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.: PACTR202402642155729 Date of Approval: 21/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of Self-Monitoring Blood Glucose on Glycemic Control among Insulin-Treated Patients with Diabetes Mellitus in Northeastern Tanzania: A Randomized Controlled Trial
Official scientific title Self-monitoring blood glucose, its associated factors and effect on glycemic control among insulin-treated patients with diabetes at KCMC
Brief summary describing the background and objectives of the trial Background: Tracking of blood glucose levels by patients and care providers remains an integral component in the management of diabetes mellitus. Evidence, primarily from high-income countries, has illustrated the effectiveness of self-monitoring of blood glucose (SMBG) in controlling diabetes. However, there are limited data on the feasibility and impact of SMBG among patients in the rural regions of Sub-Saharan Africa. Objectives: To evaluate SMBG, its associated factors and its effect on glycemic control among insulin-treated patients with diabetes mellitus.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SMBG
Disease(s) or condition(s) being studied Diabetes Mellitus
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/12/2022
Actual trial start date 01/12/2022
Anticipated date of last follow up 31/05/2023
Actual Last follow-up date 31/05/2023
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Structured Self Monitoring of Blood Glucose 3 months (12 weeks) In this arm, participants were provided with an extensive educative intervention, including self-management education on DM and self-monitoring of blood glucose which was a structured staggered SMBG method used. This was done at first contact after eligibility testing and enrolment into the study. They received a Gluconavii glucometer, 50 blood glucose test strips, a logbook, and conducted structured SMBG using the staggered method measuring pre- and post-prandial blood glucose levels everyday throughout the week. Participants in this arm attended an additional study visit compared to the control group to undergo structured SMBG education and training which included self-adjustment of insulin medication dosage according to requirements. The training encompassed the correct method of taking blood glucose readings and how to record them. Participants were instructed to measure their fasting blood glucose levels 2 hours after breakfast, before and 2 hours after their main meal and evening meals alternatively on 7 days each week. Additionally, in the 7th day of each week, participants were asked to perform a blood glucose profile, which involved measuring blood glucose levels at bedtime. The blood glucose meters were calibrated, and readings were checked at each visit. Few recordings from the glucometer were also checked for proper recording methods. Every month during the visit extensive nutritional counselling was also given with education on self-intensification of insulin treatment. Fasting blood glucose was tested at each visit, by a gluconavii glucometer using a fingerstick where participants were instructed to fast for 8 hours before testing. Phone numbers of the study coordinator were provided in case of any questions or queries and also for follow-up purposes. Phone calls were made to participants in the intervention group 1–2 weekly. 39
Control Group Control 3 months (12 weeks) Participants in this arm continued to receive usual DM care which included routine testing. They had routine monthly follow-up consultations, which included fasting blood glucose checks, medications prescription, and measurement of HbA1c levels at baseline and then three months later into the study. 41 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a) DM patients aged above 18 years b) Patients diagnosed with either T1DM or T2DM, and receiving insulin treatment at the time of enrolment, which was started at least 3 months before enrolment c) Patients with HbA1c levels higher than 8% d) Patients who could read or write, or had a reliable guardian who could do so a) Patients with DM above 18 years of age with HbA1c levels higher than 8% who were pregnant b) Patients with a glomerular filtration rate below 15ml/min c) Hemoglobin less than 9g/dL 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 90 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 03/07/2023 National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar es Salaam 11102 Tanzania
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 19/09/2022 Kilimanjaro Christian Medical College Research Ethics and Review Committee
Ethics Committee Address
Street address City Postal code Country
Longuo Moshi 25116 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary endpoint was the reduction of HbA1c, after applying the intervention, by at least 1.2% after 12 weeks. 12 weeks post-intervention
Secondary Outcome The secondary endpoint was the adherence to the intervention, structured SMBG, and its acceptability, as well as the facilitators and barriers associated with the use of the intervention, SMBG, and ability to self-manage DM, which was analyzed after the completion of the intervention which was 12 weeks. 12 weeks post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kilimanjaro Christian Medical Centre Longuo Moshi 25116 United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanzania Diabetes Association Upanga Dar Es Salaam 11103 United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Kilimanjaro Christian Medical University College Longuo Moshi Tanzania University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sophia Muhali muhalisophia@gmail.com +255658767442 Longuo
City Postal code Country Position/Affiliation
Moshi United Republic of Tanzania Medical Resident
Role Name Email Phone Street address
Public Enquiries Nyasatu Chamba nyasatuchamba@yahoo.com +255784327561 Longuo
City Postal code Country Position/Affiliation
Moshi United Republic of Tanzania Physician
Role Name Email Phone Street address
Scientific Enquiries Fatma Muhali muhalifatma@yahoo.co.uk +255787231208 Kijichi
City Postal code Country Position/Affiliation
Dar es Salaam United Republic of Tanzania Endocrinologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification will include text, tables, and figures. Clinical Study Report,Statistical Analysis Plan,Study Protocol From start to end of the study Access criteria will be controlled and upon reasonable request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 13/02/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 19/02/2024 Result - 19/02/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information