Impact of Glycemic Variability on People With Gastrointestinal Cancer and Diabetes After Surgery

NCT ID: NCT07180251

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-08
• Study Completion Date: 2028-07-31

Brief Summary

In study phase 1, the investigators will prospectively examine the factors related to post-operative glycemic variability and its effect on outcomes in people with both DM and GI cancer after surgery. The study will also qualitatively understand the glycemic variability experiences and their associated symptoms and outcomes in people with both DM and GI cancer. In study phase 2, the investigators will develop and test the effects of the CGM-Assisted Reflection Education (CARE) program on adults with both DM and GI cancer post-surgery.

Detailed Description

Diabetes mellitus (DM) often coexists with gastrointestinal (GI) cancer, and poor post-operative glycemic control is hypothesized as a major cause of patients' worse health-related outcomes. No study to date has developed and tested a program that focuses on improving DM self-care through glycemic variability reflection using continuous glucose monitoring (CGM) in people with both GI cancer and DM after surgery. This study aims to (1) prospectively examine the relationships among factors influencing glycemic variability and outcomes (DM self-care, HbA1c, DM distress, fatigue, and quality of life) in adults with DM and GI cancer during the first year post-surgery; (2) qualitatively explore the glycemic variability experiences; and (3) develop and test the effects of the CGM-Assisted Reflection Education (CARE) program on DM self-care and the secondary outcomes. This study consists of two phases. Phase one will utilize a longitudinal mixed-methods design with 200 participants recruited from GI surgical outpatient departments, collecting data via structured questionnaires at four time points: before surgery, 3, 6, and 12 months post-surgery. Data will be analyzed using SPSS version 28 and Mplus version 8.6 under a structural equation modeling approach. A subsample of 21 participants will undergo semi-structured interviews for qualitative insights. In study phase two, the CARE program will be developed and tested using a randomized controlled trial design. A total sample of 60 participants (30 in each group) will be recruited and randomly assigned in a 1:1 ratio to the experimental and the control group. The experimental group will receive usual care plus the CARE program. The control group will receive usual care. Outcomes will be measured using the same set of questionnaires from phase one, and the data will be collected pre-intervention, 8 weeks, 3-, and 6 months after intervention.

Conditions

Diabetes Melletus; Gastrointestinal Cancers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual care + CARE program

For the intervention group, participants will receive usual care and will be scheduled for the first in-person session of the CARE program after completing the T0 questionnaires, and will complete the outcome measurements using structured questionnaires at T1: Post-test 1 (5 months after surgery), T2: Post-test 2(6 months after surgery), and T3: Post-test 3(9 months after surgery).

Group Type: EXPERIMENTAL

CARE program

Intervention Type: BEHAVIORAL

The CARE program is an 8-week intervention using reflection assisted with CGM. The Abbott factory-calibrated Freestyle Libre Flash Glucose Monitoring (Freestyle Libre 2) system will be used to evaluate glycemic variability.

Usual Care

Intervention Type: OTHER

Usual care means the participants will receive care from their primary care physicians and nurses during clinic visits at the surgical OPD.

Usual Care

The control group will receive usual care. After obtaining the participants' written informed consent, baseline data will be collected (T0), and will complete the outcome measurements using structured questionnaires at T1: Post-test 1 (5 months after surgery), T2: Post-test 2 (6 months after surgery), and T3: Post-test 3 (9 months after surgery).

Group Type: OTHER

Usual Care

Intervention Type: OTHER

Usual care means the participants will receive care from their primary care physicians and nurses during clinic visits at the surgical OPD.

Interventions

CARE program

The CARE program is an 8-week intervention using reflection assisted with CGM. The Abbott factory-calibrated Freestyle Libre Flash Glucose Monitoring (Freestyle Libre 2) system will be used to evaluate glycemic variability.

Intervention Type: BEHAVIORAL

Usual Care

Usual care means the participants will receive care from their primary care physicians and nurses during clinic visits at the surgical OPD.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Individuals who are planning to undergo GI cancer surgery according to their physician's advice
• Diagnosed with diabetes mellitus
• Aged 18 or above
• Can communicate in Mandarin or Taiwanese
• Agree to participate and sign the informed consent form

Exclusion Criteria

• People who are under active treatment for cancer other than GI cancer
• Have a cognitive impairment
• Do not know that they have GI cancer
• Have medical-grade adhesives-related allergy (e.g., redness, swelling, heat, pain, itching, blisters or rash)
• Diagnosed with thrombocytopenia or blood coagulation dysfunction

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hsuan-Ju Kuo, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

202501119RIND

Identifier Type: -

Identifier Source: org_study_id