ClinicalTrials.gg
RecruitingNCT07129148Updated Jun 1, 2026

Mobile Health and Wearable Devices for Diabetes Complication Management

An interventional study of Device: No specific devices and Device: CGM,CGM management platform in Diabetes Mellitus Type 2 and Diabetes Mellitus Complications, sponsored by Second Xiangya Hospital of Central South University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by Second Xiangya Hospital of Central South University · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
6,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 908 studies in Diabetes Mellitus, Type 2 with a site in China — 204 open to participants now, 229 under way, 48 of them phase 3. Diabetes Mellitus, Type 2 · China.

Planned enrollment
25th of 767
6,000 · median 199
Started
2025
with 79 others
No phase
194 of 908
56 open now
Primary completion
2026-10
later than 91 of 228 live
Registered
782nd of 908
by date

Among the 908 studies in Diabetes Mellitus, Type 2 with a site in China, this one is the 25th largest by planned enrollment of the 767 interventional ones that give a count, is one of 80 that started in 2025, is one of 194 with no phase, reaches primary completion later than 91 of the 228 other live ones, and was the 782nd registered.

Diabetes Mellitus, Type 2

10,378 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,410 are open to participants now.

Browse Diabetes Mellitus, Type 2 studies →

Open to participants now

204 of the 908 studies in Diabetes Mellitus, Type 2 with a site in China are open now. Recruiting first, the newest first:

199 more — sign in →

All 204 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 882 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 908 studies in Diabetes Mellitus, Type 2 with a site in China, or all of them as a file.
02

Study summary

The value of intelligent lifestyle intervention for T2D and its complications has been initially explored, but evidence-based support for the effectiveness of related AI risk prediction models and intervention models remains to be confirmed. The primary objective of this study is to verify the effectiveness of an AI model for predicting the risk of T2D complications based on phenotype, laboratory indicators and wearable device indicators, and to explore the effect and applicability of an intelligent lifestyle intervention model combining wearable devices and smartphones in preventing T2D complications.

03

Conditions studied

  • Diabetes Mellitus Type 2
  • Diabetes Mellitus Complications
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Confirmed diagnosis of Type 2 Diabetes;
  2. Aged ≥ 18 years;
  3. Able to accept the diabetes management model with AI-assisted management and wearable device monitoring;
  4. Able to provide complete lifestyle records, including medical history, medication status, diet, exercise, etc.;
  5. Fully understand the purpose, nature, and methods of the study, voluntarily participate in this study, accept a 3-month follow-up, and sign the form.

Exclusion criteria

Exclusion Criteria:

  1. Having severe mental illness or language barriers;
  2. Suffering from malignant tumors;
  3. Pregnant or lactating women;
  4. Suspected active infections (such as active pulmonary tuberculosis, pneumonia, etc.);
  5. Severe hepatic and renal insufficiency ( and/or aspartate transaminase > 3 times the ; estimated \< 15 mL/min/1.73 m²);
  6. A history of definite major adverse cardiovascular events and/or revascularization and/or intravenous thrombolysis and/or endovascular thrombectomy;
  7. Uncontrolled hyperthyroidism or hypothyroidism, pituitary-adrenal dysfunction, or other endocrine diseases;
  8. Alcoholism or drug addiction;
  9. Receiving insulin therapy;
  10. Unable to accept new comprehensive intervention technologies for various reasons (such as personal beliefs, economic factors, etc.).
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
6,000 participants (estimated)

Study arms

  • Other
    Control: Traditional Control

    Adopt classic doctor-patient interaction management; receive diet and exercise education upon enrollment, self-monitor blood glucose at home and keep a diary.

    Other: Device: No specific devices

  • Other
    Experimental: Wearable Devices + Data Management Platform

    On the basis of classic management, wear CGM , load CGM management software, and monitor health data in real time via mobile software.

    Other: Device: CGM,CGM management platform

  • Other
    Experimental:WeChat mini-program Smart Management

    On the basis of classic management, use the "Professor Tang" WeChat mini-program for blood glucose recording and diet/exercise management.

    Other: Device: "Professor Tang" WeChat Mini-program

  • Other
    Experimental:Wearable Devices + WeChat mini-program Management

    On the basis of classic management, wear CGM or smartbands , and use the "Professor Tang" WeChat mini-program simultaneously for real-time data monitoring and personalized recommendations.

    Other: Device: CGM, Smart Bracelet, "Professor Tang" WeChat Mini-program

Interventions

  • OtherDevice: No specific devices

    Routine doctor-patient interaction.

  • OtherDevice: CGM,CGM management platform

    Wearable monitoring + CGM management platform-assisted administration

  • OtherDevice: "Professor Tang" WeChat Mini-program

    Mini-program-assisted health management

  • OtherDevice: CGM, Smart Bracelet, "Professor Tang" WeChat Mini-program

    Wearable monitoring + mini-program integrated management

06

What researchers measure

Primary outcomes

  1. HbA1c

    Between-group differences in HbA1c change (from Central Lab)

    Time frame: Baseline, 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Oct 2026, 12 months after the start.

Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 12 months is below that.

Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2025
First posted
Aug 19, 2025
StartActual
Oct 1, 2025
Primary completionEst.
Oct 1, 2026
CompletionEst.
Oct 1, 2027
Last update
Jun 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07129148
Lead sponsor
Second Xiangya Hospital of Central South University
Collaborators
First Hospital of China Medical University, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Harbin Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, First Affiliated Hospital of Kunming Medical University, Tianjin Medical University, Shanghai 6th People's Hospital, Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus, Sinocare
Responsible party
Sponsor
First posted
Aug 19, 2025
Start date
Oct 1, 2025
Primary completion
Oct 1, 2026 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Jun 1, 2026

Study contacts

HouDe Zhou, Prof.
Contact
houdezhou@csu.edu.cn
86-0731-85292223

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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