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Randomized Controlled Trial
. 2023 Sep 1;46(9):1652-1658.
doi: 10.2337/dc23-0119.

Assessment of Meal Anticipation for Improving Fully Automated Insulin Delivery in Adults With Type 1 Diabetes

Jose Garcia-Tirado  1   2 , Patricio Colmegna  1 , Orianne Villard  1   3 , Jenny L Diaz  1 , Rebeca Esquivel-Zuniga  4 , Chaitanya L K Koravi  1 , Charlotte L Barnett  1 , Mary C Oliveri  1 , Morgan Fuller  1 , Sue A Brown  1   5 , Mark D DeBoer  1   4 , Marc D Breton  1
Affiliations
Randomized Controlled Trial

Assessment of Meal Anticipation for Improving Fully Automated Insulin Delivery in Adults With Type 1 Diabetes

Jose Garcia-Tirado et al. Diabetes Care. .

Abstract

Objective: Meals are a consistent challenge to glycemic control in type 1 diabetes (T1D). Our objective was to assess the glycemic impact of meal anticipation within a fully automated insulin delivery (AID) system among adults with T1D.

Research design and methods: We report the results of a randomized crossover clinical trial comparing three modalities of AID systems: hybrid closed loop (HCL), full closed loop (FCL), and full closed loop with meal anticipation (FCL+). Modalities were tested during three supervised 24-h admissions, where breakfast, lunch, and dinner were consumed per participant's home schedule, at a fixed time, and with a 1.5-h delay, respectively. Primary outcome was the percent time in range 70-180 mg/dL (TIR) during the breakfast postprandial period for FCL+ versus FCL.

Results: Thirty-five adults with T1D (age 44.5 ± 15.4 years; HbA1c 6.7 ± 0.9%; n = 23 women and n = 12 men) were randomly assigned. TIR for the 5-h period after breakfast was 75 ± 23%, 58 ± 21%, and 63 ± 19% for HCL, FCL, and FCL+, respectively, with no significant difference between FCL+ and FCL. For the 2 h before dinner, time below range (TBR) was similar for FCL and FCL+. For the 5-h period after dinner, TIR was similar for FCL+ and FCL (71 ± 34% vs. 72 ± 29%; P = 1.0), whereas TBR was reduced in FCL+ (median 0% [0-0%] vs. 0% [0-0.8%]; P = 0.03). Overall, 24-h control for HCL, FCL, and FCL+ was 86 ± 10%, 77 ± 11%, and 77 ± 12%, respectively.

Conclusions: Although postprandial control remained optimal with hybrid AID, both fully AID solutions offered overall TIR >70% with similar or lower exposure to hypoglycemia. Anticipation did not significantly improve postprandial control in AID systems but also did not increase hypoglycemic risk when meals were delayed.

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Conflict of interest statement

Duality of Interest. J.G.-T. and P.C. report receiving industry research support and royalties from Dexcom, Inc. M.D.D. reports receiving grant or material support from Tandem Diabetes Care, Medtronic, and Dexcom, Inc. M.D.B. has received honoraria and travel reimbursement from Dexcom, Inc., and Tandem Diabetes Care and research support from Dexcom, Inc., Novo Nordisk, and Tandem Diabetes Care. No other potential conflicts of interest relevant to this article were reported.

Figures

None
Graphical abstract
Figure 1
Figure 1
Percent time <70 (TBR70), TIR, time >180 (TAR180), and time >250 mg/dL (TAR250) for different time windows: overall, daytime (7:00 a.m.–11:00 p.m.), overnight (11:00 p.m.–7:00 a.m.), breakfast 5-h postprandial (PP), dinner 2-h preprandial, and dinner 5-h PP.
Figure 2
Figure 2
Glucose levels over time by AID system, FCL+ (blue) and FCL (gray), for the time window from 2 h before breakfast to 3 h after breakfast. A: Percent time <70 (TBR70), TIR, time >180 (TAR180), and time >250 mg/dL (TAR250). B: CGM and IOB data shown centered over the meal. Black vertical dotted line represents commencement of the meal. Solid blue and black lines and shaded areas represent mean glucose and 25th–75th percentiles, respectively.
Figure 3
Figure 3
Glucose levels over time by AID system, FCL+ (blue) and FCL (gray), for the time window from 4 h before dinner to 1.5 h after dinner. A: Percent time<70 (TBR70), time-in-range (TIR), time>180 (TAR180), and time>250 (TAR250). B: CGM and IOB data shown centered over the meal. Black vertical dotted line represents commencement of the meal. Solid blue and black lines and shaded areas represent mean glucose and 25th–75th percentiles, respectively.
See this image and copyright information in PMC

References

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