Type1 Diabetes MellitusNCT05418569
Chinese Smartphone App for 6-18 Years With T1DM - RCT
A study testing Intervention arm - A new smartphone application for pediatric type 1 DM and Standard diabetic eduction in people with Type1 Diabetes Mellitus, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Moving into the era of electronic communication, it changes the way we shall engage our children and adolescents. According to data of the Census and Statistics Department of Hong Kong releases in 2019, more than 80% and up to 99.4% of those aged 10-14 years, and aged 15-24 years respectively had a mobile phone… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Type1 Diabetes Mellitus
- What is being tested?
- Intervention arm - A new smartphone application for pediatric type 1 DM and Standard diabetic eduction
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2021to 1 Jun 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Known type 1 DM diagnosed for at least 6 months
- Aged 6-18 years
- HbA1c >/= 6.0% in the preceding 6 months prior to recruitment
- Receiving DM care in Hong Kong
Who cannot join
- Lack of the ability to use a smartphone application despite an introduction session the smartphone application intended for this study
- Moderate to severe visual impairment that may affect the smartphone application usage
- Cannot read Chinese language.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong Children's Hospital
Hong Kong
Samantha Lee, +852 5741 3307, llk051a@ha.org.hk
About this study
Official title: The Impact of a Locally Tailored Evidence-based Chinese Smartphone Application in Management of Type 1 Diabetes Mellitus Aged 6-18 Years in Hong Kong - a Randomized Controlled Trial
Moving into the era of electronic communication, it changes the way we shall engage our children and adolescents. According to data of the Census and Statistics Department of Hong Kong releases in 2019, more than 80% and up to 99.4% of those aged 10-14 years, and aged 15-24 years respectively had a mobile phone device. A recent survey carried by Kebede et al. (2019) had shown that using diabetes apps was positively associated with self-care behavior in type 1 and type 2 diabetes mellitus (DM). A systematic review carried in Spain by Quevedo Rodríguez et al. (2018) had found most of the available smartphone apps lacked quality certification and very few provide scientific references on their content.
In Hong Kong, there is currently no Chinese smartphone application targeting for the pediatric type 1 population, therefore, most of the education is based on face-to-face or telephone communication with the diabetic nurse and endocrinologists in limited encounters. For families or patients with limited command of English language, apart from one adult oriented DM information smartphone application, the chance of having on-hand mobile device support is truly limited. In light of this context, we shall first design an evidence-based locally tailored Chinese smartphone application for pediatric type 1 DM and then evaluate its effectiveness in improving management of type 1 DM in a robust manner.
The main research question for this project is whether a self-help smartphone application in local Chinese language, tailored to include local clinical practice, culture and food spectrum, can improve diabetes control and psychological wellbeing in patients with type 1 diabetes mellitus aged 6-18 years. Eligible participants will be randomized to either using the smartphone application (on top of standard diabetic care) or continue standard diabetic care. The study aims to compare the difference between the two groups for their diabetic control and the psychological wellbeing.
Read the detailed description
Objectives To evaluate the impact of a locally designed evidence-based Chinese smartphone application in improving type 1 diabetes mellitus management for aged 6-18 years in Hong Kong.
Hypothesis Use of smartphone application can improve diabetes mellitus control and self-care ability, psychological wellbeing and quality of life.
Design and subjects A single-blinded randomized controlled trial employing block randomization. Inclusion criteria: (1) Type 1 diabetes mellitus diagnosed for at least 6 months, (2) Aged 6-18 years, (3) HbA1c >/=6.0%, (4) Receiving DM care in Hong Kong. Exclusion criteria: (1) Lack of the ability to use a smartphone application, (2) Moderate to severe visual impairment, (3) Cannot read Chinese language. Aim for 57 participants in each of the control and intervention arms for a statistical power of 80%.
Study instruments
(1) HemoglobinA1c, (2) Time in range and frequency of hypoglycaemia by continuous glucose monitoring, (3) Chinese versions of PSC-35, PedsQL and DSMQ questionnaires.
Interventions Use of the smartphone application for 6 months.
Main outcome measures Primary outcomes include (1) HbA1c, (2) Time in range, (2) Frequency of hypoglycaemia. Secondary outcomes are scores of PSC-35, PedsQL and DSMQ.
Data analysis and expected results Data to be analysed with intention-to-treat. A post hoc analysis is planned to capture data in the reduced application usage group. Generalized estimating equation will be employed to analyse the data involving within-subject covariance. Around 10% dropout rate assumed. A statistically significant result is defined by a 2-tailed alpha level of 0.05.
- Conditions
- Type1 Diabetes Mellitus
- Being tested
- Intervention arm - A new smartphone application for pediatric type 1 DM, Standard diabetic eduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention arm - A new smartphone application for pediatric type 1 DMDevice
An evidence-based locally tailored Chinese smartphone application for pediatric type 1 DM
Standard diabetic eductionOther
Received standard diabetic care (diabetic nurse education and regular follow-ups) with optional use of an existing smartphone application for general diabetic
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm - Use of the new smartphone application for T1DM | Active comparator | The use of the locally designed smartphone application for T1DM for 6 months, which contained the following domains:
* Type 1 DM self-management information and decision-making algorithm
* Carbohydrate counting information on local food in Hong Kong
* DM day-to-day troubleshooting psychosocial scenarios
* Game-based interactive tools for DM knowledge enhancement
* Usage tracking for each domain of the smartphone application
* Individual participant identification and access code (known to research assistant) Receives: Device: Intervention arm - A new smartphone application for pediatric type 1 DM |
| Control Arm - Standard diabetic education | Placebo comparator | Received standard diabetic care (diabetic nurse education and regular follow-ups) with optional use of an existing smartphone application for general diabetic information for both adult and pediatric population (that encompasses both information for type 1 and type 2 DM) Receives: Other: Standard diabetic eduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
A decrease of 0.5% is considered significant
Measured: 6 months (Assessed at 3 months and 6 months from start of intervention)
CGM data
Time in range, glycemic variability and percentage of hypoglycemia as documented by continuous glucose monitoring (for a period of 2 weeks) at baseline and at the end of study.
Measured: 6 months
Self/Parent-reported questionnaires on hypoglycemia frequency
Self/Parent-reported questionnaires on hypoglycemia frequency, the lowest glucose reading during hypoglycemia and number of severe hypoglycemia requiring glucagon use - to be performed at baseline and at the end of study.
Measured: 6 months
Secondary outcomes (5)
The PSC-35 (Pediatric Symptom Checklist-35 items) questionnaires
The PSC-35 (Pediatric Symptom Checklist-35 items) questionnaires is employed to assess the psychological wellbeing at baseline and at the end of study.
Measured: 6 months
The Chinese version of the Diabetes Self-Management Questionnaire (DSMQ)
The Chinese version of the Diabetes Self-Management Questionnaire (DSMQ) is employed to assess the diabetes self-management behavior at baseline and at the end of study. The data on the questionnaire's use in youths or children are not available yet. We will interpret with caution for those questions not entirely applicable to participants <18 years.
Measured: 6 months
The Chinese version of the Pediatric Quality of Life Inventory 4.0 plus the 3.0 diabetes module
The Chinese version of the Pediatric Quality of Life Inventory 4.0 plus the 3.0 diabetes module to be filled in at baseline and at the end of study.Diabetes module will not be required for participants with ages 5-7 years as Chinese version is currently not available.
Measured: 6 months
Self/Parent-reported questionnaires to assess on carbohydrate counting accuracy on local Hong Kong diet at baseline and at the end of study
Self/Parent-reported questionnaires to assess on carbohydrate counting accuracy on local Hong Kong diet at baseline and at the end of study
Measured: 6 months
Self-reported smartphone application usage satisfaction
Self-reported smartphone application usage satisfaction to be filled at 3 months and the end of study.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Jul 2021
- Primary completion1 May 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEE LAI KA SAMANTHA, Chinese University of Hong Kong
- Investigators
- Samathan Lee, Principal investigator, Hong Kong Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418569
- Sponsor's protocol ID
- PR-HKCH-13
- Status last verified
- Jun 2022
- First submitted
- 29 May 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Locally Tailored Evidence-based Chinese Smartphone Application in Management of Type 1 Diabetes Mellitus Aged 6-18 Years in Hong Kong - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05418569
- Acronym / sponsor ID
- PR-HKCH-13
- Conditions
- Type1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 14 Jun 2022 (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.
Moving into the era of electronic communication, it changes the way we shall engage our children and adolescents. According to data of the Census and Statistics Department of Hong Kong releases in 2019, more than 80% and up to 99.4% of those aged 10-14 years, and aged 15-24 years respectively had a mobile phone device. A recent survey carried by Kebede et al. (2019) had shown that using diabetes apps was positively associated with self-care behavior in type 1 and type 2 diabetes mellitus (DM). A systematic review carried in Spain by Quevedo Rodríguez et al. (2018) had found most of the available smartphone apps lacked quality certification and very few provide scientific references on their content.
In Hong Kong, there is currently no Chinese smartphone application targeting for the pediatric type 1 population, therefore, most of the education is based on face-to-face or telephone communication with the diabetic nurse and endocrinologists in limited encounters. For families or patients with limited command of English language, apart from one adult oriented DM information smartphone application, the chance of having on-hand mobile device support is truly limited. In light of this context, we shall first design an evidence-based locally tailored Chinese smartphone application for pediatric type 1 DM and then evaluate its effectiveness in improving management of type 1 DM in a robust manner.
The main research question for this project is whether a self-help smartphone application in local Chinese language, tailored to include local clinical practice, culture and food spectrum, can improve diabetes control and psychological wellbeing in patients with type 1 diabetes mellitus aged 6-18 years. Eligible participants will be randomized to either using the smartphone application (on top of standard diabetic care) or continue standard diabetic care. The study aims to compare the difference between the two groups for their diabetic control and the psychological wellbeing.
Detailed description
Objectives To evaluate the impact of a locally designed evidence-based Chinese smartphone application in improving type 1 diabetes mellitus management for aged 6-18 years in Hong Kong.
Hypothesis Use of smartphone application can improve diabetes mellitus control and self-care ability, psychological wellbeing and quality of life.
Design and subjects A single-blinded randomized controlled trial employing block randomization. Inclusion criteria: (1) Type 1 diabetes mellitus diagnosed for at least 6 months, (2) Aged 6-18 years, (3) HbA1c >/=6.0%, (4) Receiving DM care in Hong Kong. Exclusion criteria: (1) Lack of the ability to use a smartphone application, (2) Moderate to severe visual impairment, (3) Cannot read Chinese language. Aim for 57 participants in each of the control and intervention arms for a statistical power of 80%.
Study instruments
(1) HemoglobinA1c, (2) Time in range and frequency of hypoglycaemia by continuous glucose monitoring, (3) Chinese versions of PSC-35, PedsQL and DSMQ questionnaires.
Interventions Use of the smartphone application for 6 months.
Main outcome measures Primary outcomes include (1) HbA1c, (2) Time in range, (2) Frequency of hypoglycaemia. Secondary outcomes are scores of PSC-35, PedsQL and DSMQ.
Data analysis and expected results Data to be analysed with intention-to-treat. A post hoc analysis is planned to capture data in the reduced application usage group. Generalized estimating equation will be employed to analyse the data involving within-subject covariance. Around 10% dropout rate assumed. A statistically significant result is defined by a 2-tailed alpha level of 0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm - Use of the new smartphone application for T1DM | Active comparator | Device: Intervention arm - A new smartphone application for pediatric type 1 DMThe use of the locally designed smartphone application for T1DM for 6 months, which contained the following domains: * Type 1 DM self-management information and decision-making algorithm * Carbohydrate counting information on local food in Hong Kong * DM day-to-day troubleshooting psychosocial scenarios * Game-based interactive tools for DM knowledge enhancement * Usage tracking for each domain of the smartphone application * Individual participant identification and access code (known to research assistant) |
| Control Arm - Standard diabetic education | Placebo comparator | Other: Standard diabetic eductionReceived standard diabetic care (diabetic nurse education and regular follow-ups) with optional use of an existing smartphone application for general diabetic information for both adult and pediatric population (that encompasses both information for type 1 and type 2 DM) |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Known type 1 DM diagnosed for at least 6 months
- Aged 6-18 years
- HbA1c >/= 6.0% in the preceding 6 months prior to recruitment
- Receiving DM care in Hong Kong
Key exclusion criteria (3 listed)
- Lack of the ability to use a smartphone application despite an introduction session the smartphone application intended for this study
- Moderate to severe visual impairment that may affect the smartphone application usage
- Cannot read Chinese language.
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 |
|---|---|---|
| Intervention arm - A new smartphone application for pediatric type 1 DMAn evidence-based locally tailored Chinese smartphone application for pediatric type 1 DM | Device | Intervention Arm - Use of the new smartphone application for T1DM |
| Standard diabetic eductionReceived standard diabetic care (diabetic nurse education and regular follow-ups) with optional use of an existing smartphone application for general diabetic | Other | Control Arm - Standard diabetic education |
Primary outcome
HbA1c
Time frame: 6 months (Assessed at 3 months and 6 months from start of intervention)
A decrease of 0.5% is considered significant
CGM data
Time frame: 6 months
Time in range, glycemic variability and percentage of hypoglycemia as documented by continuous glucose monitoring (for a period of 2 weeks) at baseline and at the end of study.
Self/Parent-reported questionnaires on hypoglycemia frequency
Time frame: 6 months
Self/Parent-reported questionnaires on hypoglycemia frequency, the lowest glucose reading during hypoglycemia and number of severe hypoglycemia requiring glucagon use - to be performed at baseline and at the end of study.
5 secondary outcomes
The PSC-35 (Pediatric Symptom Checklist-35 items) questionnaires
Time frame: 6 months
The Chinese version of the Diabetes Self-Management Questionnaire (DSMQ)
Time frame: 6 months
The Chinese version of the Pediatric Quality of Life Inventory 4.0 plus the 3.0 diabetes module
Time frame: 6 months
Self/Parent-reported questionnaires to assess on carbohydrate counting accuracy on local Hong Kong diet at baseline and at the end of study
Time frame: 6 months
Self-reported smartphone application usage satisfaction
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
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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.
Samathan Lee principal investigator
Hong Kong Children's 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 Intervention arm - A new smartphone application for pediatric type 1 DM and Standard diabetic eduction in people with Type1 Diabetes Mellitus, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Jun 2022. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samathan Lee (+852 5741 3307, llk051a@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 6 months (Assessed at 3 months and 6 months from start of intervention)). The study lists 3 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 14 Jun 2022.