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.: PACTR202310817339585 Date of Approval: 05/10/2023
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 South Africa
Official scientific title Use of continuous glucose monitoring devices among people living with type 1 diabetes in South Africa: 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. Little data on effectiveness, feasibility, acceptability, and cost of the use of CGMs in LMIC populations is available to inform clinical models for the integration of CGMs into diabetes management. 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 South Africa.
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
NCT 05944718 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
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 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 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. 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 No intervention Standard of care - regular use of SMBG 9 months Standard of care - regular use of SMBG 82 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Recipients of Care eligibility criteria: People living with type 1 diabetes with current HbA1c levels ≥10% / >86mmol/mol (and for at least 2 measurements over 18 months) attending for diabetes care at the 3 sites. Health care providers eligibility criteria: Healthcare providers at the study sites engaged in diabetes care provision related to the study Recipients of Care exclusion criteria: • 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 6 months prior to enrollment. • People who anticipate that they would have access to a CGM through means outside this study during the duration of the study (15 months). • People living with type 2 diabetes. • Known pregnancy at time of enrolment. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 4 Year(s) 65 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 26/07/2023 University of Pretoria Faculty of Health Sciences Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Tswelopele Building Level 4, Rooms 4-59 and 4-60 Dr Savage Road, Gezina Pretoria 0001 South Africa
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 25/10/2023 University of Cape Town Faculty of Health Sciences Human Research Ethics
Ethics Committee Address
Street address City Postal code Country
Human Research Ethics Committee E 53, Room 46, Old Main Building, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Comparison of the magnitude of change in HbA1c levels (expressed as a percentage and in mmol/mol) before and after treatment in standard of care, continuous and intermittent CGM arms Day 1, Week 2, Week11/12, Week 23/24, week 35/36, week 57/58
Secondary Outcome 2. 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. 3. Number of hospitalizations related to diabetes complications per each group, represented by means and standard deviations. 4. Mixed methods Quality of Life (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 5. 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. 6. Costing surveys which capture direct and indirect costs at each follow-up visit among recipients of care, their caregivers and healthcare providers, 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
Groote Schuur Hospital Diabetes Centre Ward G13, G-Floor. New Groote Schuur Hospital. Observatory Cape Town 7925 South Africa
Red Cross War Memorial Childrens Hospital S14 Diabetes Clinic. Red Cross War Memorial Childrens Hospital, Klipfontein Road, Rondebosch Cape Town 7700 South Africa
Steve Biko Academic Hospital Department of Internal Medicine. Steve Biko Academic Hospital. Room 92436. Steve Biko Road, Gezina Pretoria 0001 South Africa
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 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, Geneva 1202 Switzerland Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
SA Diabetes Advocacy 8 Empire Road, Hout Bay, Cape Town 7806 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Paul Rheeder paul.rheeder@up.ac.za +27123543861 Department of Internal Medicine. Steve Biko Academic Hospital. Room 92436. Steve Biko Road, Gezina
City Postal code Country Position/Affiliation
Pretoria 0001 South Africa University of Pretoria
Role Name Email Phone Street address
Principal Investigator Joel Dave joeldave@endocrine.co.za +27214043861 Division of Endocrinology. Department of Medicine. Faculty of Health Sciences. University of Cape Town. Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa University of Cape Town
Role Name Email Phone Street address
Principal Investigator Michelle Carrihill michelle.carrihill@uct.ac.za +27216585035 S14 Diabetes Clinic. Red Cross War Memorial Childrens Hospital, Klipfontein Road, Rondebosch
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa University of Cape Town
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 Non Communicable Diseases
Role Name Email Phone Street address
Scientific Enquiries Sonjelle Shilton Sonjelle.Shilton@finddx.org +41227100959 Campus Biotech, Chemin des Mines 9
City Postal code Country Position/Affiliation
Geneva Switzerland Deputy Director Operational and Implementation Research
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: All authors have full access to the aggregate study data 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 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