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Diabetes Mellitus, Type 2NCT02726100

SMARTHealth Diabetes in China Using Lay Family Health Promoters

A study testing SMARTHealth Diabetes in people with Diabetes Mellitus, Type 2 and Hypertension, run by The George Institute for Global Health, China at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

It's a community-based parallel-arm cluster Randomized Controlled Trial (RCT). An interactive mobile health management system will be developed to support lay family health promoters and healthcare staff to improve clinical outcomes for family members with Type 2 Diabetes Mellitus (T2DM). Read more about this study

Who is it for?
Ages 40 to 75 years
What is being tested?
SMARTHealth Diabetes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,073 participants
Where
2 sitesChina
Study dates
1 Aug 2017to 28 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Established T2DM
  • HbA1C >= 7%
  • Nominated family member with mobile internet access who agrees to be a family health promoter (FHP)
  • Able to provide informed consent

Who cannot join

  • Psychologically or physically unable to participate the trials.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Hebei Medical University

    Shijiazhuang, Hebei, 050017

  • Center of Disease Control and Prevention, Luquan

    Shijiazhuang, Hebei, 050200

Other trials in China

About this study

Official title: Systematic Medical Assessment, Referral and Treatment for Diabetes Care in China Using Lay Family Health Promoters

It's a community-based parallel-arm cluster Randomized Controlled Trial (RCT). An interactive mobile health management system will be developed to support lay family health promoters and healthcare staff to improve clinical outcomes for family members with Type 2 Diabetes Mellitus (T2DM). 2,000 participants from 80 sites will be chosen from urban (40 communities) and rural (40 villages) settings in Shijiazhuang City, Hebei Province.

Read the detailed description

Study design and Settings:

Cluster randomised controlled trial involving 80 sites (40 communities in urban Shijiazhuang and 40 villages in rural Shijiazhuang) and 2,000 people with T2DM.

Hypothesis:

An interactive mobile health management system can support lay family health promoters (FHP) and healthcare staff to improve clinical outcomes for family members with T2DM

Intervention:

SMARTHealth Diabetes is an interactive mobile health platform to promote improved self-management for people with T2DM. It comprises the following core features:

  • Management support based on best practice clinical guidelines
  • Self-management tools and resources for family members
  • Password protected registration of patients and their nominated FHP to access this information
  • Population of key clinical information into a desktop application used by health care providers when applicable

Community eligibility:

  • 40 urban communities and 40 rural villages from geographically dispersed regions will be selected
  • Each community/ village must have at least one community health station providing services to ≥1,000 adult residents
  • Staff at the community health station must be willing to participate in the intervention

Statistical power:

80 clusters and a mean community cluster size of 25 participants (2,000 total) will provide 90% power to detect an absolute improvement of 10% in the primary outcome. This assumes 20% of people in the control arm will achieve ≥2 'ABC' diabetes goals ((HbA1C<7%; Blood Pressure <140/80 mmHg, LDL cholesterol <100mg/dl or 2.6mmol/L) at end of study; an intra-class correlation coefficient of 0.05, a 20% loss to follow-up, and a 2-sided significance level of 0.05. This translates to a mean reduction of 0.35% for HbA1C, 0.14 mmol/L for LDL cholesterol and 3.4mmHg for systolic BP. Primary analyses will be conducted at the patient level. Secondary analyses will be conducted at the cluster level. Sub-group analyses will be conducted at the community level (based on size and health service characteristics) and patient level (based on demographic factors (co-habitation with FHP) and clinical factors (control rate of 'ABC' risk factors at baseline).

Significance:

The Chinese government has placed prevention and treatment of diabetes as one of 11 National Basic Public Health Services. Despite great promise for mobile health (mHealth) interventions to improve access to effective healthcare, there remains uncertainty about how this can be successfully achieved. These uncertainties pose substantial dilemmas for health system planners. The findings are likely to inform policy on a scalable strategy to overcome sub-optimal access to effective health care in China.

Being tested
SMARTHealth Diabetes
Keywords
Telemedicine, Diabetes Mellitus, Type 2, Decision Support Systems, Clinical, Family Health Promoter, Primary Health Care
Medical subject headings
Diabetes Mellitus, Type 2, Hypertension, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SMARTHealth DiabetesBehavioural

    SMARTHealth Diabetes is an interactive mobile health platform to promote improved self-management for people with T2DM.

Study groups in NCT02726100
Study groupRoleWhat they receive
Intervention armExperimentalParticipants in intervention communities will receive the SMARTHealth Diabetes intervention that connects community health service centers and family health providers for diabetes management. Medical staff and FHPs in the intervention communities will be provided with an initial training session on the installation and use of the platform.
Receives: Behavioral: SMARTHealth Diabetes
Control armNo interventionControl group doesn't use SMARTHealth Diabetes.The "usual-care" in our study will be conducted in a standard way which is defined in the Guidance of National Essential Public Health Service. All the relevant doctors in control group will be trained and required to record the activities defined in the guidance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of patients achieving at least two "ABC" goals

    The proportion of patients achieving at least two "ABC" goals defined as any two of the following: HbA1c <7.0%, blood pressure (BP) <140/80mmHg and LDL cholesterol <100mg/dl or 2.6mmol/L) at 24 months

    Measured: 24 months

Secondary outcomes (9)

  1. The proportion of patients achieving the "A" goal

    The proportion of patients achieving HbA1c <7.0% at 24 months

    Measured: 24 months

  2. The proportion of patients achieving the "B" goal

    The proportion of patients achieving blood pressure (BP) <140/80mmHg at 24 months

    Measured: 24 months

  3. The proportion of patients achieving the "C" goal

    The proportion of patients achieving LDL cholesterol <100mg/dl or 2.6mmol/L at 24 months

    Measured: 24 months

  4. The proportion of patients achieving FPG<7.0 mmol/L

    The proportion of patients achieving FPG<7.0 mmol/L at 24 months

    Measured: 24 months

  5. Mean change in HbA1c level

    Mean change in HbA1c level from baseline to 24 months

    Measured: 24 months

  6. Mean changes in systolic and diastolic blood pressure levels

    Mean changes in systolic and diastolic blood pressure levels from baseline to 24 months

    Measured: 24 months

  7. Mean change in LDL cholesterol level

    Mean change in LDL cholesterol level from baseline to 24 months

    Measured: 24 months

  8. Mean change in FPG level

    Mean change in FPG level from baseline to 24 months

    Measured: 24 months

  9. Mean change in the Summary of Diabetes Self-Care Activities (SDSCA) from baseline to 24 month

    The Summary of Diabetes Self-Care Activities is a scale to measure patients' self-management. The minimum value of each scale item is 0 and the maximum value is 7. Higher scores mean a better outcome.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2016 (estimated)
  2. Study start1 Aug 2017
  3. Primary completion19 Oct 2019
  4. Study completion28 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
2,073 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02726100
Sponsor's protocol ID
APP1094712
Status last verified
Mar 2021
First submitted
22 Mar 2016
Last updated
12 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data are only accessed by investigators.

Publications

  • Ren J, Sun X, Zhang Z, Zhang Y, Xiong S, Tao X, Sun K, Zhang C, Yin B, Zhang X, Peiris D, Zhang P, Ma Y. Baseline body mass index modifies the effects of digital health interventions compared with usual care on cardiovascular disease risk in people with type 2 diabetes: a secondary analysis of the SMARTDiabetes trial. Am J Clin Nutr. 2026 May;123(5):101282. doi: 10.1016/j.ajcnut.2026.101282. Epub 2026 Mar 19.

    PubMed 41862002

  • Tao X, Peiris D, Ma Y, Zhang Y, Song H, Mao L, Zhang P. Real-World Long-Term Engagement With a Mobile App Intervention to Improve Self-Management of Type 2 Diabetes Mellitus in China (SMARTDiabetes): Mixed Methods Study. JMIR Mhealth Uhealth. 2026 Mar 3;14:e76699. doi: 10.2196/76699.

    PubMed 41813427

  • Tao X, Mao L, Zhang P, Ma X, Liang Z, Sun K, Peiris D. Barriers and facilitators to primary care management of type 2 diabetes in Shijiazhuang City, China: a mixed methods study. BMC Prim Care. 2024 Mar 13;25(1):84. doi: 10.1186/s12875-024-02330-7.

    PubMed 38481166

  • Peiris D, Sun L, Patel A, Tian M, Essue B, Jan S, Zhang P. Systematic medical assessment, referral and treatment for diabetes care in China using lay family health promoters: protocol for the SMARTDiabetes cluster randomised controlled trial. Implement Sci. 2016 Aug 17;11(1):116. doi: 10.1186/s13012-016-0481-8.

    PubMed 27535128

Questions about this trial

What is this clinical trial studying?

A study testing SMARTHealth Diabetes in people with Diabetes Mellitus, Type 2 and Hypertension, run by The George Institute for Global Health, China at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of patients achieving at least two "ABC" goals (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02726100, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.

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