Back to Search
Start Over
Patient-Reported Outcomes in a Randomized Trial of Closed-Loop Control: The Pivotal International Diabetes Closed-Loop Trial.
- Source :
-
Diabetes Technology & Therapeutics . Oct2021, Vol. 23 Issue 10, p673-683. 11p. - Publication Year :
- 2021
-
Abstract
- 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 (Nā=ā112) versus SAP (Nā=ā56) 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. [ABSTRACT FROM AUTHOR]
- Subjects :
- *DIABETES
*HYPOGLYCEMIA
*ADULTS
*HYPERGLYCEMIA
*CHILD care workers
Subjects
Details
- Language :
- English
- ISSN :
- 15209156
- Volume :
- 23
- Issue :
- 10
- Database :
- Academic Search Index
- Journal :
- Diabetes Technology & Therapeutics
- Publication Type :
- Academic Journal
- Accession number :
- 152889407
- Full Text :
- https://doi.org/10.1089/dia.2021.0089