deltatrials
Unknown NA INTERVENTIONAL 2-arm NCT03061851

The Individualized Behavioral Intervention of Smartphone App in the Treatment of Type 2 Diabetes Mellitus

A Multicenter, Prospective, Randomized, Controlled Clinical Trial of the Individualized Behavioral Intervention of Smartphone App in the Treatment of Type 2 Diabetes Mellitus

Sponsor: H & J CRO International, Inc.

Updated 7 times since 2017 Last updated: Feb 22, 2017 Started: Jan 25, 2017 Primary completion: Aug 31, 2018 Completion: Dec 31, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This NA trial investigates Diabetes Mellitus, Type 2 and is currently ongoing. H & J CRO International, Inc. leads this study, which shows 7 recorded versions since 2017 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

This study enrolled 400 patients with type 2 diabetes in five centers in Shandong Province, China. Patients with type 2 diabetes who met the inclusion / exclusion criteria were randomly assigned to the trial group (conventional treatment + maltose app) or the control group (conventional treatment) in a 1: 1 ratio. The control group: given conventional hypoglycemic drug treatment, the treatment plan by the investigators according to the patient's condition may be, this study does not interfere. The trial group: the patients were treated with conventional hypoglycemic drugs. The treatment plan was decided by the researcher according to the patient's condition. The intervention was not done in this study. Interventions include: 1. Weekly diabetes-related science articles. 2. Patients reported hypoglycemia or other adverse reactions, the competent physician to deal with. 3. Questionnaires published out the hospital (2 weeks 1), the feedback for the problem. 4. monitoring of abnormal blood glucose data or the presence of related discomfort, can communicate with the competent physician online. 5. Personalize the development of diet, exercise program. 6. different insulin and oral hypoglycemic drug medication time to remind. 7. hypoglycemic drug side effects query.

This study enrolled 400 patients with type 2 diabetes in five centers in Shandong Province, China. Patients with type 2 diabetes who met the inclusion / exclusion criteria were randomly assigned to the trial group (conventional treatment + maltose app) or the control group (conventional treatment) in a 1: 1 ratio.

The control group: given conventional hypoglycemic drug treatment, the treatment plan by the investigators according to the patient's condition may be, this study does not interfere.

The trial group: the patients were treated with conventional hypoglycemic drugs. The treatment plan was decided by the researcher according to the patient's condition. The intervention was not done in this study.

Interventions include:

1. Weekly diabetes-related science articles. 2. Patients reported hypoglycemia or other adverse reactions, the competent physician to deal with. 3. Questionnaires published out the hospital (2 weeks 1), the feedback for the problem. 4. monitoring of abnormal blood glucose data or the presence of related discomfort, can communicate with the competent physician online. 5. Personalize the development of diet, exercise program. 6. different insulin and oral hypoglycemic drug medication time to remind. 7. hypoglycemic drug side effects query.

Status Flow

~Mar 2017 – ~Jun 2018 · 15 months · monthly snapshotRecruiting~Jun 2018 – ~Mar 2019 · 9 months · monthly snapshotRecruiting~Mar 2019 – ~Jan 2021 · 22 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown NA

  2. Sep 2024 — Present [monthly]

    Unknown NA

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown NA

    Status: Unknown StatusUnknown

  4. Jan 2021 — Jul 2024 [monthly]

    Unknown Status NA

  5. Mar 2019 — Jan 2021 [monthly]

    Unknown Status NA

    Status: RecruitingUnknown Status

Show 2 earlier versions
  1. Jun 2018 — Mar 2019 [monthly]

    Recruiting NA

  2. Mar 2017 — Jun 2018 [monthly]

    Recruiting NA

    First recorded

Jan 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • H & J CRO International, Inc.
  • Qingdao Zhixin Health Technology Co., Ltd.
Data source: Qingdao Zhixin Health Technology Co., Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations