Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Ware, J; Allen, JM; Boughton, CK; Wilinska, ME; Hartnell, S; Thankamony, A; de, Beaufort, C; Campbell, FM; Fröhlich-Reiterer, E; Fritsch, M; Hofer, SE; Kapellen, TM; Rami-Merhar, B; Tauschmann, M; Hovorka, R, , KidsAP, Consortium
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Eighteen-Month Hybrid Closed-Loop Use in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Trial.
Diabetes Care. 2024; 47(12):2189-2195
Doi: 10.2337/dc24-1313
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Web of Science
PubMed
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- Co-Autor*innen der Med Uni Graz
- Fritsch Maria
- Fröhlich-Reiterer Elke
- Tauschmann Martin
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- Abstract:
- OBJECTIVE: We aimed to evaluate the longer-term safety and efficacy of hybrid closed-loop (CL) therapy in very young children with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: Following a 16-week multinational, randomized crossover trial comparing hybrid CL with sensor-augmented pump (SAP) therapy in 74 very young children aged 1-7 years with T1D, participants were invited to an extension phase using CL for a further 18 months. Outcomes were compared with the primary-phase SAP period and primary-phase CL period. RESULTS: After the primary study phase, 60 participants were eligible to enroll in the extension. Of these, 49 consented (mean ± SD age 6.6 ± 1.5 years) to continue use of CL for 18 months. Percentage time in range (TIR) 3.9-10.0 mmol/L was 8.4 percentage points (95% CI 6.7-10.1; P < 0.001) higher, while HbA1c was 0.4% ([5.0 mmol/mol], 95% CI 0.3-0.6 [3.7-6.2]; P < 0.001) lower during the CL extension phase compared with primary-phase SAP period. At 18 months, mean HbA1c was 6.7 ± 0.5% and TIR was 70 ± 7%, compared with 6.7 ± 0.5% and 71 ± 6% in the primary-phase CL period. Time in hypoglycemia (<3.9 mmol/L) was similar between CL extension phase and both primary-phase SAP (P = 0.31) and CL periods (P = 0.70). There were two severe hypoglycemia events and one other serious adverse event during the extension phase. One unexpected serious adverse device effect occurred. CONCLUSIONS: Use of the Cambridge hybrid CL system led to sustained improvements in glycemic control lasting more than 18 months in very young children with T1D.
- Find related publications in this database (using NLM MeSH Indexing)
- Humans - administration & dosage
- Diabetes Mellitus, Type 1 - drug therapy, blood
- Child, Preschool - administration & dosage
- Male - administration & dosage
- Female - administration & dosage
- Insulin Infusion Systems - administration & dosage
- Infant - administration & dosage
- Child - administration & dosage
- Cross-Over Studies - administration & dosage
- Blood Glucose - drug effects
- Hypoglycemic Agents - administration & dosage, therapeutic use
- Insulin - administration & dosage, therapeutic use