Trial reportDiabetes care2016
Day-and-Night Hybrid Closed-Loop Insulin Delivery in Adolescents With Type 1 Diabetes: A Free-Living, Randomized Clinical Trial.
Trial report in Diabetes care, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 70 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-label, Single-centre, Randomised, Two-period Crossover Study to Assess the Efficacy, Safety and Utility of Automated Closed-loop Glucose Control, Day and Night Over 7 Days (Phase 1) and 21 Days (Phase 2) in Comparison With Continuous Subcutaneous Insulin Infusion Combined With Continuous Glucose Monitoring in the Home Setting in Children and Adolescents T1D
An Open-label, Multicentre, Randomised, Single-period, Parallel Design Study to Assess the Effect of Closed Loop Insulin Delivery From Onset of Type 1 Diabetes in Youth on Residual Beta Cell Function Compared to Standard Insulin Therapy
An Open-label, Multi-centre, Randomised, 2-period Cross-over Study to Assess the Efficacy and Safety of Closed Loop Insulin Delivery Using Diluted Insulin in Comparison With Closed Loop With Non-diluted Insulin Over 21 Days in Children With Type 1 Diabetes Aged 1 to 7 Years in the Home Setting
Day and Night Closed-Loop Glycemic Control With Faster-Acting Insulin Aspart in Young Adults With Type 1 Diabetes Using DreaMed Glucositter - The Fast PHYSI-DREAM Study
Open-label, Multi-centre, Multi-national, Randomized 2-period Crossover Study Comparing Closed-loop Insulin Delivery With Sensor-augmented Pump Therapy Over 4 Months in Children 1-7 Years With Type 1 Diabetes at Home, With an Extension.
Who cites it
70 citing papers in PubMed, 4 syntheses or guidelines pooled it, 125 citations in OpenAlex.
- Hybrid closed-loop systems for managing blood glucose levels in type 1 diabetes: a systematic review and economic modelling.Health technology assessment (Winchester, England) · 2024Pooled it
- Efficacy and safety of closed-loop control system for type one diabetes in adolescents a meta analysis.Scientific reports · 2023Pooled it
- A systematic review: Cost-effectiveness of continuous glucose monitoring compared to self-monitoring of blood glucose in type 1 diabetes.Endocrinology, diabetes & metabolism · 2022Pooled it
- Artificial pancreas treatment for outpatients with type 1 diabetes: systematic review and meta-analysis.BMJ (Clinical research ed.) · 2018Pooled it
- Hybrid closed-loop glucose control compared with sensor augmented pump therapy in older adults with type 1 diabetes: an open-label multicentre, multinational, randomised, crossover study.The lancet. Healthy longevity · 2022Trial
- Safety and Performance of the Omnipod Hybrid Closed-Loop System in Adults, Adolescents, and Children with Type 1 Diabetes Over 5 Days Under Free-Living Conditions.Diabetes technology & therapeutics · 2020Trial
- Feasibility Studies of an Insulin-Only Bionic Pancreas in a Home-Use Setting.Journal of diabetes science and technology · 2019Trial
- Hybrid Closed-Loop Control Is Safe and Effective for People with Type 1 Diabetes Who Are at Moderate to High Risk for Hypoglycemia.Diabetes technology & therapeutics · 2019Trial
- First Look at Control-IQ: A New-Generation Automated Insulin Delivery System.Diabetes care · 2018Trial
- Optimizing Hybrid Closed-Loop Therapy in Adolescents and Emerging Adults Using the MiniMed 670G System.Diabetes care · 2018Trial
- Bolusing frequency and amount impacts glucose control during hybrid closed-loop.Diabetic medicine : a journal of the British Diabetic Association · 2018Trial
- Trial
- Outpatient Closed-Loop Control with Unannounced Moderate Exercise in Adolescents Using Zone Model Predictive Control.Diabetes technology & therapeutics · 2017Trial
- Sensor Life and Overnight Closed Loop: A Randomized Clinical Trial.Journal of diabetes science and technology · 2017Trial
- Day-and-night glycaemic control with closed-loop insulin delivery versus conventional insulin pump therapy in free-living adults with well controlled type 1 diabetes: an open-label, randomised, crossover study.The lancet. Diabetes & endocrinology · 2017Trial
- Home use of a bihormonal bionic pancreas versus insulin pump therapy in adults with type 1 diabetes: a multicentre randomised crossover trial.Lancet (London, England) · 2017Trial
- Home Use of Day-and-Night Hybrid Closed-Loop Insulin Delivery in Suboptimally Controlled Adolescents With Type 1 Diabetes: A 3-Week, Free-Living, Randomized Crossover Trial.Diabetes care · 2016Trial
- Mitigating Meal-Related Glycemic Excursions in an Insulin-Sparing Manner During Closed-Loop Insulin Delivery: The Beneficial Effects of Adjunctive Pramlintide and Liraglutide.Diabetes care · 2016Trial
- Randomized Crossover Comparison of Personalized MPC and PID Control Algorithms for the Artificial Pancreas.Diabetes care · 2016Trial
- Correlation Among Hypoglycemia, Glycemic Variability, and C-Peptide Preservation After Alefacept Therapy in Patients with Type 1 Diabetes Mellitus: Analysis of Data from the Immune Tolerance Network T1DAL Trial.Clinical therapeutics · 2016Trial
10 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 2 institutions in 2 countries.
Funding
Abstract
objectiveTo evaluate feasibility, safety, and efficacy of day-and-night hybrid closed-loop insulin delivery in adolescents with type 1 diabetes under free-living conditions without remote monitoring or supervision. RESEARCH DESIGN AND
methodsIn an open-label, randomized, free-living, crossover study design, 12 adolescents receiving insulin pump therapy (mean [±SD] age 15.4 ± 2.6 years; HbA1c 8.3 ± 0.9%; duration of diabetes 8.2 ± 3.4 years) underwent two 7-day periods of sensor-augmented insulin pump therapy or hybrid closed-loop insulin delivery without supervision or remote monitoring. During the closed-loop insulin delivery, a model predictive algorithm automatically directed insulin delivery between meals and overnight; prandial boluses were administered by participants using a bolus calculator.
resultsThe proportion of time when the sensor glucose level was in the target range (3.9-10 mmol/L) was increased during closed-loop insulin delivery compared with sensor-augmented pump therapy (72 vs. 53%, P < 0.001; primary end point), the mean glucose concentration was lowered (8.7 vs. 10.1 mmol/L, P = 0.028), and the time spent above the target level was reduced (P = 0.005) without changing the total daily insulin amount (P = 0.55). The time spent in the hypoglycemic range was low and comparable between interventions.
conclusionsUnsupervised day-and-night hybrid closed-loop insulin delivery at home is feasible and safe in young people with type 1 diabetes. Compared with sensor-augmented insulin pump therapy, closed-loop insulin delivery may improve glucose control without increasing the risk of hypoglycemia in adolescents with suboptimally controlled type 1 diabetes.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.