Marissa, Tabatabai, Ideen , Keller, Jordan, Salas, Evalina, Paulson, John A., Beck, Jan-Philipp, Passman, Samantha, Campos, Tiffany, Kollman, D.R. Craig, Murphy, Carlos, Patibandla, Nandan, Borgman, Sarah, Arreza-Rubin, Guillermo, Eggerman, Thomas L., Green, Neal, Kovatchev, Boris, Arreza-Rubin, Guillermo, J.E.P., C.J.L., Y.C.K., Wadwa, R. Paul, Reznik, Yves , Arreza-Rubin, Guillermo, Buckingham, Bruce A. , Forlenza, Gregory P , Messer, Laurel H , Buckingham, Bruce , Levy, Carol J. , Pinsker, Jordan E. , Kovatchev, Boris , Kovatchev, Boris, Oliveri, Mary Clancy , E.I., J.E.P., C.J.L., G.O., Wadwa, R Paul , Kumari, Kanchan , Wadwa, R. Paul, L.H.M., L.E., Town, Marissa, Paulson, John A., Patibandla, Nandan, Arreza-Rubin, Guillermo, Kovatchev, Boris, Arreza-Rubin, Guillermo, J.E.P., C.J.L., Y.C.K., Wadwa, R. Paul, Renard, Eric , Cobelli, Claudio , Arreza-Rubin, Guillermo
Diabetes Technology & Therapeutics | November 6, 2020 | Volume: 23 | Issue: 4 | Pages: 245-252
Background: Data are limited on the need for and benefits of pump setting optimization with automated insulin delivery. We examined clinical management of a closed-loop control (CLC) system and its relationship to glycemic outcomes. Materials and Methods: We analyzed personal parameter adjustments in 168 participants in a 6-month multicenter trial of CLC with Control-IQ versus sensor-augmented pump (SAP) therapy. Preset parameters (BR = basal rates, CF = correction factors, CR = carbohydrate ratios) were optimized at randomization, 2 and 13 weeks, for safety issues, participant concerns, or initiation by participants' usual diabetes care team. Time in range (TIR 70–180 mg/dL) was compared in the week before and after parameter changes. Results: In 607 encounters for parameter changes, there were fewer adjustments for CLC than SAP (3.4 vs. 4.1/participant). Adjustments involved BR (CLC 69%, SAP 80%), CR (CLC 68%, SAP 50%), CF (CLC 44%, SAP 41%), and overnight parameters (CLC 62%, SAP 75%). TIR before and after adjustments was 71.2% and 71.3% for CLC and 61.0% and 62.9% for SAP. The highest baseline HbA 1c CLC subgroup had the largest TIR improvement (51.2% vs. 57.7%). When a CR was made more aggressive in the CLC group, postprandial time >180 mg/dL was 43.1% before the change and 36.0% after the change. The median postprandial time <70 mg/dL before making CR less aggressive was 1.8%, and after the change was 0.7%. Conclusions: No difference in TIR was detected with parameter changes overall, but they may have an effect in higher HbA 1c subgroups or following user-directed boluses, suggesting that changes may matter more in suboptimal control or during discrete periods of the day. Clinical Trials Registration number: NCT03563313.