Diabetes Mellitus Type 2NCT06614283
Advance Health Mobile APP for the Self Management of Diabetes type2
A study testing Diabetes self management @ click in people with Diabetes Mellitus Type 2, run by Universiti Putra Malaysia at 1 site in Pakistan.
Trial summary
Digital health using mobile health (mHealth) tools, such as telehealth and text messaging, and or mobile Apps can improve blood glucose levels in patients with type 2 diabetes. This intervention is designed to improve self-management of diabetes and blood glucose levels in diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Diabetes self management @ click
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Oct 2024to 10 Jun 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The presence of T2D and at least 1 recorded HbA1c level of 8.0% or higher in the past 6 months
- Age between ages 21 and 85 years,
- Receiving primary care at the clinical site
- Having fluency in English/ Urdu in reading and writing
- Having a smartphone
- Agreeing to take part in the study
Who cannot join
- Planning to move away from the study site
- Being pregnant or in lactation, (6) being unable to send or read text messages on a mobile phone,
- Having a history of receiving or planning surgery.
Trial locations and contacts
1 site in 1 country.
Dr. Muhammad Raashed Research coordinator, MPHIL contact
Pakistan1 site
Said Mitha Hospital
Lahore, Punjab Province, 54590
Dr. MUHAMMAD ARSHED, 03337474464, muhammad.arshed@pht.uol.edu.pk
About this study
Official title: Effectiveness of Advance Health Mobile APP for the Self Management of Diabetes type2 in a Resource-constrained Setting, a Randomized Control Trial
Digital health using mobile health (mHealth) tools, such as telehealth and text messaging, and or mobile Apps can improve blood glucose levels in patients with type 2 diabetes. This intervention is designed to improve self-management of diabetes and blood glucose levels in diabetic patients.
Read the detailed description
Patients with type 2 diabetes may experience improvements in their blood glucose levels thanks to mHealth technologies like mobile apps and telehealth text messaging. The goal of this intervention is to help diabetic people better control their blood glucose levels and diabetes. The intervention arm will employ a smartphone application designed specifically for individuals with Type 2 diabetes, with the goal of improving their self-management behaviors. Features of the app include real-time health monitoring, appointment scheduling, medication tracking, patient data storage, treatment and follow-up recommendations, and health education and promotion.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Diabetes self management @ click
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes self management @ clickBehavioural
A mobile application tailored for patients with Type 2 diabetes, aiming to enhance their self-management practices will be used for the intervention arm. The app includes features such as medication tracking, appointment scheduling, patient data storage, advice for treatment and follow-ups, health education and promotion, and real-time health monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Ae mobile application tailored for patients with Type 2 diabetes, aiming to enhance their self-management practices will be used for the intervention arm. The app includes features such as medication tracking, appointment scheduling, patient data storage, advice for treatment and follow-ups, health education and promotion, and real-time health monitoring. Receives: Behavioral: Diabetes self management @ click |
| Control arm | No intervention | The control arm will be given no intervention except usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Self-Management
DSMQ-R will assess Diabetes self-management. The DSMQ-R is a multidimensional questionnaire with 27 items regarding essential self-management practices for T1D and T2D (including diabetes-adjusted eating, glucose testing/monitoring, medication taking, physical activity, and cooperation with the diabetes team). 4 Subscales:
- 'Glucose Management' (GM), 11 items: 1, 4, 6, 10, 12, 21, 22, 23, 24, 26, 27 (10 and 12 must be inverted).
- 'Dietary Control' (DC), 7 items: 2, 5, 9, 13, 17, 18, 25 (5, 13 and 18 must be inverted).
- 'Physical Activity' (PA), 3 items: 8, 11, 15 (11 and 15 must be inverted).
- 'Health-Care Use' (HU), 4 items: 3, 7, 14, 19 (7 and 14 must be inverted). SCALE SCORE = ACTUAL SUM OF ITEMS / MAXIMUM POSSIBLE SUM OF ITEMS x 10
Measured: 6- months from baseline
Secondary outcomes (3)
Hemoglobin A1C
Hemoglobin A1C will be measured by taking blood samples.
Measured: 6- months from baseline
Adherence to medication
SEAMS URDU VERSION WILL BE USED FOR SEAMS Urdu version. It is of 13 questions with a score ranging from 13-39. Higher scores show better adherence
Measured: 6- months from baseline
Health related quality of life
Health-related quality of life will be assessed by EQ 5D3L. The EQ-5D-3L Index score summarizes each possible health state on a numerical scale ranging from -0.594 to 1, where a score of 1 indicates full health and scores of 0 and less than 0 indicate a state equivalent to being dead, and a state
Measured: 6- months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start5 Oct 2024 (estimated)
- Primary completion15 May 2025 (estimated)
- Study completion10 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm randomized control trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arshed Muhammad, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614283
- Sponsor's protocol ID
- BMU
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only study protocol, statistical plan, and results will be shared by publications in peer reviewed journals
Publications
Nelson LA, Greevy RA, Spieker A, Wallston KA, Elasy TA, Kripalani S, Gentry C, Bergner EM, LeStourgeon LM, Williamson SE, Mayberry LS. Effects of a Tailored Text Messaging Intervention Among Diverse Adults With Type 2 Diabetes: Evidence From the 15-Month REACH Randomized Controlled Trial. Diabetes Care. 2021 Jan;44(1):26-34. doi: 10.2337/dc20-0961. Epub 2020 Nov 5.
PubMed 33154039Saydah S, Cowie C, Eberhardt MS, De Rekeneire N, Narayan KM. Race and ethnic differences in glycemic control among adults with diagnosed diabetes in the United States. Ethn Dis. 2007 Summer;17(3):529-35.
PubMed 17985509Choudhry NK, Isaac T, Lauffenburger JC, Gopalakrishnan C, Lee M, Vachon A, Iliadis TL, Hollands W, Elman S, Kraft JM, Naseem S, Doheny S, Lee J, Barberio J, Patel L, Khan NF, Gagne JJ, Jackevicius CA, Fischer MA, Solomon DH, Sequist TD. Effect of a Remotely Delivered Tailored Multicomponent Approach to Enhance Medication Taking for Patients With Hyperlipidemia, Hypertension, and Diabetes: The STIC2IT Cluster Randomized Clinical Trial. JAMA Intern Med. 2018 Sep 1;178(9):1182-1189. doi: 10.1001/jamainternmed.2018.3189.
PubMed 30083727American College of Clinical Pharmacy; McBane SE, Dopp AL, Abe A, Benavides S, Chester EA, Dixon DL, Dunn M, Johnson MD, Nigro SJ, Rothrock-Christian T, Schwartz AH, Thrasher K, Walker S. Collaborative drug therapy management and comprehensive medication management-2015. Pharmacotherapy. 2015 Apr;35(4):e39-50. doi: 10.1002/phar.1563.
PubMed 25884536
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Advance Health Mobile APP for the Self Management of Diabetes type2 in a Resource-constrained Setting, a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06614283
- Acronym / sponsor ID
- BMU
- Conditions
- Diabetes Mellitus Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 5 Oct 2024 (estimated)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 10 Jun 2025 (estimated)
- First posted
- 26 Sep 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.
Digital health using mobile health (mHealth) tools, such as telehealth and text messaging, and or mobile Apps can improve blood glucose levels in patients with type 2 diabetes. This intervention is designed to improve self-management of diabetes and blood glucose levels in diabetic patients.
Detailed description
Patients with type 2 diabetes may experience improvements in their blood glucose levels thanks to mHealth technologies like mobile apps and telehealth text messaging. The goal of this intervention is to help diabetic people better control their blood glucose levels and diabetes. The intervention arm will employ a smartphone application designed specifically for individuals with Type 2 diabetes, with the goal of improving their self-management behaviors. Features of the app include real-time health monitoring, appointment scheduling, medication tracking, patient data storage, treatment and follow-up recommendations, and health education and promotion.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two-arm randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Diabetes self management @ clickAe mobile application tailored for patients with Type 2 diabetes, aiming to enhance their self-management practices will be used for the intervention arm. The app includes features such as medication tracking, appointment scheduling, patient data storage, advice for treatment and follow-ups, health education and promotion, and real-time health monitoring. |
| Control arm | No intervention | –The control arm will be given no intervention except usual care |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The presence of T2D and at least 1 recorded HbA1c level of 8.0% or higher in the past 6 months
- Age between ages 21 and 85 years,
- Receiving primary care at the clinical site
- Having fluency in English/ Urdu in reading and writing
- Having a smartphone
Key exclusion criteria (3 listed)
- Planning to move away from the study site
- Being pregnant or in lactation, (6) being unable to send or read text messages on a mobile phone,
- Having a history of receiving or planning surgery.
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 |
|---|---|---|
| Diabetes self management @ clickA mobile application tailored for patients with Type 2 diabetes, aiming to enhance their self-management practices will be used for the intervention arm. The app includes features such as medication tracking, appointment scheduling, patient data storage, advice for treatment and follow-ups, health education and promotion, and real-time health monitoring. | Behavioural | Intervention arm |
Primary outcome
Diabetes Self-Management
Time frame: 6- months from baseline
DSMQ-R will assess Diabetes self-management. The DSMQ-R is a multidimensional questionnaire with 27 items regarding essential self-management practices for T1D and T2D (including diabetes-adjusted eating, glucose testing/monitoring, medication taking, physical activity, and cooperation with the diabetes team). 4 Subscales: * 'Glucose Management' (GM), 11 items: 1, 4, 6, 10, 12, 21, 22, 23, 24, 26, 27 (10 and 12 must be inverted). * 'Dietary Control' (DC), 7 items: 2, 5, 9, 13, 17, 18, 25 (5, 13 and 18 must be inverted). * 'Physical Activity' (PA), 3 items: 8, 11, 15 (11 and 15 must be inverted). * 'Health-Care Use' (HU), 4 items: 3, 7, 14, 19 (7 and 14 must be inverted). SCALE SCORE = ACTUAL SUM OF ITEMS / MAXIMUM POSSIBLE SUM OF ITEMS x 10
3 secondary outcomes
Hemoglobin A1C
Time frame: 6- months from baseline
Adherence to medication
Time frame: 6- months from baseline
Health related quality of life
Time frame: 6- months from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Results publication: PubMed 33154039Nelson LA, Greevy RA, Spieker A, Wallston KA, Elasy TA, Kripalani S, Gentry C, Bergner EM, LeStourgeon LM, Williamson SE, Mayberry LS. Effects of a Tailored Text Messaging Intervention Among Diverse Adults With Type 2 Diabetes: Evidence From the 15-Month REACH Randomized Controlled Trial. Diabetes Care. 2021 Jan;44(1):26-34. doi: 10.2337/dc20-0961. Epub 2020 Nov 5.
- Results publication: PubMed 17985509Saydah S, Cowie C, Eberhardt MS, De Rekeneire N, Narayan KM. Race and ethnic differences in glycemic control among adults with diagnosed diabetes in the United States. Ethn Dis. 2007 Summer;17(3):529-35.
- Results publication: PubMed 30083727Choudhry NK, Isaac T, Lauffenburger JC, Gopalakrishnan C, Lee M, Vachon A, Iliadis TL, Hollands W, Elman S, Kraft JM, Naseem S, Doheny S, Lee J, Barberio J, Patel L, Khan NF, Gagne JJ, Jackevicius CA, Fischer MA, Solomon DH, Sequist TD. Effect of a Remotely Delivered Tailored Multicomponent Approach to Enhance Medication Taking for Patients With Hyperlipidemia, Hypertension, and Diabetes: The STIC2IT Cluster Randomized Clinical Trial. JAMA Intern Med. 2018 Sep 1;178(9):1182-1189. doi: 10.1001/jamainternmed.2018.3189.
- Results publication: PubMed 25884536American College of Clinical Pharmacy; McBane SE, Dopp AL, Abe A, Benavides S, Chester EA, Dixon DL, Dunn M, Johnson MD, Nigro SJ, Rothrock-Christian T, Schwartz AH, Thrasher K, Walker S. Collaborative drug therapy management and comprehensive medication management-2015. Pharmacotherapy. 2015 Apr;35(4):e39-50. doi: 10.1002/phar.1563.
- Individual participant dataSharing planned: No. Only study protocol, statistical plan, and results will be shared by publications in peer reviewed journals
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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.
Dr. Muhammad Raashed Research coordinator, MPHIL contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes self management @ click in people with Diabetes Mellitus Type 2, run by Universiti Putra Malaysia at 1 site in Pakistan.
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 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 26 Sep 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Muhammad Raashed Research coordinator, MPHIL (00923137774464, muhammad.raashed.eph@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Self-Management (time frame: 6- months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06614283, which also lists 4 linked publications.
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 Sep 2024.