UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051372 |
|---|---|
| Receipt number | R000058610 |
| Scientific Title | Assessing the Impact of Mobile-Based Interventions Provided by Pharmacists on Glycemic Control in Adolescent Patients with Type 1 Diabetes Mellitus in Pakistan |
| Date of disclosure of the study information | 2023/06/18 |
| Last modified on | 2023/06/18 20:26:15 |
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Basic information
Public title
Assessing the Impact of Mobile-Based Interventions Provided by Pharmacists on Glycemic Control in Adolescent Patients with Type 1 Diabetes Mellitus in Pakistan
Acronym
MBIPT1DM
Scientific Title
Assessing the Impact of Mobile-Based Interventions Provided by Pharmacists on Glycemic Control in Adolescent Patients with Type 1 Diabetes Mellitus in Pakistan
Scientific Title:Acronym
MBIPT1DM
Region
| Asia(except Japan) |
Condition
Condition
Type 1 Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Glycemic control in adolescents with T1DM
Basic objectives2
Others
Basic objectives -Others
Type 1 diabetic adolescents who used mobile based applications to track their glucose would have a beneficial impact on their glycaemic control indicated by lower haemoglobin A1C (HbA1c) values and decreased number of hospital admissions linked to hypoglycemic or hyperglycemic conditions
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Type 1 diabetic adolescents who used mobile based applications to track their glucose would have a beneficial impact on their glycaemic control indicated by lower haemoglobin A1C (HbA1c) values and decreased number of hospital admissions linked to hypoglycemic or hyperglycemic conditions
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Intervention: use of mobile app for 26 weeks to record glucose levels with at home testing
Interventions/Control_2
Control: no use of mobile app for 26 weeks to record glucose levels with at home testing
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 10 | years-old | <= |
Age-upper limit
| 19 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria were unmarried male and female adolescents diagnosed with Type 1 diabetes > 12 months (to exclude reactions to diagnosis); age 10-19 years (according to the adolescence period defined by WHO), individuals with personal smartphones and were aware of how to download and use basic apps.
Key exclusion criteria
Individuals with Type 2 diabetes mellitus, pregnant, those who were not interested in participating in the study and those who had no smartphones or unaware of app usage were excluded.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Nadia |
| Middle name | |
| Last name | Hussain |
Organization
Al Ain University
Division name
College of Pharmacy
Zip code
64141
Address
Jimi area
TEL
971505440152
nadia.hussain@aau.ac.ae
Public contact
Name of contact person
| 1st name | Nadia |
| Middle name | |
| Last name | Hussain |
Organization
Al Ain University
Division name
College of Pharmacy
Zip code
64141
Address
Jimi Area
TEL
971505440152
Homepage URL
nadia.hussain@aau.ac.ae
Sponsor or person
Institute
Shifa Hospital
Lahore
Pakistan
Institute
Department
Personal name
Funding Source
Organization
Shifa Hospital
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shifa Hospital
Address
Sheikhupura
Tel
923245065017
saimaabasstahammal@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
SH-34987355
Org. issuing International ID_1
SH-34987355
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Shifa Hospital
Lahore
Pakistan
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
125
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 18 | Day |
Last modified on
| 2023 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058610
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
