Trial reportJournal of diabetes science and technology2017
Manual Closed-Loop Insulin Delivery Using a Saddle Point Model Predictive Control Algorithm: Results of a Crossover Randomized Overnight Study.
Trial report in Journal of diabetes science and technology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02061488 (Prospective, Monocentric, Crossover Randomized Trial, to Assess a New Closed-loop Algorithm in Type 1 Diabetes), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.
What it found
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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.
Prospective, Monocentric, Crossover Randomized Trial, to Assess a New Closed-loop Algorithm in Type 1 Diabetes (Saddle Point Model Predictive Control : SP-MPC)
Who cites it
1 citing paper in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.
- Efficacy and safety of closed-loop insulin delivery versus sensor-augmented pump in the treatment of adults with type 1 diabetes: a systematic review and meta-analysis of randomized-controlled trials.Journal of endocrinological investigation · 2022Pooled it
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe purpose was to assess the efficacy of a new closed-loop algorithm (Saddle Point Model Predictive Control, SP-MPC) in achieving nocturnal normoglycemia while reducing the risk of hypoglycemia in patients with type 1 diabetes.
methodIn this randomized crossover study, 10 adult patients (mean hemoglobin A1c 7.35 ± 1.04%) were assigned to be treated overnight by open loop using sensor-augmented pump therapy (open-loop SAP) or manual closed-loop delivery. During closed loop, insulin doses were calculated using the SP-MPC algorithm and administered as manual boluses every 15 minutes from 9:00 pm to 8:00 am. Patients consumed a self-selected meal (65-125 g of carbohydrates) at 7:00 pm accompanied by their usual prandial bolus. Blood glucose was measured every 30 minutes. The primary endpoints were the time spent in target (70-145 mg/dl) and time spent below 70 mg/dl from 11:00 pm to 8:00 am.
resultsTime spent in target did not differ between closed-loop and open-loop SAP. The number of hypoglycemic events (<70 mg/dl) was reduced 2.8-fold in closed loop (n = 5, median = 0/patient/hour; interquartile range: 0-0.11) as compared to open-loop SAP (n = 14, median = 0.22/patient/hour, 0.02-0.22) ( P = .02). The area under the curve for sensor glucose values >145 mg/dl was significantly lower during closed-loop than during open-loop SAP ( P = .03) as well as HBGI ( P = .02).
conclusionsThis pilot study suggests that the use of the SP-MPC algorithm may improve mean overnight glucose control and reduce the number of hypoglycemic events as compared to SAP therapy.
Indexed as
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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.