Kontinuerlig blodsockermätning är positivt för högriskpatienter för hypoglykemi, skriver www.dagensmedicin.se Petra Hedbom, och fortsätter som nedtill.
I studien ville forskarna ta reda på om personer med typ 1-diabetes och som har problem med hypoglykemi, alltså att blodsockernivån blir för låg, kan få bättre kontroll med så kallade CGM-system. Med ett sådant system mäts blodsockret kontinuerligt flera hundra gånger per dygn via en sensor som fästs på huden.
I studien ingick 149 personer med diabetes typ-1 som behandlades med insulin flera gånger dagligen. Samtliga hade haft svårigheter att hålla sina blodsockernivåer stabila under en längre tid och hade haft minst en episod av svår hypoglykemi det senaste året.
I tidigare studier där nyttan med kontinuerlig blodsockermätning studerats, har man enligt artikelförfattarna inte inkluderat personer med återkommande hypoglykemier.
De första fyra veckorna använde samtliga deltagare ett CGM-system. Data om blodsockernivåer samlades in centralt och utgjorde en ursprungsnivå. Därefter slumpades hälften av deltagarna till att fortsätta mäta med hjälp av ett CGM-system under 26 veckor. Den andra hälften utgjorde kontrollgrupp och övergick till egenmonitorering av blodsockret under samma tidsperiod.
Det primära utfallsmåttet var antal episoder av hypoglykemi under de sista 26 veckorna jämfört med ursprungsnivån. Hypoglykemi definierades som 3,0 mmol/l eller lägre under minst 20 minuter.
Resultatet visade att personerna som mätte blodsockret med CGM-system minskade antalet episoder från 10,8 till 3,5 motsvarande 72 procent. Personerna i kontrollgruppen gick från 14,4 till 13,7 episoder, vilket enligt författarna är försumbart. Dessutom hade personerna i CGM-gruppen jämnare blodsockernivåer än de i kontrollgruppen.
Detta, skriver de, gör att resultaten tillför viktig kunskap om att den här gruppen diabetiker kan ha stor nytta av CGM-system.
Läs abstract till studien:
Lutz Heinemann med flera. Real-time continuous glucose monitoring in adults with type 1 diabetes and impaired hypoglycaemia awareness or severe hypoglycaemia treated with multiple daily insulin injections (HypoDE): a multicentre, randomised controlled trial, Lancet, publicerad online 16 februari 2018.https://doi.org/10.1016/S0140-6736(18)30297-6
Lutz Heinemann med flera. Real-time continuous glucose monitoring in adults with type 1 diabetes and impaired hypoglycaemia awareness or severe hypoglycaemia treated with multiple daily insulin injections (HypoDE): a multicentre, randomised controlled trial, Lancet, publicerad online 16 februari 2018.https://doi.org/10.1016/S0140-6736(18)30297-6
Real-time continuous glucose monitoring in adults with type 1 diabetes and impaired hypoglycaemia awareness or severe hypoglycaemia treated with multiple daily insulin injections (HypoDE): a multicentre, randomised controlled trial
Prof Lutz Heinemann, PhD, Guido Freckmann, MD, Dominic Ehrmann, PhD, Gabriele Faber-Heinemann, MA, Stefania Guerra, PhD, Delia Waldenmaier, MSc, Prof Norbert Hermanns,
Published: 16 February 2018
The effectiveness of real-time continuous glucose monitoring (rtCGM) in avoidance of hypoglycaemia among high-risk individuals with type 1 diabetes treated with multiple daily insulin injections (MDI) is unknown. We aimed to ascertain whether the incidence and severity of hypoglycaemia can be reduced through use of rtCGM in these individuals
Methods
The HypoDE study was a 6-month, multicentre, open-label, parallel, randomised controlled trial done at 12 diabetes practices in Germany. Eligible participants had type 1 diabetes and a history of impaired hypoglycaemia awareness or severe hypoglycaemia during the previous year. All participants wore a masked rtCGM system for 28 days and were then randomly assigned to 26 weeks of unmasked rtCGM (Dexcom G5 Mobile system) or to the control group (continuing with self-monitoring of blood glucose). Block randomisation with 1:1 allocation was done centrally, with the study site as the stratifying variable. Masking of participants and study sites was not possible. Control participants wore a masked rtCGM system during the follow-up phase (weeks 22–26). The primary outcome was the baseline-adjusted number of hypoglycaemic events (defined as glucose ≤3·0 mmol/L for ≥20 min) during the follow-up phase. The full dataset analysis comprised participants who wore the rtCGM system during the baseline and follow-up phases. The intention-to-treat analysis comprised all randomised participants. This trial is registered with ClinicalTrials.gov, number NCT02671968.
Findings
Between March 4, 2016, and Jan 12, 2017, 149 participants were randomly assigned (n=74 to the control group; n=75 to the rtCGM group) and 141 completed the follow-up phase (n=66 in the control group, n=75 in the rtCGM group). The mean number of hypoglycaemic events per 28 days among participants in the rtCGM group was reduced from 10·8 (SD 10·0) to 3·5 (4·7); reductions among control participants were negligible (from 14·4 [12·4] to 13·7 [11·6]). Incidence of hypoglycaemic events decreased by 72% for participants in the rtCGM group (incidence rate ratio 0·28 [95% CI 0·20–0·39], p<0·0001). 18 serious adverse events were reported: seven in the control group, ten in the rtCGM group, and one before randomisation. No event was considered to be related to the investigational device.
Interpretation
Usage of rtCGM reduced the number of hypoglycaemic events in individuals with type 1 diabetes treated by MDI and with impaired hypoglycaemia awareness or severe hypoglycaemia.
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