Presenter of 2 Presentations
MEAL ANTICIPATION MAY IMPROVE FULL CLOSED LOOP CONTROL IN ADULTS WITH TYPE 1 DIABETES
Abstract
Background and Aims
Hybrid closed-loop (HCL) automated insulin delivery (AID) systems improve glycemic control in people with type 1 diabetes (T1D) but remain largely dependent on announcement and quantification of meals. Full closed loop (FCL) offers to remove this dependency but needs to be clinically validated.
Methods
In a randomized crossover supervised clinical trial of T1D adults, we assess the feasibility of three AID modalities: HCL, FCL, and FCL with anticipation of personalized meal patterns (FCL+). After a 4-week data collection, each modality was tested in random order during three identical 24h periods with standardized meals of different timing: dinner was 90-120min later than usual (per data collection); breakfast occurred as expected; lunch fixed at 1pm. We present an interim analysis (without comparative statistical analysis) of CGM-based outcomes (mean±sd or median[quartiles] as appropriate) overall, 2h-pre-meals, and 5h-post-meal.
Results
18 adult participants with T1D completed the protocol to date (N=36 expected at trial end). No serious adverse events were reported. Overall time in range (TIR) was excellent in all modalities (HCL: 86.3±8.2, FCL: 76.9±13.0%, FCL+: 78.1±12.1%), with low time below range (TBR, HCL: 0.7[0-2.8]%, FCL: 0[0-3.8]%, FCL+: 0.8[0-2.1]%). The nominal meal control (breakfast) showed HCL dominating FCL, with FCL+ in between: TIR=77.6±24.4%, 58.5±25.0%, and 66.3±23.6% respectively; increased insulin delivery pre-breakfast was observed for FCL+ (figure). Delaying meals showed no clear trend towards hypoglycemia, TBR, HCL:0[0-12.5]%, FCL:0[0-0]%, FCL+:0[0-8.3]%.
Conclusions
All modalities provided adequate glycemic control overall in this very controlled environment; meal anticipation appears to be safe and may mitigate some lost post-prandial control.
AUTOMATED INSULIN DELIVERY (AID)-ENHANCED WITH SGLT2I AS COMBINED THERAPY IN TYPE 1 DIABETES
Abstract
Background and Aims
Use of sodium-glucose cotransporter 2 inhibitors (SGLT2i) as adjunct therapy to insulin in type 1 diabetes (T1D) has been previously studied. Here we present data from the first free-living trial combining low-dose SGLT2i with commercial automated insulin delivery (AID) or predictive low glucose suspend (PLGS) systems.
Methods
In an eight-week, randomized, controlled, crossover trial, adults with T1D received 5 mg/day empagliflozin (EMPA) or no drug (NOEMPA) as adjunct to insulin therapy. Participants were also randomized to sequential orders of AID (Control-IQ) and PLGS (Basal-IQ) systems for four and two weeks, respectively. The primary endpoint was percent time-in-range (TIR) 3·9-10mmol/L during daytime (7:00-23:00h) while on AID (NCT04201496).
Results
39 subjects were enrolled, 35 were randomized, 34 (EMPA; n=18 and NOEMPA n=16) were analyzed with intention-to-treat intention (IIT), 32 (EMPA; n=16 and NOEMPA n=16) completed the trial. On AID, EMPA vs. NOEMPA had higher daytime TIR 81% vs. 71% with a mean estimated difference of +9·9% [95%CI 0.6 to 19.1];p=0.04. On PLGS, the EMPA vs NOEMPA daytime TIR was 80% vs. 63%, mean estimated difference of +16.5%[95% CI 7.3, 25.7];p<0.001. One subject on SGLT2i and AID had mild diabetic ketoacidosis that was precipitated by non-functioning insulin pump infusion site blockage.
Conclusions
In an eight-week outpatient study, the addition of 5 mg daily empagliflozin to commercially available AID or PLGS systems significantly improved daytime glucose control in individuals with T1D, without increased hypoglycemia risk. These promising results warrant further evaluation in large-scale clinical trials.