Abstract

BACKGROUND

Closed-loop systems that automate insulin delivery may improve glycemic outcomes in patients with type 1 diabetes.

METHODS

In this 6-month randomized, multicenter trial, patients with type 1 diabetes were assigned in a 2:1 ratio to receive treatment with a closed-loop system (closed-loop group) or a sensor-augmented pump (control group). The primary outcome was the percentage of time that the blood glucose level was within the target range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter), as measured by continuous glucose monitoring.

RESULTS

A total of 168 patients underwent randomization; 112 were assigned to the closed-loop group, and 56 were assigned to the control group. The age range of the patients was 14 to 71 years, and the glycated hemoglobin level ranged from 5.4 to 10.6%. All 168 patients completed the trial. The mean (±SD) percentage of time that the glucose level was within the target range increased in the closed-loop group from 61±17% at baseline to 71±12% during the 6 months and remained unchanged at 59±14% in the control group (mean adjusted difference, 11 percentage points; 95% confidence interval [CI], 9 to 14; P<0.001). The results with regard to the main secondary outcomes (percentage of time that the glucose level was >180 mg per deciliter, mean glucose level, glycated hemoglobin level, and percentage of time that the glucose level was <70 mg per deciliter or <54 mg per deciliter [3.0 mmol per liter]) all met the prespecified hierarchical criterion for significance, favoring the closed-loop system. The mean difference (closed loop minus control) in the percentage of time that the blood glucose level was lower than 70 mg per deciliter was −0.88 percentage points (95% CI, −1.19 to −0.57; P<0.001). The mean adjusted difference in glycated hemoglobin level after 6 months was −0.33 percentage points (95% CI, −0.53 to −0.13; P=0.001). In the closed-loop group, the median percentage of time that the system was in closed-loop mode was 90% over 6 months. No serious hypoglycemic events occurred in either group; one episode of diabetic ketoacidosis occurred in the closed-loop group.

CONCLUSIONS

In this 6-month trial involving patients with type 1 diabetes, the use of a closed-loop system was associated with a greater percentage of time spent in a target glycemic range than the use of a sensor-augmented insulin pump. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases; iDCL ClinicalTrials.gov number, NCT03563313. opens in new tab.)

https://www.nejm.org/doi/full/10.1056/NEJMoa1907863

SAMMANFATTNING

Detta är den längsta studien med T1DM med closed loop, självstyrande pump, och som är randomiserad. Den omfattar både ungdomar och vuxna. Patienter med pump skötte pumpen i samband med födointag med bolus med kolhydraträkning och värdet lades in i pumpen av patienten. 

Time in Range TIR dagtid ökade dramatiskt med pump med 9%, från 61 till 71%, och nattetid, den kanske viktigaste del av dygnet, med 16%, från 59-76%.

HbA1c förbättrades med 0,33 mmol/mol och utan att öka risken för hypoglykemi..Var 5:e dag behövde individerna med pump ta ett blodsocker. CGM-delen var självkalibrerande. Nöjdhetsgraden låg i topp med 4,8 med max 5,0.

Sålunda ett stort forskningsframsteg för closed loop pump avseende effektivitet och också säkerhet med denna pump Tandem Control IQ. Tidigare finns endast en annan självstyrande pump, Medtronic 670G. 

Nyhetsinfo

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