Diabetes Mellitus Type 2
Conditions
Brief 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.
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.
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.
Sponsors
Universiti Putra Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants and Investigators are blinded.
Intervention model description
Two-arm randomized control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Self-Management | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1C | 6- months from baseline | Hemoglobin A1C will be measured by taking blood samples. |
| Adherence to medication | 6- months from baseline | 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 |
| Health related quality of life | 6- months from baseline | 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 |
Countries
Pakistan
Contacts
Primary ContactDr. Muhammad Raashed Research coordinator, MPHIL
Outcome results
None listed