PMID- 36226840
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221116
IS  - 2371-4379 (Electronic)
IS  - 2371-4379 (Linking)
VI  - 7
IP  - 4
DP  - 2022 Oct 31
TI  - Clinical Utility of a Digital Therapeutic Intervention in Indian Patients With 
      Type 2 Diabetes Mellitus: 12-Week Prospective Single-Arm Intervention Study.
PG  - e41401
LID - 10.2196/41401 [doi]
LID - e41401
AB  - BACKGROUND: Patients with type 2 diabetes mellitus (T2DM) having elevated levels 
      of blood glucose and glycated hemoglobin (HbA(1c)) are at higher risk of macro- 
      and microvascular complications. Nonetheless, the goal of achieving glycemic 
      control cannot be met with the use of pharmacotherapy alone. The recent emergence 
      of digital therapeutic tools has shown the possibility of improving the 
      modifiable risk factors and self-management of diabetes. OBJECTIVE: The aim of 
      this study was to examine the clinical utility of a digital therapeutic 
      intervention as an add-on therapy to achieve glycemic control in patients with 
      T2DM. METHODS: This was a 12-week prospective, single-arm digital intervention 
      study in patients with T2DM receiving regular antidiabetic treatment. The 
      eligibility criteria included male and female patients with HbA(1c)>/=6.5%, 
      functional English literacy, and a mobile phone capable of running the 
      intervention app. Outcome measures of the study were mean changes in HbA(1c), 
      fasting blood glucose (FBG), postprandial blood glucose (PPBG), BMI, and 
      Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) index at the end of 
      12 weeks. RESULTS: A total of 128 participants completed the study period of 12 
      weeks. There were 54.7% (70/128) men and 45.3% (58/128) women with a mean age of 
      48.48 years (SD 10.27). At the end of 12 weeks, the mean change in HbA(1c), FBG, 
      PPBG, and BMI for the overall study population was -0.84% (P<.001), -8.39 mg/dl 
      (P=.02), -14.97 mg/dl (P<.001), and -0.24 kg/m(2) (P=.06), respectively. Among 
      the participants showing improvement in the HbA(1c) value at the end of 12 weeks 
      (responders), the mean change in HbA(1c), FBG, PPBG, and BMI was -1.24% (P<.001), 
      -12.42 mg/dl (P=.003), -21.45 mg/dl (P<.001), and -0.34 kg/m(2) (P=.007), 
      respectively. There was an increase in HOMA-IR values for the overall study 
      population (0.54, P=.29). HbA(1c) response showed a significant association with 
      a baseline HbA(1c) level >/=7.5%, no prior history of smoking, and no prior 
      COVID-19 infection, as well as with higher levels of program engagement. 
      CONCLUSIONS: A digital therapeutic intervention when used alongside standard 
      medications significantly reduces HbA(1c), FBG, and PPBG levels in patients with 
      T2DM.
CI  - (c)Rajeev Chawla, Shalini Jaggi, Amit Gupta, Ganapathi Bantwal, Suhas Patil. 
      Originally published in JMIR Diabetes (https://diabetes.jmir.org), 31.10.2022.
FAU - Chawla, Rajeev
AU  - Chawla R
AUID- ORCID: 0000-0003-2744-5723
AD  - North Delhi Diabetes Centre, Delhi, India.
FAU - Jaggi, Shalini
AU  - Jaggi S
AUID- ORCID: 0000-0002-1583-2841
AD  - Lifecare Diabetes Centre, Delhi, India.
FAU - Gupta, Amit
AU  - Gupta A
AUID- ORCID: 0000-0002-1221-2217
AD  - Center for Diabetes Care, Greater Noida, India.
FAU - Bantwal, Ganapathi
AU  - Bantwal G
AUID- ORCID: 0000-0003-4343-1719
AD  - Terrals Technologies Private Ltd, Bangaluru, India.
FAU - Patil, Suhas
AU  - Patil S
AUID- ORCID: 0000-0002-3227-9451
AD  - Terrals Technologies Private Ltd, Bangaluru, India.
LA  - eng
PT  - Journal Article
DEP - 20221031
PL  - Canada
TA  - JMIR Diabetes
JT  - JMIR diabetes
JID - 101719410
PMC - PMC9664320
OTO - NOTNLM
OT  - HbA1c
OT  - digital health intervention
OT  - digital therapeutics
OT  - fasting blood glucose
OT  - glycemic control
OT  - mHealth
OT  - mobile health
OT  - postprandial blood glucose
OT  - type 2 diabetes
COIS- Conflicts of Interest: RC, SJ, and AG received research grants from Terrals 
      Technologies Pvt Ltd. SP is an employee of Terrals Technologies Pvt Ltd. GB is an 
      Advisor for Terrals Technologies Pvt Ltd.
EDAT- 2022/10/14 06:00
MHDA- 2022/10/14 06:01
PMCR- 2022/10/31
CRDT- 2022/10/13 08:03
PHST- 2022/07/25 00:00 [received]
PHST- 2022/10/11 00:00 [accepted]
PHST- 2022/09/24 00:00 [revised]
PHST- 2022/10/14 06:00 [pubmed]
PHST- 2022/10/14 06:01 [medline]
PHST- 2022/10/13 08:03 [entrez]
PHST- 2022/10/31 00:00 [pmc-release]
AID - v7i4e41401 [pii]
AID - 10.2196/41401 [doi]
PST - epublish
SO  - JMIR Diabetes. 2022 Oct 31;7(4):e41401. doi: 10.2196/41401.