Digital Health Solutions for Patients With Type 2 Diabetes | NCT07642830

Studies
Digital Health Solutions for Patients With Type 2 Diabetes

NCT07642830

Sponsor

Chang Gung Memorial Hospital

Status

Enrolling by invitation

Last Update Posted

Jun 11, 2026Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Diabetes Mellitus Type 2

Interventions

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 28, 2026Estimated

Primary Completion Date

Jan 4, 2027Estimated

Completion Date

Jan 4, 2027Estimated

First Submitted Date

Jun 8, 2026

First Submission Date that Met QC Criteria

Jun 8, 2026

First Posted Date

Jun 11, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2026

Last Update Posted Date

Jun 11, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

We will conduct a prospective, single-center observational study involving 60 adult T2D patients recruited from Chang Gung Memorial Hospital. Participants will be randomly allocated to either a CGM group or a control group receiving standard care. The intervention group will utilize mobile apps for medication tracking, and a remote communication platform. All participants will collect clinical data-including HbA1c, Time in Range (TIR), insulin use-at baseline and 12 weeks. Patient adherence and satisfaction with CGM will also be assessed.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CGM	Experimental	CGM use in this arm	Device: CGM
Control	No Intervention	Standard care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CGM	Device	Use CGM in the glucose monitoring for CGM arm	CGM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1c	Change in HbA1c	From baseline to week 12
TIR	Improvement in Time in Range	From baseline to week 12

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Patients with confirmed diagnosis of T2D for >1 year, capable of using a smartphone, and willing to sign informed consent.

Exclusion Criteria:

Patients with severe cardiac, hepatic, or renal disease; pregnant women; those participating in other experimental treatments; or unable to follow up.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chang Gung Memorial Hospital		Taoyuan	Taiwan	333	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided