Table 2.
Summary of usability and feasibility studies and RCTa protocols.
| Author, year, reference | Country | App or system name | Focus and study design | Target audience and sample | Key results and outcome variables |
| Peleg, 2017 [34] | Spain | MobiGuide | Feasibility Quasi-experimental |
Intervention: GDMb patients (n=20) Control: historical cohort GDM patients (n=247) Duration: <34th gestational week to delivery (5-11 weeks) |
Intervention vs control: BGc measurement complianced (1.01±0.10 vs 0.87±0.28; P=.03), BP control (98.6/64.7 vs 119.3/72.8 mmHg; P<.001). Patient compliancee: BG measures (0.87±0.11), ketonuria (0.98±0.03), BP (0.82±0.24), responded to message “High BG (2 abnormal per week), did you eat more than you should?” (0.31). Patient satisfaction (rated positive): system increased confidence (12/17), liked system’s adaptability to daily life (12/17), system did not complicate life (15/17); would recommend to others (16/17). Clinician satisfaction (rated positive): system helped identify priorities (6/6), increased patient safety (5/6), easier to manage patients (4/6). |
| Bromuri, 2016 [28] | Switzerland | PHSf | Development, usability, feasibility RCT |
Intervention (telemedicine): GDM patients (n=12) Control (standard protocol): GDM patients (n=12) Duration: 24th-32nd gestational week to delivery (2-4 months) |
Intervention vs control: number of BG measures (2749 vs 1616; P<.001); BG control (5.4 vs 5.7 mmol/L or 98 vs 102.4 mg/dL; P<.001). Intervention group satisfaction: 12/12 satisfied with the care by PHS and perceived the system easy to use. Caregiver satisfaction: perceived the system as appropriate, reduced reaction time, provided possibility of daily consultation, and saved time through automated alerts. |
| Garnweidner-Holme, 2015 [29] | Norway | Pregnant+ | Development, usability | Women with GDM (N=22) Duration: 1-time use of the app |
Perceived ease to register and control BG levels. Participants had success performing given tasks: finding information on healthy eating (10/11), physical activities (10/11), GDM (10/11), finding where to register BG levels (11/11), entering appointments for medical consultations (9/11), and finding how to register body weight (5/11). |
| Borgen, 2017 [35] | Norway | Pregnant+ | RCT protocol (ongoing) | Women with a 2-hour OGTTg ≥9 mmol/L (N=230) Intervention: app + standard care Control: standard care Duration: <33rd gestational week to 3 months postpartum |
BG level measured at 2-hour OGTT 3 months postpartum. Change in health behavior and knowledge about GDM, quality of life, birth weight, mode of delivery, and complications for mother and child. |
| Jo, 2016 [32] | South Korea |
|
Development, usability, feasibility | Usability: GDM patients (n=5) User acceptance test: GDM patients (n=60) Duration: 1 week |
Average usability score: 69.5 out of 100. User acceptance score with behavioral intention to use 5.5, intrinsic motivation score 4.3, perceived ease of use score 4.6, and perceived usefulness score 5.0, out of 7 for all measures. |
| Mackillop, 2014 [33] | United Kingdom | GDm-Health | Development | Beta testing phase: GDM patients (n=7) Service development phase: GDM patients (n=50) Duration: diagnosis to delivery |
Women used the system for 13.1 weeks on average. 46/54 women submitted the minimum of 18 BG readings per week. 19,410/19,686 (98.6%) of BG readings were manually tagged with additional information (time of measurement and comments) by patients. |
| Hirst, 2015 [30] | United Kingdom | GDm-Health | Usability | See row above | Satisfaction: women were satisfied with the care (45/49), and agreed the equipment was convenient (47/49), reliable (43/49), and fit into their lifestyle (42/49). |
| Hirst, 2016 [31] | United Kingdom | GDm-Health | Feasibility | See 2 rows above | 12/41 (29%) women delivered LGAh babies. Mother’s BG (LGA vs non-LGA babies): mean BG (6.3 vs 5.6 mmol/L; P=.004), fasting BG (5.8 vs 5.1 mmol/L; P=.004), and 2-hour postprandial BG (6.9 vs 6.0 mmol/L; P=.001). Odds of delivering an LGA baby increased with every 1-SD increase (0.7 mmol/l) in mean BG (ORi 5.5, 95% CI 1.4-21.2) and mean postprandial BG (OR 6.1, 95% CI 1.6-23.4). |
| Mackillop, 2016 [37] | United Kingdom | GDm-Health | RCT protocol (ongoing) | N=200 pregnant women with abnormal glucose tolerance Intervention: use GDm-Health system (app), attend the clinic every 4-8 weeks Control: standard care, self-record BG diary at home, attend the clinic every 2-4 weeks Duration: 14-34 weeks to delivery |
Efficacy of GDm-Health; BG control and management intensity; maternal and fetal outcomes. |
| Kennelly, 2016 [36] | Ireland | Pears | RCT protocol (ongoing) | N=506 pregnant women, 10-15 weeks’ gestation, body mass index 25-39.9 kg/m2
Intervention: targeted low GIj, nutritional advice, and a daily exercise prescription (in-person education session) with a smartphone app as support, and biweekly follow-up emails Control: standard obstetric care Duration: 2nd to 3rd trimester |
Incidence of GDM at 29 weeks. Gestational weight gain, maternal physical activity levels in the 3rd trimester, and GI and glycemic loading of maternal diet in the 3rd trimester. |
| Skau, 2016 [38] | Malaysia | Jom Mama | RCT protocol (ongoing) | N=660 newly registered married or engaged couples. Female not pregnant, diabetes-free at baseline Intervention: contact with community health promoter: 3 face-to-face meetings, 3 phone calls, communication through WhatsApp group chat, and use of the eHealth platform Control: standard care Duration: 8 months |
Change in abdominal fat content. Change in body mass index, waist-to-height ratio, waist-to-hip ratio, weight, hemoglobin A1c, fasting lipid profile, blood pressure, health literacy, dietary intake, physical activity and sedentary behavior, and stress level. Incidence of GDM. |
aRCT: randomized controlled trial.
bGDM: gestational diabetes mellitus.
cBG: blood glucose.
dNumber of days measured ≥4 BGs/number of days prescribed to measure BG.
eProportion of performed/recommended measurements.
fPHS: personal health system.
gOGTT: oral glucose tolerance test.
hLGA: large for gestational age.
iOR: odds ratio.
jGI: glycemic index.