Diabetes (Insulin-requiring, Type 1 or Type 2)NCT07141940
Indonesian-Language Application-Based Guided Imagery Therapy for Insomnia and Glycemic Control in Diabetic Patients
A study testing Indonesian-language application-based auditory guided imagery therapy and Psychoeducation in people with Diabetes (Insulin-requiring, Type 1 or Type 2) and Insomnia Type; Sleep Disorder, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to learn if guided imagery therapy using mobile application in Indonesian language can improve sleep quality and lower fasting blood glucose levels in diabetics patients who have problems with their sleep. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes (Insulin-requiring, Type 1 or Type 2), Insomnia Type; Sleep Disorder, Fasting Plasma Glucose
- What is being tested?
- Indonesian-language application-based auditory guided imagery therapy and Psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteIndonesia
- Study dates
- 6 May 2025to 19 Aug 2025
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients at Endocrinology or Psychosomatic Clinic, Cipto Mangunkusumo Hospital
- Already diagnosed with Diabetes Mellitus
- HbA1c less than 12%
- Insomnia Severity Index more than 8
- Lives in Jakarta, Bogor, Depok, Tangerang, or Bekasi
- Able to understand the Indonesian language well
Who cannot join
- History of amputation or routine hemodialysis
- No device available to connect with the application
- Inability to independently access or use the application
- Inability to perform self-monitoring of blood glucose at home
- Hearing impairment
- Cognitive impairment or intellectual limitations
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Hospital
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: The Role of Indonesian-Language Application-Based Auditory Guided Imagery Therapy on The Reduction of Insomnia Severity Index and Fasting Blood Glucose Levels in Diabetic Patients With Insomnia
The goal of this clinical trial is to learn if guided imagery therapy using mobile application in Indonesian language can improve sleep quality and lower fasting blood glucose levels in diabetics patients who have problems with their sleep.
The main questions it aims to answer are:
Read more
- Can the app-based guided imagery therapy help improve sleep quality in diabetic patients who have trouble sleeping?
- Can the app-based guided imagery therapy help lowering fasting blood glucose in diabetic patients who have trouble sleeping? Researchers will compare app-based guided imagery therapy to education about how to sleep well, to see if the app works to improve sleep quality and lower blood glucose.
Participants will:
- Receive education about how to sleep well
- Use the app 3 times a week for 4 weeks (only for group who receive the app)
- Visit the clinic after 4 weeks for tests
- Conditions
- Diabetes (Insulin-requiring, Type 1 or Type 2), Insomnia Type; Sleep Disorder, Fasting Plasma Glucose
- Being tested
- Indonesian-language application-based auditory guided imagery therapy, Psychoeducation
- Keywords
- guided imagery, relaxation therapy, psycoeducation, insomnia, sleep disorders, fasting blood glucose, diabetes mellitus, Indonesian-language, application-based
- Medical subject headings
- Diabetes Mellitus, Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indonesian-language application-based auditory guided imagery therapyOther
This study used a mobile application developed by researchers using Indonesian language to deliver an auditory guided imagery therapy
PsychoeducationOther
Psychoeducation consists of sleep hygiene and relaxation therapy (breathing exercise, progressive muscle relaxation, and guided imagery)
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The participants receive psychoeducation at the enrollment. Then, they were asked to use the Indonesian-language application-based auditory guided imagery therapy 3 times a week for 4 weeks. Receives: Other: Indonesian-language application-based auditory guided imagery therapy |
| Control Group | Active comparator | The participants receive only psychoeducation at the enrollment. Receives: Other: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
Measured: 4 weeks
Fasting Plasma Glucose
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start6 May 2025
- Primary completion19 Aug 2025
- Study completion19 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes (Insulin-requiring, Type 1 or Type 2)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rudi Putranto, Dr Cipto Mangunkusumo General Hospital
- Investigators
- Rudi Putranto, Internist, MPH, PhD, Principal investigator, Division of Psychosomatic and Palliative, Department of Internal Medicine, Faculty of Medicine Universitas Indonesia - Cipto Mangunkusumo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141940
- Sponsor's protocol ID
- RSCM_IPD_PPM_2025.01
- Status last verified
- Mar 2025
- First submitted
- 19 Aug 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Indonesian-Language Application-Based Auditory Guided Imagery Therapy on The Reduction of Insomnia Severity Index and Fasting Blood Glucose Levels in Diabetic Patients With Insomnia
- ClinicalTrials.gov ID
- NCT07141940
- Acronym / sponsor ID
- RSCM_IPD_PPM_2025.01
- Conditions
- Diabetes (Insulin-requiring, Type 1 or Type 2), Insomnia Type; Sleep Disorder, Fasting Plasma Glucose
- Keywords
- guided imagery, relaxation therapy, psycoeducation, insomnia, sleep disorders, fasting blood glucose, diabetes mellitus, Indonesian-language
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 6 May 2025 (actual)
- Primary completion
- 19 Aug 2025 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 26 Aug 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.
The goal of this clinical trial is to learn if guided imagery therapy using mobile application in Indonesian language can improve sleep quality and lower fasting blood glucose levels in diabetics patients who have problems with their sleep.
The main questions it aims to answer are:
- Can the app-based guided imagery therapy help improve sleep quality in diabetic patients who have trouble sleeping?
- Can the app-based guided imagery therapy help lowering fasting blood glucose in diabetic patients who have trouble sleeping? Researchers will compare app-based guided imagery therapy to education about how to sleep well, to see if the app works to improve sleep quality and lower blood glucose.
Participants will:
- Receive education about how to sleep well
- Use the app 3 times a week for 4 weeks (only for group who receive the app)
- Visit the clinic after 4 weeks for tests
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Indonesian-language application-based auditory guided imagery therapyThe participants receive psychoeducation at the enrollment. Then, they were asked to use the Indonesian-language application-based auditory guided imagery therapy 3 times a week for 4 weeks. |
| Control Group | Active comparator | Other: PsychoeducationThe participants receive only psychoeducation at the enrollment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients at Endocrinology or Psychosomatic Clinic, Cipto Mangunkusumo Hospital
- Already diagnosed with Diabetes Mellitus
- HbA1c less than 12%
- Insomnia Severity Index more than 8
- Lives in Jakarta, Bogor, Depok, Tangerang, or Bekasi
Key exclusion criteria (6 listed)
- History of amputation or routine hemodialysis
- No device available to connect with the application
- Inability to independently access or use the application
- Inability to perform self-monitoring of blood glucose at home
- Hearing impairment
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 |
|---|---|---|
| Indonesian-language application-based auditory guided imagery therapyThis study used a mobile application developed by researchers using Indonesian language to deliver an auditory guided imagery therapy | Other | Intervention Group |
| PsychoeducationPsychoeducation consists of sleep hygiene and relaxation therapy (breathing exercise, progressive muscle relaxation, and guided imagery) | Other | Control Group |
Primary outcome
Insomnia Severity Index
Time frame: 4 weeks
Fasting Plasma Glucose
Time frame: 4 weeks
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 26 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes (Insulin-requiring, Type 1 or Type 2)
Recruiting
Integrating New Skills Into Diabetes Education With CGM
Insulin Dependent Diabetes, Diabetes (DM)
Recruiting
Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes (NEXUS)
Diabetes (Insulin-requiring, Type 1 or Type 2)
RecruitingObservational study
Benefits of Retained Insulin for Good Health
Diabetes (Insulin-requiring, Type 1 or Type 2), Diabetes
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Recruiting
APP-MNT: App-Enhanced Medical Nutrition Therapy on Glycemic Outcomes and Quality of Life
Diabetes (Insulin-requiring, Type 1 or Type 2)
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.
Rudi Putranto, Internist, MPH, PhD principal investigator
Division of Psychosomatic and Palliative, Department of Internal Medicine, Faculty of Medicine Universitas Indonesia - Cipto Mangunkusumo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indonesian-language application-based auditory guided imagery therapy and Psychoeducation in people with Diabetes (Insulin-requiring, Type 1 or Type 2) and Insomnia Type; Sleep Disorder, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
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 6 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 26 Aug 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 Indonesia. 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?
Insomnia Severity Index (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 26 Aug 2025.