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Dexcom presenterar den första och enda kontrollerade studien med slumpmässigt urval som enbart fokuserar på nyttan av kontinuerlig glukosmätning (CGM) för diabetespatienter som behandlas med flera dagliga injektioner (MDI).
 
Diamondstudien (som på engelska står för Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes) är den första i sitt slag som visar effekterna av CGM på A1C och hypoglykemi i ett program där deltagarna fått multipla dagliga injektioner av insulin.
 
Studien, som publicerades den 24 januari i Journal of the American Medical Association (JAMA), visar att användare av Dexcoms CGM-system med flera dagliga injektioner uppnådde en minskning av A1C på i genomsnitt en procent efter 24 veckors regelbunden användning, jämfört med utgångsläget.
 
Förutom bättre glukoskontroll kunde deltagarna även öka tiden med önskade glukosvärden och minska tiden med hypoglykemi och hyperglykemi när de använde Dexcoms CGM-system jämfört med dem som endast använde en standardmätare för att övervaka sina glukosvärden.
 
– I diabetesvärlden är det en vanlig uppfattning att de som använder insulinpump passar bättre för användning av CGM, och att patienter som ingår i ett MDI-program inte skulle gynnas av detta, antingen för att de inte skulle vara villiga att bära en CGM-enhet eller för de inte skulle använda informationen för att göra de förändringar som krävs för bättre blodsockerkontroll. Diamondstudien gör betydande framsteg i att bevisa att ett brett spektrum av diabetespatienter som tar insulininjektioner kan dra nytta av CGM-systemet, säger Roy Beck, MD, Jaeb, Center for Health Research i Tampa, Florida.
 
I Diamondstudien ingick 158 vuxna deltagare med typ 1-diabetes med MDI (Multiple Daily Injections). Vid 24 veckor var den genomsnittliga A1C-reduktionen (ett mått på genomsnittlig blodglukos under en 2-3 månaders period) hos patienter i CGM-gruppen (n = 105) en procent eller 10 mmol/mol jämfört med utgångsläget. Försökspersoner i kontrollgruppen SMBG visade endast en minskning på 0,4 procent  eller 4 mmol/mol (n = 53); (P < 0,001). CGM-systemet som används i studien var Dexcom G4® PLATINUM CGM Företaget Dexcom G5® Mobile CGM System, använder också denna programvara.
 
En undergrupp av patienter som ansågs vara okontrollerade med A1C på mer än 8,5 procent, kunde notera en minskning på 1,3 procent eller 13 mmol/mol av A1C från utgångsläget vid vecka 24.
 
Diamondstudien som presenterades vid det 76:e årsmötet för American Diabetes Association i juni 2016 spårade även tiden patienterna tillbringade i hypoglykemi och fann en signifikant minskning i CGM-gruppen jämfört med utgångsläget:
 
* 49 procent minskning av tiden < 70mg/dL(3.9 mmol/L)
* 53 procent minskning av tiden < 60 mg/dL(3.3 mmol/L)
* 69 procent minskning av tiden < 50mg/dL (2.8 mmol/L)
 
CGM-användare visade en signifikant minskning av hypoglykemi under natten då de spenderar endast 0,6 procent av tiden i hypoglykemi jämfört med 2,9 procent vid utgångsläget.
 
Studien fann också att CGM-patienter spenderade betydligt kortare tid (58 minuter) i hyperglykemi ( > 300 mg/dL eller 16,6 mmol/L) jämfört med utgångsvärdet och visade en kraftig ökning av tid i närheten av det önskade värdet (70-180mg/dL eller 3,9-10,0 mmol/L) på 1,3 timmar.
 
Dessutom avfärdar studien uppfattningen att CGM-systemet är alltför komplicerat att använda, eftersom patienterna visade betydande minskningar av A1C oavsett utbildningsnivå, matematisk förmåga eller ålder. Väldigt många följde också rekommendationerna, hela 93 procent av patienterna använder fortfarande Dexcoms CGM-system ≥6 dagar i veckan, i slutet av studien.
 
– En förbättrad noggrannhet och tillförlitlighet i CGM-tekniken har giort att patienterna fått förtroende för utrustningen och betraktar dem som viktiga verktyg för att övervaka sitt blodsocker, säger Kevin Sayer, VD, Dexcom. Vi är mycket glada över att Dexcoms CGM-system kunde visa betydande fördelar bland olika grupper av patienter, men ännu viktigare är att de positiva resultaten bland befolkningen som är 60+ kommer att vara avgörande för våra ansträngningar i USA att driva CGM-användningen för US Medicare-berättigade patienter.
 
Press release
 
Utdrag från artikeln
JAMA 

Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections
The DIAMOND Randomized Clinical Trial
 
Roy W. Beck, MD, PhD; Tonya Riddlesworth, PhD; Katrina Ruedy, MSPH; Andrew Ahmann, MD; Richard Bergenstal, MD; Stacie Haller, RD, LD, CDE; Craig Kollman, PhD; Davida Kruger, MSN, APN-BC; Janet B. McGill, MD; William Polonsk
 
Abstract
IMPORTANCE Previous clinical trials showing the benefit of continuous glucose monitoring (CGM) in the management of type 1 diabetes predominantly have included adults using insulin pumps, even though the majority of adults with type 1 diabetes administer insulin by injection.
 
OBJECTIVE TodeterminetheeffectivenessofCGMinadultswithtype1diabetestreatedwith insulin injections.
 
DESIGN,SETTING,ANDPARTICIPANTS RandomizedclinicaltrialconductedbetweenOctober 2014 and May 2016 at 24 endocrinology practices in the United States that included 158 adults with type 1 diabetes who were using multiple daily insulin injections and had hemoglobin A1c (HbA1c) levels of 7.5% to 9.9%.
 
INTERVENTIONS Randomassignment2:1toCGM(n=105)orusualcare(controlgroup;n=53).
 
MAINOUTCOMESANDMEASURES Primaryoutcomemeasurewasthedifferenceinchange in central-laboratory–measured HbA1c level from baseline to 24 weeks. There were 18 secondary or exploratory end points, of which 15 are reported in this article, including duration of hypoglycemia at less than 70 mg/dL, measured with CGM for 7 days at 12
and 24 weeks.
 
RESULTS Amongthe158randomizedparticipants(meanage,48years[SD,13];44%women; mean baseline HbA1c level, 8.6% [SD, 0.6%]; and median diabetes duration, 19 years [interquartile range, 10-31 years]), 155 (98%) completed the study. In the CGM group, 93% used CGM 6 d/wk or more in month 6. Mean HbA1c reduction from baseline was 1.1% at 12 weeks and 1.0% at 24 weeks in the CGM group and 0.5% and 0.4%, respectively, in the control group (repeated-measures model P < .001). At 24 weeks, the adjusted treatment-group difference in mean change in HbA1c level from baseline was –0.6% (95% CI, –0.8% to –0.3%; P < .001). Median duration of hypoglycemia at less than <70 mg/dL was
43 min/d (IQR, 27-69) in the CGM group vs 80 min/d (IQR, 36-111) in the control group (P = .002). Severe hypoglycemia events occurred in 2 participants in each group.
 
CONCLUSIONSANDRELEVANCE Amongadultswithtype1diabeteswhousedmultipledaily insulin injections, the use of CGM compared with usual care resulted in a greater decrease in HbA1c level during 24 weeks. Further research is needed to assess longer-term effectiveness, as well as clinical outcomes and adverse effects.
 
TRIALREGISTRATION clinicaltrials.govIdentifier:NCT02282397
 
Key Points
Question Foradultswithtype1diabeteswhoareusingmultiple daily insulin injections, does continuous glucose monitoring improve hemoglobin A1c (HbA1c) levels compared with self-monitored blood glucose management?
 
Findings In a randomizedclinicaltrialof158adultswithtype1 diabetes, there was a significantly greater decrease in HbA1c level during 24 weeks with continuous glucose monitoring vs usual care (–1.0% vs –0.4%).
 
Meaning Continuousglucosemonitoringresultedinbetter glycemic control compared with usual care, but further research is needed to assess clinical outcomes, as well as effectiveness, in a typical clinical population.
1c 1c

INTRODUCTION
Only approximately 30% of individuals with type 1 diabetes meet the American Diabetes Association goal of hemoglobin A (HbA ) level of 7.5% (58 mmol/mol)for children (<18 years) and 7.0% (53 mmol/mol) for adults (≥18 years),1 indicating the need for better approaches to diabetes management. Continuous glucose monitoring (CGM) with glucose measurements as often as every 5 minutes, plus low and high glucose level alerts and glucose trend informa- tion, has the capability of better informing diabetes manage- ment decisions than blood glucose meter testing performed several times a day. Randomized clinical trials have demon- strated the benefit of CGM in adults with type 1 diabetes, but not consistently in children, to improve glycemic control as measured by HbA1c level and to reduce hypoglycemia.2-6 These previous trials have either completely or predominantly in- cluded insulin pump users,2,4,5 although the majority of adults with type 1 diabetes deliver insulin via injections.7,8
 
Only a small proportion of individuals with type 1 diabetes who inject insulin use CGM, although the limited avail- able observational data suggest that the glycemic benefit may be comparable to that for pump users. In T1D Exchange reg- istry 2015 data, mean HbA1c level in the 410 adult insulin in- jecters using CGM was similar to that in 2316 pump users using CGM (7.6% vs 7.7%, respectively) and lower than mean HbA1c level in the 6222 injection users not using CGM (7.6% vs 8.8%; P < .001).9
 
Whether individuals receiving insulin injections would be willing to regularly wear CGM sensors and would derive glyce- mic benefits from CGM needs investigation. Accordingly, this ran- domized multicenter clinical trial was conducted to evaluate the effect of CGM in adults with type 1 diabetes who have elevated HbA1c levels and use multiple daily injections of insulin.
 
Discussion
Among adults with type 1 diabetes using multiple daily insu- lin injections, the use of CGM compared with usual care resulted in a greater decrease in HbA1c level during 24 weeks. The HbA1c benefit in the CGM group was consistently present across the age range of 26 to 73 years, the baseline HbA1c level range of 7.5% to 9.9%, and all education levels. In addition, CGM use was associated with a high degree of participant satisfaction with CGM, increased time with glu- cose concentrations between 70 and 180 mg/dL, decreased time with glucose concentrations less than 70 mg/dL, and decreased glycemic variability, measured with the coefficientof variation. The trial was not designed to demonstrate a ben- efit in reducing clinical severe hypoglycemia events, and the low event rate in the control group precluded a meaningful analysis. However, less biochemical hypoglycemia, as was observed in the trial, has been associated with a lower risk for subsequent severe hypoglycemic events14,15 and improved quality of life.16-18
 
The amount of CGM use by the participants was high (median CGM use 7 d/wk in month 6) despite a protocol ap- proximating usual practice, with only 1 visit after week 4 and no visits or other protocol-specified contacts between 12 and 24 weeks. The amount of use was similar to or greater than the frequency of use in pump-using adults with type 1 diabetes in previous trials and observational studies,2-5,19 which could be related to CGM accuracy being significantly improved from the generation of sensors in previous trials.20-22 The observed ben- efits of CGM occurred despite the CGM group’s having signifi- cantly less blood glucose meter testing per day than the con- trol group.
 
The magnitude of benefit of CGM on HbA1c levels relative to control in this trial of insulin injection users is com- parable to the magnitude of benefit of CGM observed in pump users in previous randomized trials.2,4,5 This finding was not a foregone conclusion. Insulin injection users have less flexibility in adjusting their insulin delivery in response to CGM glucose concentrations and trends than do pump users. Basal insulin delivery for pump users is continuous, can be programmed to vary at different times of the day, and can be temporarily changed in response to decreasing or increasing glucose concentrations or planned activities such as exercise. In contrast, injection users have fixed basal insulin based on the absorption of their long-acting insulin and can make adjustments only to rapid-acting insulin boluses.
 
The strengths of the trial included a high retention rate, high adherence to treatment group assignment, central labo- ratory measurement of HbA1c level, a protocol approximating usual clinical practice, and participation in the trial by both community-based and academic sites. Assignment to the CGM and control groups could not be blinded because of the na- ture of the intervention; however, the groups had a similar number of visits. The 0.4% mean improvement in HbA1c level in the control group likely reflects both a study effect related to clinical trial participation and more structured training in using blood glucose monitoring in adjusting insulin regimens than was occurring for these individuals before the study.
 
This study also had several limitations. In light of the eligibility criteria, the results may not apply to individuals with type 1 diabetes who are younger than 26 years or have HbA1c levels outside the range of 7.5% to 9.9% and should not be applied to individuals with type 2 diabetes who receive multiple daily injections of insulin. The informed consent process and the run-in phase had the potential to exclude individuals who might be less adherent with CGM than the cohort that was studied.
 
Conclusions
Among adults with type 1 diabetes who use multiple daily in- sulin injections, the use of CGM compared with usual care re- sulted in a greater decrease in HbA1c level during 24 weeks. Further research is needed to assess longer-term effective
 
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