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Not yet recruitingNCT06614283Updated Sep 26, 2024

Advance Health Mobile APP for the Self Management of Diabetes Type2

An interventional study of Diabetes self management @ click in Diabetes Mellitus Type 2, sponsored by Universiti Putra Malaysia. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-09-26.

Sponsored by Universiti Putra Malaysia · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
1,600
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Diabetes Mellitus Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 1,600 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Universiti Putra Malaysia is the lead sponsor of 144 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,600 participants (estimated)

Study arms

  • Experimental
    Intervention arm

    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.

    Behavioral: Diabetes self management @ click

  • No intervention
    Control arm

    The control arm will be given no intervention except usual care

Interventions

  • BehavioralDiabetes self management @ click

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6- months from baseline

Secondary outcomes

  1. Hemoglobin A1C

    Hemoglobin A1C will be measured by taking blood samples.

    Time frame: 6- months from baseline

  2. 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

    Time frame: 6- months from baseline

  3. 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

    Time frame: 6- months from baseline

07

Study locations

1 site
08

References and documents

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 33154039 ↗
  • Saydah 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 17985509 ↗
  • Choudhry 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 30083727 ↗
  • American 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 ↗

Individual participant data

Plan to share: No — Only study protocol, statistical plan, and results will be shared by publications in peer reviewed journals

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06614283
Lead sponsor
Universiti Putra Malaysia
Responsible party
Arshed Muhammad (PhD, Universiti Putra Malaysia) — Principal investigator
First posted
Sep 26, 2024
Start date
Oct 5, 2024 (estimated)
Primary completion
May 15, 2025 (estimated)
Completion
Jun 10, 2025 (estimated)
Last update
Sep 26, 2024

Study contacts

Dr. Muhammad Raashed Research coordinator, MPHIL
Contact
muhammad.raashed.eph@gmail.com
00923137774464

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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