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.: PACTR202309743823347 Date of Approval: 18/09/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Use of continuous glucose monitoring devices among people living with type 1 diabetes in Kenya.
Official scientific title Use of continuous glucose monitoring devices among people living with type 1 diabetes in Kenya: A three-arm pragmatic randomized study on the effectiveness, feasibility, acceptability, and cost.
Brief summary describing the background and objectives of the trial Diabetes mellitus (diabetes) is a chronic condition that represents a major public health and clinical concern. Self-monitoring of blood glucose (SMBG) is a critical part of the care of individuals with diabetes. SMBG entails capillary fingerstick blood glucose testing multiple times per day. Many people with diabetes find this testing painful and cumbersome, often resulting in poor compliance to a glucose self-monitoring schedule. Furthermore, SMBG only provides limited visibility on daily and nightly glucose profiles, meaning that hypo- and hyperglycaemic episodes can be missed or detected with delay. The use of minimally invasive continuous glucose monitoring devices (CGMs) in diabetes management circumvents these challenges as CGMs measure glucose every few minutes over a period of 1-2 weeks through a sensor with a fine needle that is inserted once into a user’s arm or abdomen. This enables periodic glucose measurement without repeat finger pricks and provides the user with a detailed glucose profile over the entire wear time of the sensor, thus enabling better adjustment of therapy or behaviour. In populations where CGMs are accessible to people with diabetes as standard of care and without additional cost, many people with type 1 diabetes have switched from SMBG via fingerstick to the use of CGMs permanently, using the devices continuously. This is rarely possibly for people with type 1 diabetes in the public sector in LMICs as CGMs are not provided as standard of care. Furthermore, it has not been investigated if intermittent, as opposed to continuous use of CGMs provides clinical benefit. Intermittent use could be beneficial for people with diabetes who do not have the means to pay for continuous use of CGMs. This study aims to evaluate the effectiveness, feasibility, acceptability, and cost of intermittent and continuous use of CGM among people with type 1 diabetes in Kenya.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ACCEDE
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 04/09/2023
Actual trial start date
Anticipated date of last follow up 31/10/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 246
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
ClinicalTrials.gov
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Continuous Glucose Monitoring Devices use of CGM in a continuous fashion for 9 months Continuous use for 9 months Continuous Glucose Monitoring (CGM) device is a small electronic tool that you put on your skin, and it tells you the amount of glucose in your body. It is different from a finger prick glucose machine in that you do not need to prick your finger to get some blood to put on the reader paper like you have to do for a finger prick glucose machine 82
Experimental Group Continuous Glucose Monitoring Devices intermittent use of CGM; CGM use for 4 time points consisting of 2 weeks of CGM use each, every three months for the duration of 9 months. Continuous Glucose Monitoring (CGM) device is a small electronic tool that you put on your skin, and it tells you the amount of glucose in your body. It is different from a finger prick glucose machine in that you do not need to prick your finger to get some blood to put on the reader paper like you have to do for a finger prick glucose machine 82
Control Group Self monitoring of blood glucose regular use of SMBG for the duration of 9 months. standard of care 82 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Recipient of care participants are eligible to be included in the Study only if all the following inclusion criteria apply: • People living with T1 diabetes with HbA1c levels ≥10% (with at least 1 measurement over 18 months prior to study enrolment) who are attending for diabetes care at the 3 study clinics. Care givers to children/adolescents living with T1 diabetes are eligible to be included in the study only if all the following inclusion criteria apply: • The child/adolescent that the person is a care giver to is enrolled in the study. Healthcare providers are eligible to be included in the study only if all the following inclusion criteria apply: • Healthcare provider at the study sties engaged in diabetes care provision related to the study. • People living with type 1 diabetes under 4 years of age. • People diagnosed with Type 1 diabetes within the last 2 years. • People who have used a CGM in the last 18 months prior to enrollment • People living with type 2 diabetes. • Known pregnancy at the time of study enrolment. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 4 Year(s) 25 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
No 17/07/2023 Amref Ethics and Scientific Review Committee Amref ESRC
Ethics Committee Address
Street address City Postal code Country
Wilson Airport Langata Road Nairobi 30125 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Comparison of the magnitude of change in HbA1c levels before and after treatment in standard of care, continuous, and intermittent CGM arms (i.e. mean difference in HBA1c levels with their standard deviations, F statistics, p-values) Day 1, Week 2, Week11/12, Week 23/24, week 35/36, week 57/58
Secondary Outcome 1. Estimates of coefficient of variation (CV) for glucose concentrations with 95% confidence intervals, Time in Range (TIR), Time Below Range (TBR), and Time Above Range (TAR) (percentage of time per day and as estimated hours and minutes per day with their 95% confidence intervals) for participants who received the CGM treatments. 2. Number of hospitalizations related to diabetes complications per each group, represented by means and standard deviations. 3. Mixed methods QoL A: survey results including EQ-5D-Y/EQ-5D and Diabetes distress scores at baseline, midpoint, end point of intervention and endpoint of study. B: Qualitative methods FGD among recipients of care and their caregivers 4. Mixed methods: Feasibility will be assessed based on Arm 1 and Arm 2 adherence to protocol in terms of CGM use. Acceptability scores from the GMSS tool at baseline, midline, and end of the intervention period among recipients of care, and results from an acceptability survey from baseline, midline, and endline among recipients of care and their caregivers. Qualitative methods; SSI among health care providers involved in clinical care at the study sites. 5. Costing surveys which capture direct and indirect costs at each follow-up visit among recipients of care, their caregivers and healthcare provider, and at end point of study, modelling over time horizon may be explored. Day 1, Week 2, Week11/12, Week 23/24, week 35/36, week 57/58
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenya Diabetes Management and Information Centre Jadala place, Nairobi Kenya
Machakos Level 5 Hospital Machakos Town Machakos Kenya
Thika Level 5 Hospital General Kago Road Kamenu Thika Town Kiambu Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
The Leona M. and Harry B. Helmsley Charitable Trust 230 Park Avenue New York NY 10169 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Foundation for Innovative New Diagnostics Campus Biotech, Building B, Level 0, Chem. des Mines 9, 1202 Geneva, Switzerland Geneva Switzerland Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Ministry of Health Kenya Afya House, Cathedral Road Nairobi Kenya
Kenya Diabetes Study Group Acs Plaza, Lenana road, Nairobi Kenya
Noncommunicable Diseases Alliance Kenya Mara Road Upperhill Nairobi Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Daniel Katambo dkatambo@gmail.com +254757417404 Nairobi
City Postal code Country Position/Affiliation
Nairobi Kenya DMI
Role Name Email Phone Street address
Public Enquiries Beatrice Vetter Beatrice.Vetter@finddx.org +41077478118 Campus Biotech, Chemin des Mines 9
City Postal code Country Position/Affiliation
Geneva Switzerland Director Noncommunicable Diseases
Role Name Email Phone Street address
Scientific Enquiries Cathy Haldane Cathy.Haldane@finddx.org +27823726496 Campus Biotech
City Postal code Country Position/Affiliation
Geneva Switzerland Sr Scientist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Written informed consent will be obtained from all persons participating in the study, applicable with regulations, including those pertaining to data privacy and participant confidentiality, so as to authorize use and transfer of the data including patient’s biological specimens, medical history and all related data as called for under the protocol. No identifiable personal data shall be exchanged between the sponsor and the investigators. Data sets that contain no participant information, or which will be anonymized, will be deposited in an appropriate data repository and will be shared upon reasonable request Study Protocol within 12 months of the study completion date For FIND-led publications, FIND will ensure that: o All authors have full access to the aggregate study data o No information that allows the retrieval of personal patient data will be shared or published • FIND study data and/or study protocols may be posted in public repositories when required by the journal and/or donor o FIND has no specific preferred repository; if non-FIND authors’ institutions have a repository, it is recommended that this is used, otherwise select from the list of repositories recommended in the journal guidelines
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information