Table 3.
Outcomes of psychological tests: comparison of treatment and control groups at baseline and at the end of the study.
| Category | Treatment arm | Control arm | Estimated difference (AHCLa – MDIb)c | 95% CI | P value | |||||||
|
|
Baseline | MiniMed 780G AHCL | Baseline | MDI+SMBGd |
|
|
|
|||||
| CISSe | ||||||||||||
|
|
Task-oriented score | 60.67 (7.59) | 58.44 (11.24) | 53.75 (13.53) | 54.75 (13.59) | 4.0f | –10 to 2.0 | .213 | ||||
|
|
Task-oriented sten | 6.44 (1.76) | 6.11 (2.00) | 5.33 (2.32) | 5.53 (1.88) | 1.0f | –10.0 to 2.0 | .237 | ||||
|
|
Emotion-oriented score | 37.33 (9.47) | 32.78 (7.04) | 36.5 (11.51) | 37.12 (13.17) | –4.9 | –10.4 to 0.6 | .077 | ||||
|
|
Emotion-oriented steng | 4.06 (1.83) | 3.17 (1.29 | 3.88 (2.09) | 4.19 (2.59) | –1.1 | –2.2 to 0.0 | .043 | ||||
|
|
Avoidance-oriented score | 37.33 (9.47) | 39.56 (5.96) | 40.88 (10.89) | 36.75 (10.02) | 2.8 | –2.1 to 7.8 | .249 | ||||
|
|
Avoidance-oriented sten | 4.83 (1.92) | 4.50 (1.34) | 5.13 (2.26) | 4.40 (1.84) | 0.2 | –0.7 to 1.2 | .602 | ||||
|
|
Distraction score | 15.94 (4.17) | 15.61 (4.65) | 16.94 (4.80) | 15.00 (4.65) | 0.9 | –1.8 to 3.7 | .506 | ||||
|
|
Distraction sten | 4.28 (1.41) | 4.28 (1.07) | 4.75 (1.84) | 4.00 (1.67) | 0.4 | –0.6 to 1.3 | .468 | ||||
|
|
Social diversion score | 17.00 (3.30) | 16.50 (3.70) | 15.80 (4.90) | 14.80 (4.50) | 2.0f | –1 to 4.0 | .243 | ||||
|
|
Social diversion sten | 5.70 (1.50) | 5.60 (1.60) | 5.10 (2.30) | 4.80 (2.10) | 0.5 | –0.7 to 1.6 | .408 | ||||
| Brief-COPEh | ||||||||||||
|
|
Active coping | 2.41 (0.48) | 2.26 (0.36) | 2.00 (0.80) | 2.20 (0.62) | –0.1 | –0.4 to 0.1 | .278 | ||||
|
|
Planning | 2.44 (0.60) | 2.28 (0.45) | 2.10 (0.81) | 2.00 (0.57) | 0f | –0.5 to 0.5 | .350 | ||||
|
|
Positive reframing | 2.00 (0.52) | 2.28 (0.45) | 1.80 (0.62) | 1.73 (0.82) | 0.5f | 0 to 1 | .094 | ||||
|
|
Acceptance | 2.28 (0.55) | 2.28 (0.48) | 2.03 (0.74) | 2.00 (0.57) | 0.2 | –0.2 to 0.5 | .316 | ||||
|
|
Humor | 1.16 (0.81) | 1.03 (0.69) | 1.10 (0.47) | 1.23 (0.56) | –0.2 | –0.5 to 0.04 | .091 | ||||
|
|
Religion | 0.97 (1.04) | 1.16 (1.08) | 0.93 (0.92) | 0.93 (0.94) | 0.2 | –0.2 to 0.6 | .287 | ||||
|
|
Use of emotional support | 2.09 (0.67) | 2.06 (0.61) | 1.78 (0.93) | 1.72 (0.89) | 0.2 | –0.3 to 0.6 | .470 | ||||
|
|
Use of instrumental support | 2.00 (0.61) | 2.00 (0.52) | 1.60 (1.04) | 1.63 (0.92) | 0.8 | –0.2 to 1.9 | .570 | ||||
|
|
Self-distraction | 1.38 (0.53) | 1.44 (0.48) | 1.27 (0.65) | 1.10 (0.51) | 0.3 | –0.04 to 0.6 | .079 | ||||
|
|
Denial | 0.38 (0.45) | 0.38 (0.45) | 0.62 (0.56) | 0.66 (0.60) | –0.2 | –0.5 to 0.2 | .341 | ||||
|
|
Venting | 1.34 (0.57) | 1.16 (0.54) | 1.33 (0.77) | 1.33 (0.49) | –0.2 | –0.5 to 0.1 | .261 | ||||
|
|
Substance use | 0.32 (0.43) | 0.29 (0.44) | 0.25 (0.41) | 0.22 (0.41) | 0f | 0 to 0.5 | .577 | ||||
|
|
Behavioral disengagement | 0.53 (0.46) | 0.69 (0.57) | 0.60 (0.57) | 0.63 (0.52) | 0.1 | –0.3 to 0.5 | .706 | ||||
|
|
Self-blameg | 1.09 (0.88) | 0.81 (0.68) | 0.83 (0.67) | 1.13 (0.85) | –0.5 | –0.9 to –0.09 | .020 | ||||
| STAIi | ||||||||||||
|
|
STAI X1 scoreg | 38.00 (9.30) | 34.50 (7.80) | 35.00 (8.80) | 38.70 (12.90) | –6.8 | –11.8 to –1.8 | .009 | ||||
|
|
STAI X1 steng | 5.20 (2.20) | 4.60 (2.00) | 4.50 (2.30) | 5.30 (3.00) | –1.4 | –2.5 to –0.3 | .013 | ||||
|
|
STAI X2 scoreg | 41.00 (8.50) | 37.60 (8.40) | 37.90 (9.50) | 38.30 (9.70) | –3.5 | –6.5 to –0.5 | .022 | ||||
|
|
STAI X2 sten | 5.00 (2.50) | 4.30 (2.70) | 4.10 (2.30) | 4.50 (2.20) | <0.001f | –1 to 2.0 | .589 | ||||
| GSESj | ||||||||||||
|
|
GSES score | 30.45 (2.07) | 31.82 (3.89) | 31.75 (3.72) | 30.25 (5.74) | 2.7 | –1.1 to 6.5 | .156 | ||||
|
|
GSES sten | 6.91 (0.83) | 7.27 (1.35) | 7.17 (1.4) | 6.67 (2.27) | 0.8 | –0.6 to 2.2 | .226 | ||||
| PSS-10k | ||||||||||||
|
|
PSS-10 score | 22.58 (3.04) | 21.79 (3.22) | 21.56 (5.55) | 21.75 (4.14) | –0.25 | –2.7 to 2.1 | .833 | ||||
|
|
PSS-10 sten | 7.47 (0.90) | 7.16 (0.96) | 7.12 (1.67) | 7.19 (1.42) | –0.1 | –0.9 to 0.6 | .717 | ||||
| SWLSl | ||||||||||||
|
|
SWLS score | 20.72 (3.29) | 21.94 (4.58) | 21.56 (4.98) | 21.69 (6.11) | 1.0 | –1.9 to 3.8 | .496 | ||||
|
|
SWLS sten | 5.67 (1.08) | 6.11 (1.71) | 5.81 (1.83) | 6.00 (2.19) | –.2 | –0.08 to 1.3 | .662 | ||||
| AISm score | 31.79 (6.01) | 32.89 (5.74) | 32.12 (5.94) | 30.88 (6.11) | 11.4 | –6.6 to 29.5 | .171 | |||||
| MHLCn Scale Form C | ||||||||||||
|
|
Internality score | 26.16 (4.50) | 25.89 (4.88) | 24.12 (6.4) | 25.09 (5.09) | 0.47 | –3.0 to 4.0 | .785 | ||||
|
|
Doctors and other (powerful) people score | 25.21 (5.64) | 24.16 (4.21) | 23.81 (4.74) | 23.53 (5.82) | –0.1 | –3.0 to 2.8 | .928 | ||||
|
|
Chance score | 18.11 (5.92) | 16.58 (5.15) | 20.44 (5.98) | 21.69 (6.11) | –1.4 | –4.0 to 1.2 | .283 | ||||
| PRFo | ||||||||||||
|
|
Awaiting clarification of the disease | 9.25 (2.91) | 7.88 (3.74) | 7.46 (3.67) | 9.00 (3.24) | 1f | 01 to 4.0 | .369 | ||||
|
|
Searching for emotional support | 5.67 (3.2) | 4.67 (4.06) | 5.12 (4.29) | 4.88 (3.40) | –0.3 | –4.3 to 3.6 | .854 | ||||
|
|
Gaining information | 8.94 (2.43) | 8.38 (2.85) | 7.27 (3.33) | 8.13 (3.36) | –0.8 | –2.8 to 1.2 | .425 | ||||
| QoL-Q Diabetesp | ||||||||||||
|
|
Global QoLq score | 187.20 (32.00) | 202.5 0(54.20) | 173.87 (46.24) | 173.60 (53.34) | 19.9 | –17.7 to 57.6 | .287 | ||||
|
|
QoL family relationships/friendships | 9.90 (3.40) | 10.00 (3.50) | 8.27 (3.13) | 10.20 (3.49) | <–0.001f | –2.99 to 2.0 | .604 | ||||
|
|
QoL going out or socializing | 8.20 (2.70) | 8.00 (2.80) | 8.07 (3.43) | 9.33 (2.97) | –1.02 | –3.1 to 1.0 | .311 | ||||
|
|
QoL partner/spouse relationship | 9.80 (3.00) | 9.70 (4.00) | 9.53 (3.34) | 9.73 (4.10) | –0.1 | –3.0 to 2.8 | .943 | ||||
|
|
QoL enjoying sexual activity | 8.40 (2.30) | 8.80 (3.10) | 8.71 (2.43) | 9.21 (3.91) | –0.32 | –2.9 to 2.3 | .797 | ||||
|
|
QoL being physically active | 80 (2.10) | 8.80 (2.80) | 7.47 (3.14) | 8.36 (3.08) | 0.71 | –1.7 to 3.1 | .544 | ||||
|
|
QoL feeling wellg | 7.90 (3.20) | 9.80 (3.10) | 6.73 (3.31) | 7.87 (3.38) | 2.3 | 0.1 to 4.6 | .042 | ||||
|
|
QoL feeling in control of my body | 7.90 (2.50) | 8.70 (3.40) | 7.50 (2.44) | 8.93 (3.59) | <–0.001f | –2.0 to 2.0 | .801 | ||||
|
|
QoL looking good | 7.20 (2.20) | 7.70 (2.50) | 7.79 (2.78) | 8.20 (3.38) | 0.3 | –1.6 to 2.3 | .718 | ||||
|
|
QoL having holidays | 8.90 (3.50) | 9.30 (3.40) | 6.93 (3.01) | 7.53 (2.59) | 1.3 | –0.9 to 3.5 | .234 | ||||
|
|
QoL workingg | 7.40 (2.00) | 10.40 (2.90) | 7.93 (4.15) | 7.33 (3.02) | 2.7 | 0.7 to 4.6 | .010 | ||||
|
|
QoL affording the things I would like | 8.70 (2.70) | 8.90 (3.60) | 8.20 (3.47) | 8.07 (3.20) | 1.4 | –0.9 to 3.7 | .214 | ||||
|
|
QoL driving | 8.60 (3.40) | 9.10 (3.20) | 7.80 (4.18) | 7.93 (3.79) | 0.9 | –1.2 to 3.1 | .393 | ||||
|
|
QoL practicing my religion | 8.40 (3.90) | 8.40 (3.80) | 7.18 (4.33) | 6.30 (3.92) | 0.9 | –0.7 to 2.6 | .249 | ||||
|
|
QoL sleeping | 8.60 (2.50) | 9.8 (3.3) | 7.27 (2.09) | 7.50 (4.31) | 2.1 | –0.3 to 4.5 | .087 | ||||
|
|
QoL eating as I would likeg | 4.90 (2.70) | 7.1 (3.3) | 3.87 (1.88) | 4.07 (2.62) | 3.1 | 0.8 to 5.4 | .011 | ||||
|
|
QoL looking after or being useful to others | 8.90 (2.20) | 8.7 (1.9 | 7.33 (2.47) | 7.31 (3.30) | 2.0f | –4.5 to 4.0 | .081 | ||||
|
|
QoL pets/animals | 7.70 (1.90) | 8.80 (3.70) | 7.09 (2.88) | 6.44 (2.35) | 2.1 | –0.1 to 4.4 | .065 | ||||
|
|
QoL being independent | 9.70 (3.20) | 11.10 (3.10) | 9.80 (2.93) | 9.62 (3.73) | 1.5 | –0.7 to 3.8 | .178 | ||||
|
|
QoL being in control of my life | 9.20 (3.20) | 10.60 (3.50) | 9.20 (3.21) | 8.57 (4.26) | 1.7 | –1.0 to 4.5 | .208 | ||||
|
|
QoL being spontaneous | 6.50 (2.70) | 6.50 (2.70) | 6.67 (3.62) | 6.67 (3.62) | 1f | –2.0 to 4.0 | .430 | ||||
|
|
QoL doing a “normal” thingg | 7.60 (2.90) | 9.90 (3.70) | 8.33 (3.66) | 8.21 (3.85) | 2.8 | 0.2 to 5.4 | .034 | ||||
|
|
QoL being treated as “normal” | 9.00 (2.90) | 9.30 (4.10) | 9.40 (3.14) | 9.36 (4.29) | 0.5 | –2.7 to 3.7 | .750 | ||||
|
|
QoL having confidence | 9.00 (2.20) | 9.30 (3.30) | 8.20 (3.21) | 8.29 (4.10) | –0.9 | –2.8 to 0.9 | .310 | ||||
aAHCL: Advanced Hybrid Closed Loop.
bMDI: multiple daily injection.
cAnalysis of covariance (ANCOVA) with adjustment for the baseline value. The mean difference is presented.
dSMBG: self-monitoring of blood glucose.
eCISS: Coping Inventory for Stressful Situations.
fWilcoxon rank-sum test was applied when ANCOVA assumptions were not meet.
gP<.05.
hBrief-COPE: Brief Coping Orientation to Problems Experienced Inventory.
iSTAI: State-Trait Anxiety Inventory.
jGSES: Generalized Self-Efficacy Scale.
kPSS-10: Perceived Stress Scale 10 Items.
lSWLS: Satisfaction with Life Scale.
mAIS: Acceptance of Illness Scale.
nMHLC: Multidimensional Health Locus of Control.
oPRF: Patient Requests Form.
pQoL-Q Diabetes: Quality of Life in Diabetes Questionnaire.
qQoL: quality of life.