Aim: To determine whether continuous glucose monitoring (CGM) can reduce hypoglycaemia in patients with post-bariatric hypoglycaemia (PBH). Materials and Methods:In an open-label, nonrandomized, pre-post design with sequential assignment, CGM data were collected in 22 individuals with PBH in two sequential phases: (i) masked (no access to sensor glucose or alarms); and(ii) unmasked (access to sensor glucose and alarms for low or rapidly declining sensor glucose). Twelve participants wore the Dexcom G4 device for a total of 28 days, while 10 wore the Dexcom G6 device for a total of 20 days. Results: Participants with PBH spent a lower percentage of time in hypoglycaemia over 24 hours with unmasked versus masked CGM (<3.3 mM/L, or <60 mg/dL: median [median absolute deviation {MAD}] 0.7 [0.8]% vs. 1.4 [1.7]%, P = 0.03; <3.9 mM/L, or <70 mg/dL: median [MAD] 2.9 [2.5]% vs. 4.7 [4.8]%; P = 0.04), with similar trends overnight. Sensor glucose data from the unmasked phase showed a greater percentage of time spent between 3.9 and 10 mM/L (70-180 mg/dL) (median [MAD] 94.8 [3.9]% vs. 90.8 [5.2]%; P = 0.004) and lower glycaemic variability over 24 hours (median [MAD] mean amplitude of glycaemic excursion 4.1 [0.98] vs. 4.4 [0.99] mM/L; P = 0.04). During the day, participants also spent a greater percentage of time in normoglycaemia with unmasked CGM (median [MAD] 94.2 [4.8]% vs. 90.9 [6.2]%; P = 0.005), largely due to a reduction in hyperglycaemia (>10 mM/L, or 180 mg/dL: median [MAD] 1.9 [2.2]% vs. 3.9 [3.6]%; P = 0.02). Conclusions: Real-time CGM data and alarms are associated with reductions in low sensor glucose, elevated sensor glucose, and glycaemic variability. This suggests CGM allows patients to detect hyperglycaemic peaks and imminent hypoglycaemia, allowing dietary modification and self-treatment to reduce hypoglycaemia. The use of CGM devices may improve safety in PBH, particularly for patients with hypoglycaemia unawareness. ClinicalTrials.gov Identifier: NCT03353415.
Post-bariatric hypoglycemia (PBH) is an increasingly recognized complication of bariatric surgery, with prevalence of up to 36% after gastric bypass. Hypoglycemia typically follows postprandial glycemic spikes. Continuous glucose monitors (CGM) can alert patients to high or low sensor glucose (SG), allowing treatment and prevention of severe hypoglycemia. The aim of this study (NCT03353415) was to determine whether CGM, currently indicated only for diabetes, could reduce hypoglycemia in PBH. In an open label, nonrandomized, pre-post design, sensor glucose data were collected using Dexcom CGM in two sequential phases: (1) masked (no access to SG or alarms); and (2) unmasked (access to SG and alarms for low or rapidly declining SG). Data were available for paired analysis for 22 individuals with PBH (mean±SD age 51.1±13.0 yrs, 20F/2M, BMI 30.6±6.2 kg/m2, 82% with level 3 hypoglycemia and 100% with neuroglycopenia). Participants with PBH spent a lower percentage of time in hypoglycemia with unmasked vs masked CGM (<60 mg/dL, median [MAD]: 0.7 [0.8] vs 1.4 [1.7]%, p=0.03; <70 mg/dL: 2.9 [2.5] vs 4.7 [4.8]%, p=0.04), with similar trends overnight. Likewise, there was more time between 70-180 mg/dL (94.8 [3.9] vs 90.8 [5.2]%, p=0.004), and lower glycemic variability (mean amplitude of glycemic excursion: 74.0 [17.7] vs 79.6 [17.8] mg/dL, p=0.04) during unmasked wear. During the day (6:00 AM-11:59 PM), participants spent more time in normoglycemia with unmasked CGM (94.2 [4.8] vs 90.9 [6.2]%, p=0.005), largely due to reduced hyperglycemia (>180 mg/dL: 1.9 [2.2] vs 3.9 [3.6]%, p=0.02). Availability of real-time CGM data and alarms is associated with reductions in low SG, elevated SG, and glycemic variability. This suggests CGM helps patients detect hyperglycemic peaks and imminent hypoglycemia, allowing dietary modification and self-treatment to reduce hypoglycemia. CGM may thus improve safety in PBH, particularly for patients with hypoglycemia unawareness. Disclosure C.J.Cummings: None. A.Jiang: None. A.L.Sheehan: None. R.Ferraz-bannitz: None. A.Puleio: None. D.C.Simonson: Stock/Shareholder; Phase V Technologies, Inc., GI Windows. J.Dreyfuss: None. M.Patti: Consultant; MBX Biosciences, AstraZeneca, Hanmi Pharm. Co., Ltd., Other Relationship; Fractyl Health, Inc. Funding Diabetes Research Center (P30DK036836)
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