Table Ofstudy 1-6 - 114907

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STUDY DESIGN, DURATION,

STUDY AUTHOR, YEAR, COUNTRY PARTICIPANTS, RETENTION


RATE
DialBetics: A novel Smartphone- Kayo Waki et al,2014, Japan RCT, 3 months, 54 participants,
based Self-management Support 77.8% retention
System for Type 2 Diabetes Patients

Effectiveness of Smartphone App- Zhang et al, 2019,China RCT, 6 months, 234


Base Interactive Management participants,
on Glycemic Control In Chinese 82.9% retention
Patients With Poorly Controlled
Diabetes : RCT
Effects of a mobile health diabetes Riangkam et al,2021, Thailand RCT, 3 months, 129 participants,
self -management program 93.8% retention
on HbA1C self- management and
patient satisfaction in adults with
uncontrolled type 2 diabetes: RCT.
Efficacy of Personalized Diabetes Lee et al, 2022, Korea RCT, 26 weeks, 87% retention
Self-care Using
An Electronic Medical Record-
Integrated Mobile App in Patients
With Type 2 Dibetes: 6-Month
Randomized Controlled Trial
The Effect of a Smartphone-Based, Kim et al, 2019, Korea RCT, 24 weeks, 79% retention
Patient-Centered Diabetes Care
System in Patients With Type 2
Diabetes: A Randomized,
Controlled Trial for 24 Weeks
Mobile-Enhanced Peer Support for Caroline et al, 2020, America RCT, 6 months, 120
African Americans participants, 95.8% retention
with Type 2 Diabetes: a Randomized
Controlled Trial
INTERVENTION PRIMARY OUTCOME

Group A - At week 0, participants in the DialBetics group received a HbA1c and FBS values declined
smartphone, NFC-enabled glucometer, and Bluetooth-enabled BP monitor , significantly in the DialBetics group:
pedometer with adapter, and scale, all devices paired with a unique HbA1c decreased an average of 0.4%
communicator that transmitted the readings by wireless network to the compared with an
DialBetics server. participant to take measurements and transmit them average increase of 0.1% in the non-
properly, and to understand the readings. Following each new DialBetics group.
measurement, the patient profile was updated on the server, which DialBetics group FBS decreased an
controlled access to the patients’ data and recorded access history average of 5.5 mg/ dl compared with
a non-DialBetics group average
Group B - would continue their self-care regimen, but they did not receive increase of 16.9 mg/dl
or use any devices to monitor their health data; they did not record their
diet and exercise.

1- Group A - Candidates received usual care and did not install Welltang on Patients in the app interactive
their smartphone. management group
They learned diabetes knowledge and skills by self-learning and had a significantly lower HbA1c level
summarizing, adopted lifestyles and behaviors voluntarily than those in the app self-
management group at 6 months
2- Group B - Candidates requested to install Welltang on their smartphone.
They learned diabetes-related knowledge and skills by using the app,
including glycemic control, diet, exercise, medication, and the use of insulin.
1 clinician is incharged to this group

3- Group C - Candidates installed Welltang, received interactive


management online (service for stable glucose×180 days). 1 dietician and 1
health manager conducted interactive management with patients through
the Welltang platform
Group A - Mobile health diabetes self management program (MHDSMP) HbA1C decreased from 7.80 to 7.17%
Group B - Telephone follow up (TF) in
Group C - Usual care (UC) Mobile health diabetes self
MHDSMP Group - Participants identify DSM problem, management program (MHDSMP)
encourage to set achievable goals and action plan regarding diabetes group
control. App installed on participant’s mobile phone to delivered diabetes-
related knowledge and promoted DSM behaviors. Motivational text
messages also sent to motivate the participants to keep performing DSM
behaviors.

Telephone FollowUp (TF) Group- Monthly telephone follow-up of 15–20


minutes duration was provided by PI, and focused on providing general
health information and DSM, if required, throughout the three month
program.

UC Group- Usual care includes physician visit, clinical examination,


laboratory testing, treatment, health-related, and group-based diabetes
education.
GROUP A- Usual care, The change in HbA1c levels did not
GroupB - Mobile diabetes self- care, differ
Group C - Group with personalized, bidirectional feedback from physicians significantly at 26 weeks among the 3
1- (UC) Group - received Usua lCare according to the standard care for groups
patients with T2DM. perform the SMBG 4 times a day (before a meal in the
morning and 2 hours after every meal), record their glucose levels in a
notebook, and bring the notebook to their clinic visits

2- MC Group - diabetes self-care mobile app (iCareD; Medical Excellence


Inc) was used in addition to the Usual Care for diabetes management.
automated text messages from system were sent to their mobile phones 3
times per week and consisted of 2 standardized messages for DM care and
lifestyle modification.
3-MPC Group- additional personalized recommendations andl feedback to
patients every 2 weeks through the system during the intervention period.
MDIABETIS GROUP A - Control glucose by lifestyle modification HbA1c reduction from baseline was
MDIABETES GROUP B - ON ORAL ANTIDIABETIC WITH LOW RISK HYPOGLYCEMIA greater in the mDiabetes group than
MDIABETES GROUP C-On oral antidiabetic with low risk of hypoglycemia in the pLogbook group .
MDIABETES GROUP D - insulin users
PLOGBOOK GROUP A - Control glucose by lifestyle modification
PLOGBOOK GROUP B - ON ORAL ANTIDIABETIC WITH LOW RISK HYPOGLYCEMIA
PLOGBOOK GROUP C-On oral antidiabetic with low risk of hypoglycemia
PLOGBOOK GROUP D - insulin users
Participants in the mDiabetes group were instructed on how to use the
application and connect with the glucometer and the activity tracker. The
patients in the pLogbook group were instructed to record measured glucose
levels with the same frequency as the mDiabetes group and encouraged to
report if they experienced severe hyperglycemia or hypoglycemia as
adverse events to the study staff. The criteria for the rescue therapy were
same for both groups. At week 12 (visit 5), both mDiabetes and pLogbook
groups, respectively, received advice based on the data on the web and
logbook at the study clinic. At week 6 (visit 4) and week 18 (visit 6),
compliance and adverse events were checked by telephone call. At week 12
(visit 5) and week 24 (visit 7), follow-up anthropometric measurements and
laboratory tests were performed. At week 24, the 7-point SMBG was
checked for 1 day. Participants were not allowed to
changetheiroralantidiabeticmedication and dose unless they required
rescue therapy. The patients in the mDiabetes group were instructed to
follow the recommendation of the insulin dosing algorithm of the
mDiabetes system. In contrast, the patients in the pLogbook group were
instructed to keep their usual way of insulin dose adjustment as had been
previously recommended by their physician and diabetes nurses. At week
12 (visit 5), the study physicians advised on insulin dose titration for the
GROUP A- Participants in the control arm received enhanced usual care Participants in intervention and
through the completion of the community-based DSME course. control groups experienced clinically
meaningful reduction in A1C,

GROUP B - CHWs completed an initial face-to-face visit with participants at


the community-based DSME course, then completed weekly phone calls
with participants for 3 months, followed by monthly calls for 3 months.
CHWs helped participants to choose behavioral goals related to diabetes
selfmanagement and tracked participants’ progress over time. CHWs also
held monthly support groups for study participants.
mHealth web–based application used to connect to members of the
healthcare team.
RISK OF BIAS
SECONDARY OUTCOME
(BEFORE ANALYSIS)

BMI improvement —was greater in the Random sequence generation


DialBetics group. Other clinical variables— Allocation concealment
LDL-C, HDL-C, TG, and BP—remained Blinding of participants and personnel
similar between the 2 groups. Blinding of outcome assessment
Incomplete outcome data
Selective outcome reporting?
Other bias

At month 3 and 6, only group C Random sequence generation


had a significantly lower FPG level than Allocation concealment
that at baseline Blinding of participants and personnel
Blinding of outcome assessment
Incomplete outcome data
Selective outcome reporting?
Other bias
No significant difference in secondary Random sequence generation
outcome Allocation concealment
Blinding of participants and personnel
Blinding of outcome assessment
Incomplete outcome data
Selective outcome reporting?
Other bias
the change in fasting glucose levels, Random sequence generation
weight and BMI Allocation concealment
did not differ among the 3 groups during Blinding of participants and personnel
the 26-week intervention period Blinding of outcome assessment
Incomplete outcome data
Selective outcome reporting?
Other bias
There was no difference in the event Random sequence generation
numbers of severe Allocation concealment
hyperglycemia and hyypoglycemia Blinding of participants and personnel
between the two groups. Blinding of outcome assessment
Incomplete outcome data
Selective outcome reporting?
Other bias
Participants in the intervention group Random sequence generation
experienced Allocation concealment
a significantly larger reduction in diabetes Blinding of participants and personnel
distress compared to the control Blinding of outcome assessment
Incomplete outcome data
Selective outcome reporting?
Other bias

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