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Randomized Controlled Trial
. 2021 Jun;23(6):401-409.
doi: 10.1089/dia.2020.0532. Epub 2021 Jan 28.

Health-Related Quality of Life and Treatment Satisfaction in Parents and Children with Type 1 Diabetes Using Closed-Loop Control

Erin C Cobry  1 , Lauren G Kanapka  2 , Eda Cengiz  3 , Lori Carria  3 , Laya Ekhlaspour  4 , Bruce A Buckingham  4 , Korey K Hood  4 , Liana J Hsu  4 , Laurel H Messer  1 , Melissa J Schoelwer  5 , Emma Emory  5 , Katrina J Ruedy  2 , Roy W Beck  1 , Raj Paul Wadwa  1 , Linda Gonder-Frederick  5 ; iDCL Trial Research Group
Collaborators, Affiliations
Randomized Controlled Trial

Health-Related Quality of Life and Treatment Satisfaction in Parents and Children with Type 1 Diabetes Using Closed-Loop Control

Erin C Cobry et al. Diabetes Technol Ther. 2021 Jun.

Abstract

Introduction: Hybrid closed-loop systems increase time-in-range (TIR) and reduce glycemic variability. Person-reported outcomes (PROs) are essential to assess the utility of new devices and their impact on quality of life. This article focuses on the PROs for pediatric participants (ages 6-13 years) with type 1 diabetes (T1D) and their parents during a trial using the Tandem Control-IQ system, which was shown to increase TIR and improve other glycemic metrics. Research Design and Methods: One hundred and one children 6 to 13 years old with T1D were randomly assigned to closed-loop control (CLC) or sensor-augmented pump (SAP) in a 16-week randomized clinical trial with extension to 28 weeks during which the SAP group crossed over to CLC. Health-related quality of life and treatment satisfaction measures were obtained from children and their parents at baseline, 16 weeks, and 28 weeks. Results: Neither the children in the CLC group nor their parents had statistically significant changes in PRO outcomes compared with the SAP group at the end of the 16-week randomized controlled trial and the 28-week extension. Parents in the CLC group reported nonsignificant improvements in some PRO scores when compared with the SAP group at 16 weeks, which were sustained at 28 weeks. Sleep scores for parents improved from "poor sleep quality" to "adequate sleep quality" between baseline and 16 weeks, however, the change in scores was not statistically different between groups. Conclusions: Children with T1D who used the Control-IQ system did not experience increased burden compared with those using SAP based on person-reported outcomes from the children and their parents. Clinical Trials Registration: NCT03844789.

Keywords: Closed-loop systems; Continuous glucose monitoring; Hypoglycemic fear; Person-reported outcomes; Quality of life; Sensor augmented insulin pump; Time in range; Type 1 diabetes.

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Conflict of interest statement

E.C.C., L.G.K., E.C., L.C., and E.E. have no relevant disclosures to report. L.E. reports receiving consultancy fees from Tandem Diabetes Care. B.A.B. reports receiving donated supplies from Dexcom, grant support paid to Stanford from Tandem, Medtronic, Convatec, Insulet, and Lilly, and personal fees from Medtronic Diabetes, Convatec, Profusa, and Novo-Nordisk, Tandem, Insulet, Tolerion, and Profusa and holding patent 61197230 issued. K.K.H. received support from Dexcom, Inc for an investigator-initiated study and consultant fees from Lifescan Diabetes Institute, Cecelia Health, and Cercacor.

L.J.H. reports owning stock in Dexcom and Tandem Diabetes Care. L.H.M. has received speaking/consulting honoraria from Tandem Diabetes, DexCom, Inc., and Capillary Biomedical. Her institution receives research grants from Medtronic, Tandem Diabetes, DexCom, Abbott, and Insulet Corp. M.J.S. reports receiving grant support, paid to University of Virginia, from Medtronic and Tandem Diabetes Care during conduct of study and grant support from Insulet, paid to University of Virginia beginning at time of submission. K.J.R. reports receiving grant support and donated supplies, paid to the Jaeb Center for Health Research, from Abbott Diabetes Care, Beta Bionics, and Dexcom, and grant support, paid to the Jaeb Center for Health Research, from Tandem Diabetes Care. R.W.B. reports receiving grant support and donated supplies, paid to the Jaeb Center for Health Research, from Abbott Diabetes Care, Ascensia Diabetes Care US, Beta Bionics, Novo Nordisk, Roche Diabetes Care, and Tandem Diabetes Care; grant support, donated supplies, and consulting fees, paid to the Jaeb Center for Health Research from Dexcom; and consulting fees, paid to the Jaeb Center for Health Research from Bigfoot Biomedical, Eli Lilly and Company, and Insulet Corporation. R.P.W. reports receiving grant support, paid to University of Colorado, from Dexcom, Eli Lilly, and MannKind Corporation and advisory board fees from Eli Lilly and Company and grant support, paid to University of Colorado, and travel support and lecture fees from Tandem Diabetes Care. L.G.-F. reports receiving consulting/speaking fees from Abbott Diabetes Care, Astrazeneca, Dexcom, Johnson and Johnson, and Merck. L.G.-F. also has been licensed by the University of Virginia to form an LLC to distribute and charge licensing fees for the use of the Hypoglycemia Fear Survey in studies conducted by for-profit entities including pharmaceutical companies. However, there were no licensing fees involved for the use of the survey in this study. The survey is always available to use free of costs to nonprofit entities.

Figures

FIG. 1.
FIG. 1.
Boxplots of parent questionnaires by treatment group and visit*. *The 16- and 28-week timepoints represent the end of the randomized clinical trial and extension phase, respectively. During the extension phase, both treatment groups were using the CLC system. Parent version of the Pediatric Hypoglycemia Fear survey (PHFS Total), Problem Areas in Diabetes Survey (PAID), Pediatric Quality of Life (PedsQL Total), Pittsburgh Sleep Quality Index (PSQI). Dark gray represents Tandem Control-IQ system (CLC) cohort, light gray represents SAP cohort, and striped lines represent SAP cross over to CLC. CLC, closed-loop control; SAP, sensor-augmented pump.
FIG. 2.
FIG. 2.
Boxplots of child questionnaires by treatment group and visit*. *The 16- and 28-week timepoints represent the end of the randomized clinical trial and extension phase, respectively. During the extension phase both treatment groups were using the CLC system. Child version of the Pediatric Hypoglycemia Fear Survey (CHFS Total), Problem Areas in Diabetes Survey (PAID), Pediatric Quality of Life (PedsQL Total). Dark gray represents Tandem Control-IQ system (CLC) cohort, light gray represents SAP cohort, and striped lines represent SAP crossover to CLC.
See this image and copyright information in PMC

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