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Figure 1.
Changes in PSI-SF total score and single domains at three and six months vs baseline, by study group (p-values derived from linear mixed models for repeated measures).
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Characteristics BEM Control p* n 40 40 Sex 0.65 Males 57.5% 52.5% Females 42.5% 47.5% Age (years) 10.5 ± 3.9 12.1 ± 3.3 0.06 Education level Primary school 35.3 23.7 Middle school 35.3 36.8 High school 29.4 39.5 Ethnicity 1 Caucasian 100% 97.5% Other − 2.5% Type 1 diabetes duration (years) 4.9 ± 3.2 5.0 ± 3.0 0.70 Type of insulin administration 0.42 CSII (Continuous subcutaneous
insulin infusion)10.0% 5.0% SAP (Sensor-augmented pump) 5.0% 5.0% AID (Automated insulin delivery) 55.0% 72.5% MDI (Multiple Daily Injections) 30.0% 17.5% Type of fast-acting insulin 0.68 Regular human insulin 11.8% 4.0% Aspart 5.9% 12.0% Lispro 82.4% 84.0% Type of basal insulin 0.20 Glargine U100 71.4% 30.0% Glargine U300 28.6% 40.0% Degludec 0.0% 30.0% Last value of HbA1c (%) 6.7 ± 0.7 7.0 ± 0.6 0.14 Method used for glucose monitoring 0.19 FGM (Flash glucose monitoring) 2.5% 10.8% CGM (Continuous glucose monitoring) 97.5% 89.2% Glucometric indices (if CGM) Time in range (70−180 mg/dl) 70.2 ± 9.2 65.9 ± 15.8 0.39 Time below range (TBR) level 1 (< 70 mg/dl) 2.2 ± 2.0 2.2 ± 4.5 0.15 TBR level 2 (< 54 mg/dl) 0.7 ± 0.9 1.8 ± 8.5 0.11 Time above range (TAR) level 1 (> 180 mg/dl) 20.2 ± 7.0 22.3 ± 9.5 0.51 TAR level 2 (> 250 mg/dl) 6.9 ± 5.8 7.7 ± 7.5 0.67 Average blood glucose level (mg/dl) 152.9 ± 17.1 159.8 ± 23.1 0.27 Coefficient of variation (%) 36.3 ± 5.2 34.3 ± 5.9 0.09 Hospitalizations for hypoglycemia
in the past 12 months0 0 − Hospitalizations for ketoacidosis
in the past 12 months0 0 − Episodes of severe hypoglycemia requiring
glucagon administration due to loss of
consciousness or seizures (without
hospitalization)0 0 − Diabetes complications 0 0 − Other chronic diseases Celiac disease 12.5% 5.3% 0.43 Thyroiditis 5.1% 5.3% 1 Data are expressed as frequencies (%) or mean ± SD. * Chi-square test or Fisher's exact test for categorical variables and Mann–Whitney U test for continuous variables. p-values < 0.05 are considered statistically significant. AID, automated insulin delivery; BMI, body mass index; CGM, continuous glucose monitoring; CSII, continuous subcutaneous insulin infusion; CV, coefficient of variation; HbA1c, glycated hemoglobin; MDI, multiple daily injections; TAR, time above range; TBR, time below range; TIR, time in range. Table 1.
Characteristics of the children/adolescents included in the study.
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Characteristics BEM Control p* n 69 70 Civil status 0.25 Single 0.0% 2.5% Married/cohabiting 86.5% 92.5% Separated/divorced 13.5% 5.0% Mother's age 43.2 ± 5.0 44.6 ± 7.3 0.19 Mother's educational level 0.56 Middle school diploma 8.1% 12.8% High school diploma 48.6% 56.4% University degree 43.2% 30.8% Mother's employment status 0.69 Employed 75.7 79.5 Unemployed 24.3 20.5 Retired − − Father's age 46.1 ± 5.8 48.6 ± 7.1 0.12 Father's educational level 0.44 Middle school diploma 11.1% 22.2 High school diploma 55.6% 47.2 University degree 33.3% 30.6 Father's employment status 1 Employed 97.2% 97.2% Unemployed 2.8% 0.0% Retired 0.0% 2.8% Other family members with type 1 diabetes 17.5% 16.2% 0.88 Data are expressed as frequencies (%) or mean ± SD. * Chi-square test or Fisher's exact test for categorical variables and Mann–Whitney U test for continuous variables. p-values < 0.05 are considered statistically significant. Table 2.
Characteristics of parents participating in the study.
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Endpoint Time BEM Control Estimated mean
levels (95% CI)Estimated mean difference
from T0 and 95% CIp-value* Estimated mean
levels (95% CI)Estimated mean difference
from T0 and 95% CIp-value* PSI-SF (total) T0 73.9 (69.0; 78.7) 80.6 (75.8; 85.5) Primary Endpoint T3 69.9 (64.7; 75.1) −3.9 (−7.4; −0.4) 0.03 77.7 (72.6; 82.7) −3.0 (−6.3; 0.4) 0.08 T6 65.4 (60.4; 70.5) −8.4 (−12.4; −4.4) < 0.0001 72.9 (68.1; 77.8) −7.7 (−11.4; −4) < 0.001 PSI-SF parental distress T0 27.4 (25.2; 29.6) 28.7 (26.5; 30.9) T3 24.9 (22.8; 27) −2.5 (−4.2; −0.9) 0.003 27.2 (25.2; 29.3) −1.5 (−3.1; 0.1) 0.07 T6 23.4 (21.3; 25.5) −4.0 (−5.9; −2.1) < 0.0001 25.7 (23.7; 27.7) −3.0 (−4.8; −1.2) 0.001 PSI-SF dysfunctional parent-child interaction T0 19.3 (17.7; 20.9) 22.7 (21.1; 24.3) T3 19.9 (18.1; 21.7) 0.6 (−0.8; 1.9) 0.40 23.0 (21.2; 24.7) 0.3 (−1; 1.6) 0.65 T6 18.3 (16.7; 20) −1.0 (−2.5; 0.5) 0.19 22.0 (20.5; 23.5) −0.7 (−2.1; 0.7) 0.34 PSI-SF difficult child T0 27.1 (25.1; 29.1) 29.2 (27.3; 31.2) T3 25.2 (23.2; 27.3) −1.9 (−3.3; −0.5) 0.01 27.4 (25.4; 29.4) −1.9 (−3.2; −0.5) 0.008 T6 23.8 (21.9; 25.8) −3.3 (−4.9; −1.6) 0.0001 25.2 (23.3; 27.1) −4.1 (−5.6; −2.5) < 0.0001 PHQ-9 T0 5.1 (4.2; 6) 5.7 (4.8; 6.6) T3 4.4 (3.4; 5.3) −0.7 (−1.5; 0.1) 0.1 4.9 (4; 5.8) −0.8 (−1.6; 0) 0.05 T6 4.2 (3.3; 5.1) −0.9 (−1.8; 0) 0.04 4.9 (4.1; 5.7) −0.8 (−1.6; 0) 0.05 GAD-7 T0 5.6 (4.5; 6.7) 6.9 (5.9; 8) T3 4.2 (3.2; 5.2) −1.4 (−2.2; −0.5) 0.001 5.2 (4.3; 6.1) −1.7 (−2.5; −0.9) < 0.0001 T6 4.1 (3.1; 5.1) −1.5 (−2.3; −0.6) 0.001 5.2 (4.2; 6.2) −1.7 (−2.5; −0.9) < 0.0001 B-PSQI C1_Subjective sleep quality T0 1.4 (1.2; 1.5) 1.2 (1; 1.4) T3 1.1 (0.9; 1.3) −0.3 (−0.5; −0.1) 0.001 1.2 (1; 1.3) −0.1 (−0.2; 0.1) 0.45 T6 1.1 (0.9; 1.2) −0.3 (−0.5; −0.1) 0.001 1.2 (1; 1.3) 0.0 (−0.2; 0.1) 0.58 B-PSQI C2_Latency T0 0.8 (0.6; 1) 0.8 (0.6; 1) T3 0.8 (0.6; 1) 0.0 (−0.2; 0.2) 0.85 0.7 (0.5; 0.9) −0.1 (−0.3; 0.1) 0.47 T6 0.7 (0.5; 0.9) −0.1 (−0.3; 0.1) 0.36 0.8 (0.6; 1) 0.0 (−0.2; 0.2) 0.93 B-PSQI C3_Sleep duration T0 1.4 (1.3; 1.6) 1.5 (1.3; 1.7) T3 1.3 (1; 1.5) −0.2 (−0.4; 0) 0.03 1.5 (1.3; 1.7) 0.0 (−0.2; 0.2) 0.85 T6 1.3 (1.1; 1.6) −0.1 (−0.3; 0.1) 0.22 1.6 (1.4; 1.8) 0.1 (−0.1; 0.3) 0.28 B-PSQI C4_Sleep efficiency T0 0.6 (0.4; 0.8) 0.5 (0.3; 0.7) T3 0.7 (0.4; 0.9) 0.1 (−0.2; 0.3) 0.65 0.5 (0.3; 0.7) 0.0 (−0.2; 0.2) 0.93 T6 0.3(0.1; 0.5) −0.3 (−0.5; 0) 0.02 0.6 (0.4; 0.8) 0.1 (−0.1; 0.3) 0.48 B-PSQI C5_Sleep disturbances T0 1.2 (1.1; 1.3) 1.3 (1.1; 1.4) T3 1.1 (0.9; 1.2) −0.1 (−0.3; 0) 0.06 1.2 (1.1; 1.3) −0.1 (−0.2; 0.1) 0.28 T6 1.1 (1; 1.2) −0.1 (−0.3; 0) 0.07 1.1 (1; 1.2) −0.2 (−0.3; 0) 0.02 B-PSQI C6_Use of sleep medications T0 0.2 (0.1; 0.3) 0.1 (0; 0.2) T3 0.0 (0; 0.1) −0.2 (−0.3; 0) 0.02 0.1 (0; 0.1) 0.0 (−0.1; 0.1) 0.691 T6 0.1 (0; 0.2) −0.1 (−0.2; 0) 0.21 0.0 (−0.1; 0.1) −0.1 (−0.2; 0.1) 0.29 B-PSQI C7_Dysfunction during the day T0 0.7 (0.5; 0.9) 0.8 (0.6; 1) T3 0.7 (0.5; 0.8) 0.0 (−0.2; 0.2) 0.66 0.7 (0.6; 0.9) 0.0 (−0.2; 0.1) 0.73 T6 0.6 (0.4; 0.8) −0.1 (−0.3; 0.1) 0.74 0.6 (0.5; 0.8) −0.1 (−0.3; 0.1) 0.19 PSESDM T0 32.1 (31; 33.3) 30.0 (28.9; 31.2) T3 32.9 (31.5; 34.3) 0.8 (−0.5; 2.1) 0.22 30.2 (28.9; 31.6) 0.2 (−1.1; 1.4) 0.77 T6 33.3 (31.9; 34.8) 1.2 (−0.1; 2.6) 0.08 31.3 (30; 32.7) 1.3 (0; 2.6) 0.04 COPE Social support T0 27.1 (25.4; 28.9) 27.6(25.8; 29.3) T3 27.1 (25.2; 29) 0.0 (−1.8; 1.7) 0.98 26.2 (24.3; 28.1) −1.4 (−3; 0.3) 0.1 T6 26.5 (24.6; 28.4) −0.6 (−2.3; 1.1) 0.5 25.4 (23.6; 27.2) −2.2 (−3.9; −0.6) 0.007 COPE Avoidance strategies T0 20.4 (19.3; 21.6) 22.0 (20.9; 23.1) T3 21.3 (20; 22.5) 0.8 (−0.5; 2.1) 0.22 21.4 (20.2; 22.6) −0.6 (−1.9; 0.7) 0.34 T6 20.9 (19.7; 22.1) 0.4 (−0.8; 1.7) 0.49 20.5 (19.4; 21.6) −1.5 (−2.7; −0.3) 0.01 COPE Positive attitude T0 33.0 (31.6; 34.4) 32.8 (31.4; 34.2) T3 33.2 (31.9; 34.6) 0.2 (−1.2; 1.6) 0.74 31.9 (30.6; 33.2) −0.9 (−2.2; 0.5) 0.2 T6 33.0 (31.4; 34.6) 0.0 (−1.5; 1.5) 0.99 32.1 (30.6; 33.6) −0.7 (−2.1; 0.7) 0.34 COPE Problem orientation T0 33.2 (31.7; 34.7) 32.0 (30.5; 33.5) T3 32.9 (31.2; 34.6) −0.3 (−1.8; 1.2) 0.66 30.6 (29; 32.3) −1.4 (−2.9; 0) 0.06 T6 32.5 (30.8; 34.2) −0.7 (−2.3; 0.8) 0.36 30.3 (28.7; 31.9) −1.7 (−3.2; −0.3) 0.02 COPE Transcendent orientation T0 23.4 (22.2; 24.5) 23.4 (22.2; 24.5) T3 23.1 (21.9; 24.2) −0.5 (−1.4; 0.4) 0.31 23.1 (21.9; 24.2) −0.3 (−1.2; 0.5) 0.46 T6 23.6 (22.5; 24.8) −0.8 (−1.8; 0.1) 0.08 23.6 (22.5; 24.8) 0.3 (−0.6; 1.1) 0.57 * Paired t-test derived from linear mixed models for repeated measures. Statistically significant p-values (p < 0.05) are shown in bold. Table 3.
Study results for the primary endpoint and secondary parent-related endpoints: outcomes at three months and six months after participation in the camp.
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Parameters Time BEM BEM Control Control Estimated mean
levels (95% CI)Estimated mean difference
from T0 and 95% CIp-value* Estimated mean
levels (95%CI)Estimated mean difference
from T0 and 95% CIp-value* Between-group
p-value*HbA1c (%) T0 6.7 (6.5; 6.9) 7.0 (6.8; 7.2) 0.65 T3 6.7 (6.5; 7.0) 0.0 (−0.2; 0.3) 0.72 7.1 (6.9; 7.4) 0.1 (−0.1; 0.4) 0.13 T6 6.7 (6.5; 6.9) 0.0 (−0.2; 0.2) 0.99 7.0 (6.8; 7.2) 0.0 (−0.2; 0.2) 0.84 Glucometric indices in the
past 15 d (if using CGM)Time in Range (70−180 mg/dl) T0 70.4 (65.9; 74.8) 66.2 (61.7; 70.6) 0.69 T3 69.6 (64.5; 74.7) −0.7 (−5.8; 4.3) 0.77 67.5 (62.3; 72.8) 1.4 (−3.7; 6.5) 0.59 T6 68.3 (63.3; 73.3) −2.0 (−7.6; 3.5) 0.46 63.9 (58.9; 68.8) −2.3 (−7.7; 3.2) 0.41 Time below range (TBR)
level 1 (< 70 mg/dl)T0 2.3 (1.1; 3.5) 2.2 (1; 3.4) 0.07 T3 7.2 (4.3; 10.2) 5.0 (1.6; 8.3) 0.004 3.0 (−0.1; 6.2) 0.9 (−2.7; 4.4) 0.63 T6 1.9 (0.7; 3.2) −0.4 (−2; 1.3) 0.66 2.4 (1.2; 3.6) 0.2 (−1.4; 1.8) 0.78 Time below range (TBR)
level 2 (< 54 mg/dl)T0 0.7 (−1.5; 2.8) 1.9 (−0.2; 4) 0.30 T3 5.3 (0.4; 10.1) 4.6 (−0.6; 9.8) 0.08 1.4 (−3.7; 6.6) −0.4 (−5.9; 5) 0.88 T6 0.5 (−2.5; 3.6) −0.2 (−4; 3.7) 0.93 2.9 (−0.1; 5.9) 1.0 (−2.8; 4.8) 0.59 Time above range (TAR)
level 1 (> 180 mg/dl)T0 20.4 (17.4; 23.3) 22.3 (19.4; 25.2) 0.07 T3 13.7 (10; 17.4) −6.7 (−10.9; −2.5) 0.002 20.9 (17; 24.9) −1.4 (−5.7; 3) 0.53 T6 21.1 (18.6; 23.5) 0.7 (−2.8; 4.2) 0.70 22.1 (19.7; 24.5) −0.2 (−3.7; 3.2) 0.90 Time above range (TAR)
level 2 (> 250 mg/dl)T0 6.9 (4.6; 9.3) 7.9 (5.6; 10.2) 0.64 T3 4.9 (2.6; 7.3) −2.0 (−4.8; 0.8) 0.17 7.7 (5.3; 10.2) −0.2 (−3; 2.6) 0.9 T6 6.7 (4.4; 8.9) −0.2 (−2.9; 2.4) 0.86 8.7 (6.5; 10.9) 0.8 (−1.8; 3.4) 0.54 Average blood glucose (mg/dl) T0 153.1 (146.2; 160.1) 160.4 (153.6; 167.3) T3 148.8 (141.4; 156.2) −4.3 (−9.8; 1.1) 0.12 161.3 (153.8; 168.9) 0.9 (−4.6; 6.4) 0.74 T6 152.6 (146.4; 158.7) −0.5 (−6.2; 5.1) 0.85 162.1 (156; 168.2) 1.7 (−3.9; 7.3) 0.55 Coefficient of variation T0 36.2 (34.3; 38.1) 34.5 (32.6; 36.4) 0.20 T3 34.7 (32.2; 37.2) −1.5 (−3.9; 0.8) 0.20 34.2 (31.6; 36.7) −0.3 (−2.7; 2.2) 0.83 T6 34.9 (33.1; 36.6) −1.3 (−3.1; 0.4) 0.14 35.4 (33.7; 37.1) 0.9 (−0.8; 2.6) 0.30 * Paired t-test derived from linear mixed models for repeated measures. Statistically significant p-values (p < 0.05) are shown in bold. Table 4.
Secondary endpoints related to children/adolescents – glycemic parameters.
Figures
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Tables
(4)