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

NCT07180251 | Active Not Recruiting

• 1 other identifier: 202501119RIND
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Melletus; Gastrointestinal Cancers

Keywords

diabetes mellitus; gastrointestinal cancer; glycemic variability

Outcome Measures

Primary Outcomes (1)

• Self-Care of Diabetes Inventory

  The Self-Care of Diabetes Inventory total score ranges from 40 to 200, and higher scores mean better diabetes self-care.

  before surgery (T0), 3 (T1), 6 (T2), and 12 (T3) months post-surgery

Secondary Outcomes (3)

• Diabetes Distress Scale

  before surgery (T0), 3 (T1), 6 (T2), and 12 (T3) months post-surgery

• Fatigue Symptom Inventory

  before surgery (T0), 3 (T1), 6 (T2), and 12 (T3) months post-surgery

• European Organisation for Research and Treatment of Cancer Quality of Life

  before surgery (T0), 3 (T1), 6 (T2), and 12 (T3) months post-surgery

Study Arms (2)

Usual care + CARE program

EXPERIMENTAL

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).

Behavioral: CARE program; Other: Usual Care

Usual Care

OTHER

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).

Other: Usual Care

Interventions

CARE program 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 + CARE program

Usual Care 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; Usual care + CARE program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Hsuan-Ju Kuo, PhD

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In phase 1, a longitudinal, observational design will be used to examine the link between glycemic variability and its predictors and outcomes. In phase 2, a randomized controlled trial design, recruiting participants from three GI surgical OPDs at a medical center in northern Taiwan, will be used. Specifically, after completing the pre-tests, stratification of colorectal, gastric, and pancreatic cancer patients will be performed according to the proportionate of new cases for colorectal, gastric, and pancreatic cancer reported in the National Cancer Registry. investigators will recruit participants who are planning to undergo GI cancer surgery, and participants in the experimental group will begin the 8-week intervention at 3 months postsurgery. Pre-tests will be performed before intervention (T0). The short-term, mid-term, and long-term effects will be measured at 8 weeks (T1; immediately after program completion), 3 months (T2), and 6 months (T3) post-intervention, respectively.

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 18, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: September 18, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)