Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201406000772338 Date of Approval: 17/02/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title micro-needles mediated therapeutic monitoring
Official scientific title Micro-needles-mediated transdermal glucose monitoring in comparison to fingerprick sample analysis
Brief summary describing the background and objectives of the trial Despite of the fact that intensive treatment can greatly reduce the complications which may ensue diabetes, tight monitoring of glucose blood level, remains the corner stone of any effective medical management, especially in type 1 diabetic patients (Ahmed El-laboudi, 2013).Therefore, many research communities have spent their resources and time generously in developing new intelligent diagnostic devices for blood glucose measurement, so as to reduce hyper and hypoglycaemic incidence and complications (Scognamiglio, 2013). Glucose monitoring methods were classified to invasive, minimally invasive, and non-invasive. Devices in the clinical settings and even Self-monitoring devices are considered to be entirely invasive methods for Glucose monitoring. However, most of minimally invasive and non-invasive techniques usually utilize ISF instead of plasma as measurement matrix (Carlos Eduardo Ferrante do Amaral, 2008).Subcutaneous Glucose sensor, was the best example that proved using ISF in TDM in the type-1 diabetic population (Kiang, et al., 2012). Interstitial fluid, ISF, has been proposed to be the best alternative for plasma as a site of TDM. In fact, the composition of ISF highly resembles plasma composition except for the plasma protein. It contains carbohydrates, fatty acids, amino acids, in addition to micro-nutrients and drugs that capable of passing through the cell wall of the capillaries. Samples withdrawal from ISF is potentially non-invasive and painless procedure. Beside, sample preparation and analysis is much easier(Kiang, et al., 2012). In the last decade, micro-needles were demonstrated to be efficient mechanical tool to breach the SC, in order to form micro-channels without stimulation of the under-laying pain nerves (Sivamani, et al., 2007). Our research group work focused on the development of polymeric micro-needle array syst
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MN
Disease(s) or condition(s) being studied Diabetes,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/03/2014
Actual trial start date 02/03/2014
Anticipated date of last follow up 13/03/2014
Actual Last follow-up date 13/03/2014
Anticipated target sample size (number of participants) 14
Actual target sample size (number of participants) 14
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Non-randomised central randomisation by e-mail Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group application of microneedle arrays application of of three microneedle arrays one hour application of 3 microneedle arrays, each one for one hour consequently 14
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
inclusion criteria are: -Healthy - young, human volunteers (7 males, and 7 females) - age between (18-35 years) - students within the school of pharmacy AHFAD University for women and University of Khartoum. exclusion criteria are: ¿ Participants with chronic medical condition ¿ Participants taking regular medications ¿ Smokers ¿ Pregnant and breast feeding women ¿ Participants with current dermatological conditions such as acne, eczema and psoriasis ¿ Age below 18 years old or over 35 years old. 18 Year(s) 35 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/02/2014 Research and ethical review comittee
Ethics Committee Address
Street address City Postal code Country
Alardah street Omdurman 167 Sudan
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome glucose concentration in the interstitial fluid contained in the microneedle -after one hour from the staret of the study. -after 2 hours. after 3 hours.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ahfad university for women Alardah street Omdurman Sudan
FUNDING SOURCES
Name of source Street address City Postal code Country
the principal investigator School of Pharmacy, Ahfad university for women Omdurman 167 Sudan
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor the principal investigator School of Pharmacy, Ahfad university for women Omdurman 167 Sudan Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Dr.Alnada A. AbdAlla Faculty of Pharmacy, university of Khartoum Khartoum 1111 Sudan
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eyman Eltayib Abokara-1983@hotmail.com 00249912272232 School of Pharmacy, Ahfad university for women
City Postal code Country Position/Affiliation
Omdurman 167 Sudan Lecturer
Role Name Email Phone Street address
Public Enquiries Eyman Eltayib Abokara-1983@hotmail.com 00249912272232 School of Phamacy, Ahfad University for Women
City Postal code Country Position/Affiliation
Omdurman 167 Sudan Lecturer
Role Name Email Phone Street address
Scientific Enquiries Eyman Eltayib Abokara-1983@hotmail.com 00249912272232 School of Pharmacy, Ahfad University for woman
City Postal code Country Position/Affiliation
Omdurman 167 Sudan Lecturer
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information