Diabetes MelletusNCT07180251
Impact of Glycemic Variability on People With Gastrointestinal Cancer and Diabetes After Surgery
A study testing CARE program in people with Diabetes Melletus and Gastrointestinal Cancers, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Melletus, Gastrointestinal Cancers
- What is being tested?
- CARE program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Sep 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Glycemic Variability on Diabetes Self-care, Glycated Hemoglobin, Diabetes Distress, Fatigue, and Quality of Life in People With a Dual Diagnosis of Gastrointestinal Cancer and Diabetes After Surgery
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.
Read the 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
- Being tested
- CARE program, Usual Care
- Keywords
- diabetes mellitus, gastrointestinal cancer, glycemic variability
- Medical subject headings
- Gastrointestinal Neoplasms, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARE programBehavioural
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 CareOther
Usual care means the participants will receive care from their primary care physicians and nurses during clinic visits at the surgical OPD.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before surgery (T0), 3 (T1), 6 (T2), and 12 (T3) months post-surgery
Secondary outcomes (3)
Diabetes Distress Scale
The Diabetes Distress Scale ranges from 15 to 90, with higher scores indicating worse diabetes distress.
Measured: before surgery (T0), 3 (T1), 6 (T2), and 12 (T3) months post-surgery
Fatigue Symptom Inventory
The Fatigue Symptom Inventory total score ranges from 0 to 127, with higher scores indicating worse fatigue.
Measured: before surgery (T0), 3 (T1), 6 (T2), and 12 (T3) months post-surgery
European Organisation for Research and Treatment of Cancer Quality of Life
The global health status/quality of life subscale of the European Organisation for Research and Treatment of Cancer Quality of Life scale ranges from 1 to 7, with higher scores indicating better quality of life.
Measured: before surgery (T0), 3 (T1), 6 (T2), and 12 (T3) months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start8 Sep 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MelletusStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsuan-Ju Kuo, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180251
- Sponsor's protocol ID
- 202501119RIND
- Status last verified
- Aug 2025
- First submitted
- 9 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Glycemic Variability on Diabetes Self-care, Glycated Hemoglobin, Diabetes Distress, Fatigue, and Quality of Life in People With a Dual Diagnosis of Gastrointestinal Cancer and Diabetes After Surgery
- ClinicalTrials.gov ID
- NCT07180251
- Acronym / sponsor ID
- 202501119RIND
- Conditions
- Diabetes Melletus, Gastrointestinal Cancers
- Keywords
- diabetes mellitus, gastrointestinal cancer, glycemic variability
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual care + CARE program | Experimental | Behavioral: CARE program, Other: Usual CareFor 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). |
| Usual Care | Other | Other: Usual CareThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARE programThe 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. | Behavioural | Usual care + CARE program |
| Usual CareUsual care means the participants will receive care from their primary care physicians and nurses during clinic visits at the surgical OPD. | Other | Usual Care, Usual care + CARE program |
Primary outcome
Self-Care of Diabetes Inventory
Time frame: before surgery (T0), 3 (T1), 6 (T2), and 12 (T3) months post-surgery
The Self-Care of Diabetes Inventory total score ranges from 40 to 200, and higher scores mean better diabetes self-care.
3 secondary outcomes
Diabetes Distress Scale
Time frame: before surgery (T0), 3 (T1), 6 (T2), and 12 (T3) months post-surgery
Fatigue Symptom Inventory
Time frame: before surgery (T0), 3 (T1), 6 (T2), and 12 (T3) months post-surgery
European Organisation for Research and Treatment of Cancer Quality of Life
Time frame: before surgery (T0), 3 (T1), 6 (T2), and 12 (T3) months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsuan-Ju Kuo, PhD principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARE program in people with Diabetes Melletus and Gastrointestinal Cancers, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Self-Care of Diabetes Inventory (time frame: before surgery (T0), 3 (T1), 6 (T2), and 12 (T3) months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2025.