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Majority of persons with type 1 diabetes on multiple daily insulin injections benefit from continuous glucose monitoring. Oral presentation på EASD

Arndís F. Ólafsdóttir, Jan Bolinder, Tim Heise, William Polonsky, Magnus Ekelund, Magnus Wijkman, Aldina Pivodic, Erik, Schwarcz, Thomas Nyström, Jarl Hellman, Irl B. Hirsch, Marcus Lind

Möjligheterna för CGM för personer med typ 1 diabetes ser väldigt olika ut i världen med olika riktlinjer i varje land. 

Målet med denna studie var att identifiera de som får HbA1c förbättring och de som förbättrar sin tid i hypoglykemi när vi jämför kapillära blodsockermätningar med CGM behandling. Vi även identifierade vilka baseline variable var associerade med dessa förbättringar. 

Dessa analyser är baserade på data från GOLD studien, en multi-center randomiserad cross-over studie som gjordes i Sverige och publicerades 2017.

Då det visade sig att deltagaren både sänkte sitt HbA1c och förbättrade sin tid i hypoglykemi när vi jämförde CGM mot kapillära mätningar ville vi se om det fanns en association mellan dessa variabler. Vi gjorde en korrelations analys som visade en tydlig negativ korrelation mellan dessa två förbättrade variabler med p värde av <0,0001 både för hypoklykemi under 3,9 mmol/l och 3,0 mmol/l.  Med andra ord de som sänker sitt HbA1c mer har mindre förbättring av sin tid i hypoglykemi och tvärtom.

Vi hittade att 47% av deltagarna förbättrade sitt HbA1c med mer än 4mmol/mol och 47% sänkte sin tid i hypoglykemi med mer än 20 minuter.  

• 78% hade sänkt sitt HbA1c eller sänkt sin tid i hypoglykemi men enbart                                                                             • 14% hade sänkt både sin tid i hypoglykemi med mer än 20 minuter och sitt                                                                • HbA1c med mer än 4 mmol/mol när vi jämförde kapillära blodglukosmätningar med CGM.

Det var 38% som sänkte sin tid i hypoglykemi > 30 minuter, 75% som både sänkte sin tid i hypoglykemi och sitt HbA1c >4mmol/mol och enbart 9% som förbättrade båda dessa variabler. 

Baseline variabler associerade med sänkning av HbA1c var högre baseline HbA1c, lägre tid i hypoglykemi och högre tid med hyperglykemi. 

Ökad tid med glukosvärden under 3,0 mmol/l vid baseline och mer positiva resultat på hypoglycaemic confidence scale var även prediktiva för förbättring av tid i hypoglykemi. Kvinnor hade mer sänkning av tid i hypoglykemi än män.

Vi hittade ingen association mellan antal kapillära mätningar innan studie start och sänkt HbA1c eller minskad tid i hypoglykemi. 

Autoreferat

skickat till DiabetologNytt av Arndís F. Ólafsdóttir

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www red DiabetologNytt

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Läs mer i abstract

https://care.diabetesjournals.org/content/early/2019/09/10/dc19-0888

Jan Šoupal med flera

Abstract

OBJECTIVE This study assessed the clinical impact of four treatment strategies in adults with type 1 diabetes (T1D): real-time continuous glucose monitoring (rtCGM) with multiple daily insulin injections (rtCGM+MDI), rtCGM with continuous subcutaneous insulin infusion (rtCGM+CSII), self-monitoring of blood glucose with MDI (SMBG+MDI), and SMBG with CSII (SMBG+CSII).

RESEARCH DESIGN AND METHODS This 3-year, nonrandomized, prospective, real-world, clinical trial followed 94 participants with T1D (rtCGM+MDI, n = 22; rtCGM+CSII, n = 26; SMBG+MDI, n = 21; SMBG+CSII, n= 25). The main end points were changes in A1C, time in range (70–180 mg/dL [3.9–10 mmol/L]), time below range (<70 mg/dL [<3.9 mmol/L]), glycemic variability, and incidence of hypoglycemia.

RESULTS At 3 years, the rtCGM groups (rtCGM+MDI and rtCGM+CSII) had significantly lower A1C (7.0% [53 mmol/mol], P = 0.0002, and 6.9% [52 mmol/mol], P < 0.0001, respectively), compared with the SMBG+CSII and SMBG+MDI groups (7.7% [61 mmol/mol], P = 0.1.000, and 8.0% [64 mmol/mol], P = 0.3574, respectively), with no significant difference between the rtCGM groups. Significant improvements in percentage of time in range were observed only in the rtCGM subgroups (rtCGM+MDI, 48.7–69.0%, P < 0.0001; and rtCGM+CSII, 50.9–72.3%, P < 0.0001) and significant reductions in time below range (9.4–5.5%, P = 0.0287; and 9.0–5.3%, P = 0.0325, respectively). Seven severe hypoglycemia episodes occurred: SMBG groups, n = 5; sensor-augmented insulin regimens (SAIR) groups, n = 2.

CONCLUSIONS rtCGM was superior to SMBG in reducing A1C, hypoglycemia, and other end points in individuals with T1D regardless of their insulin delivery method. rtCGM+MDI can be considered an equivalent but lower-cost alternative to sensor-augmented insulin pump therapy and superior to treatment with SMBG+MDI or SMBG+CSII therapy.

 

Arndís Ólafsdóttir med flera.

https://www.abstractsonline.com/pp8/#!/7895/presentation/1217

AbstractBackground and aims: As there is little evidence as to which patient groups have greatest benefits of using continuous glucose monitoring (CGM), only a select few have the possibility to use CGM to help manage their glucose in daily life. We evaluated to what extent patients improve their HbA1c and reduce time in hypoglycaemia by CGM use.
Materials and methods: The analyses are based on the GOLD study,a cross-over, multi-centre randomised clinical trial. Adults with type 1 diabetes (T1D), treated with Multiple Daily Insulin Injections (MDI), HbA1c > 58 mmol/mol, were randomised to use CGM or Self Measurement of Blood Glucose (SMBG) for 26 weeks and then switch treatments after 17 weeks washout period. Difference between treatment periods was measured.
Results: We found a negative correlation between those who experienced improved HbA1c and reduction of time in hypoglycaemia <4.0 mmol/l, R = -0.52 (p< .0001), <3.0 mmol/l R= -0.38 (p<.0001).46.5% of participants had a reduction ≥4.4 mmol/mol (0.4%) in HbA1c during CGM use compared to SMBG and 47.2% decreased their time in hypoglycaemia by ≥20 min. (1.4%)/ 24 hrs. 78.1% of all participants either improved their HbA1c by ≥4.4 mmol/mol (0.4%) or their time in hypoglycaemia by ≥20 min./ 24 hours. 13.8% of participants experienced both benefits (see figure). 38.2% decreased their time in hypoglycemia by ≥ 30 min. (2.0%)/24 hrs, 74.5% decreased their HbA1c or time in hypoglycemia ≥ 30 min. and 8.9% decreased both HbA1c and time in hypoglycaemia for more than 30 min./ 24 hrs.
Conclusion: The absolute majority of persons with T1D experience benefits by using CGM but some experience a reduction in HbA1c whilst others reduce their time in hypoglycaemia. Few patients have effects on both variables. Care-givers, decision-makers for reimbursement and diabetes guidelines need to consider that the absolute majority of patients receive a benefit of CGM and that there are no clear responders and non-responders.

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