Diabetes Mellitus, Type 1NCT06525454
Individualized Automatic Target Coaching Message for Glycemic Management and Depressive Symptom
A study testing Personalized coaching messages for blood glucose and emotions in people with Diabetes Mellitus, Type 1, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This is a single-center, randomized, prospective, feasibility and acceptability trial in patients with type 1 diabetes. For six weeks, the intervention group will receive weekly personalized coaching messages for glycemic management based on blood data from continuous glucose monitors and bi-weekly personalized… Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Personalized coaching messages for blood glucose and emotions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Aug 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are determined to use continuous glucose monitoring based on their physician's medical judgment.
- Patients with type 1 diabetes, age 20-69 years old
- Currently receiving treatment with multiple insulin injection therapy
- Patients who have access to KakaoTalk via smartphone and are able to communicate with it
- Voluntarily agreed to participate in this clinical study.
Who cannot join
- Subjects using oral hypoglycemic agents
- Steroid and immunosuppressant users
- Subjects receiving anticancer medications
- Breastfeeding or pregnant patients
- Patients who do not voluntarily consent to the study
- Anyone deemed unsuitable by the investigator to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of Individualized Automatic Target Coaching Message Based on the Metrics of Continuous Glucose Monitoring and Depressive Symptom
This is a single-center, randomized, prospective, feasibility and acceptability trial in patients with type 1 diabetes. For six weeks, the intervention group will receive weekly personalized coaching messages for glycemic management based on blood data from continuous glucose monitors and bi-weekly personalized coaching messages for depression management based on depression questionnaires. The control group will remain on their current treatment and will not receive any intervention. The purpose of this trial is to evaluate the feasibility and acceptability of the clinical application of automated, personalized coaching messages for glycemic management and depressive symptom in people with type 1 diabetes.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Personalized coaching messages for blood glucose and emotions
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized coaching messages for blood glucose and emotionsBehavioural
For six weeks, the intervention group will receive weekly personalized coaching messages for glycemic management based on blood data from continuous glucose monitors and bi-weekly personalized coaching messages for depression management based on depression questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Personalized coaching messages for glycemic management and depressive symptoms | Experimental | Not described Receives: Behavioral: Personalized coaching messages for blood glucose and emotions |
| Treatment as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time In Range
Derived from CGM
Measured: Week 6
Secondary outcomes (7)
Diabetes treatment satisfaction
DSTQ
Measured: Week 6
Depressive symptoms
PHQ-9
Measured: Week 6
Time In Tight Range
Derived from CGM
Measured: Week 6
Time Above Range
Derived from CGM
Measured: Week 6
Time Below Range
Derived from CGM
Measured: Week 6
Coefficient of Variation
Derived from CGM
Measured: Week 6
Glycemic Management Indicator
Derived from CGM
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start7 Aug 2024
- Primary completion18 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- 1:2 ratio
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gyuri Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525454
- Sponsor's protocol ID
- 2024-06-077
- Status last verified
- Nov 2024
- First submitted
- 24 Jul 2024
- Last updated
- 13 Nov 2024
- 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 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Individualized Automatic Target Coaching Message Based on the Metrics of Continuous Glucose Monitoring and Depressive Symptom
- ClinicalTrials.gov ID
- NCT06525454
- Acronym / sponsor ID
- 2024-06-077
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 29 Jul 2024 (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.
This is a single-center, randomized, prospective, feasibility and acceptability trial in patients with type 1 diabetes. For six weeks, the intervention group will receive weekly personalized coaching messages for glycemic management based on blood data from continuous glucose monitors and bi-weekly personalized coaching messages for depression management based on depression questionnaires. The control group will remain on their current treatment and will not receive any intervention. The purpose of this trial is to evaluate the feasibility and acceptability of the clinical application of automated, personalized coaching messages for glycemic management and depressive symptom in people with type 1 diabetes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:2 ratio
| Arm | Type | Receives |
|---|---|---|
| Personalized coaching messages for glycemic management and depressive symptoms | Experimental | Behavioral: Personalized coaching messages for blood glucose and emotions |
| Treatment as usual | No intervention | – |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who are determined to use continuous glucose monitoring based on their physician's medical judgment.
- Patients with type 1 diabetes, age 20-69 years old
- Currently receiving treatment with multiple insulin injection therapy
- Patients who have access to KakaoTalk via smartphone and are able to communicate with it
- Voluntarily agreed to participate in this clinical study.
Key exclusion criteria (6 listed)
- Subjects using oral hypoglycemic agents
- Steroid and immunosuppressant users
- Subjects receiving anticancer medications
- Breastfeeding or pregnant patients
- Patients who do not voluntarily consent to the study
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 |
|---|---|---|
| Personalized coaching messages for blood glucose and emotionsFor six weeks, the intervention group will receive weekly personalized coaching messages for glycemic management based on blood data from continuous glucose monitors and bi-weekly personalized coaching messages for depression management based on depression questionnaires. | Behavioural | Personalized coaching messages for glycemic management and depressive symptoms |
Primary outcome
Time In Range
Time frame: Week 6
Derived from CGM
7 secondary outcomes
Diabetes treatment satisfaction
Time frame: Week 6
Depressive symptoms
Time frame: Week 6
Time In Tight Range
Time frame: Week 6
Time Above Range
Time frame: Week 6
Time Below Range
Time frame: Week 6
Coefficient of Variation
Time frame: Week 6
Glycemic Management Indicator
Time frame: Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized coaching messages for blood glucose and emotions in people with Diabetes Mellitus, Type 1, run by Samsung Medical Center at 1 site in South Korea.
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 6 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: finished, as of the sponsor's last update on 13 Nov 2024. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time In Range (time frame: Week 6). 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 13 Nov 2024.