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.: PACTR202102832069874 Date of Approval: 17/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A feasibility CGM trial for patients with type 1 diabetes in Malawi
Official scientific title A feasibility CGM trial for patients with type 1 diabetes followed at a rural, first-level hospital in a low-income country
Brief summary describing the background and objectives of the trial Treatment for type 1 diabetes (T1D) is currently reaching very few of those affected in Malawi. Mostly care is restricted to national or regional centers. Recent efforts have begun to increase access and lower the costs of care by decentralizing services to primary hospitals through nurse-led integrated delivery models (Package of Essential Noncommunicable Disease Interventions/PEN-Plus) in Neno District. These care delivery models are in the process of being codified in collaboration with the World Health Organization. At this stage, it is critical to establish viable strategies to improve glycemic control for patients with T1D as PEN-Plus is adapted and scaled throughout Malawi and other low-resource areas. A recent international consensus statement concluded that continuous glucose data should be considered to help patients with diabetes improve their glycemic control. There is currently a lack of available evidence of the use of technologies that collect this data in low resource settings. This proposed research will help us understand the feasibility and clinical effectiveness of continuous glucose monitor (CGM) use among a largely illiterate rural population of patients with T1D, and the feasibility of CGM technology in rural health facilities and homes to explore viable strategies to raise the standard of care available for people with diabetes in Malawi to the standard of care provided in high resource settings. This study is a 3-month, 2:1 parallel arm closed randomized study of any patient with a T1D diagnosis that is enrolled in the NCD program at two district hospitals in Neno District, Malawi.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Disease monitoring
Anticipated trial start date 17/05/2021
Actual trial start date
Anticipated date of last follow up 30/07/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants)
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
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
Control Group Self monitoring blood glucose which is routine care three to five days per week. one to three times per day. 3 months Patients will continue routine home-based self monitoring of blood glucose by glucose meter and strips. Patient will be provided with all necessary equipment including log book which he/she must bring to clinic visit. 15 Active-Treatment of Control Group
Experimental Group CGM constant, daily 3 months Continuous use of CGM machine will constantly measure blood glucose levels of the patient. This data will be automatically available in the CGM device. Patient must bring this device to the clinic visit. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a T1D diagnosis enrolled in the NCD program at the mentioned PIH-supported facilities Participant must be greater than or equal to 2 year of age pregnant inability of subject or care-provider to use transmitter and applicator 80 and over: 80+ Year,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 2 Year(s) 999 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 11/12/2020 National Health Sciences Research Committee
Ethics Committee Address
Street address City Postal code Country
PO Box 30377 Lilongwe 00000 Malawi
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 22/06/2020 Partners Human Research IRB
Ethics Committee Address
Street address City Postal code Country
399 Revolution Drive, Ste 710 Somerville 02145 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Appropriateness: Several factors will be assessed from both quantitative and qualitative data. The frequency of IT or battery issues will be measured. Additionally, the subjects will be asked questions in qualitative interviews surrounding the ease of use and benefits of such technology in their setting. Fidelity: Several variables will reflect the subjects’ adherence to the utilization of technology as described in the training. These include use of glucose meter, CGM device, log book and the effect on self-management. Acceptability: Subjects and clinical providers will be asked assess their satisfaction with CGM or SMBG technologies, specifically around its content, complexity, comfort, and delivery. Change in HbA1c: This blood test is typically performed in the study setting via point-of-care device and requires a lancet-induced drop of blood from the subject’s fingertip. The resulting percent value reflects the blood glucose level over the past 1-3 months. This will be measured at study enrollment and upon conclusion of the study period. While this is not considered the gold standard in CGM trials, because in this trial we are unsure what proportion of individuals will be able to successfully use their CGM, we are choosing HbA1c as a primary outcome, as we will be able to measure it in all study participants. Data will be collected at the time of test being completed. Severe adverse events: Potential adverse events include infection, local skin reaction, bleeding, hospitalization, hypo- and hyperglycemia. Data sources will include self-reports in log books, readings from CGM and home glucometers, reporting by clinicians and qualitative interviews. baseline and 3 months
Secondary Outcome % Time in range: This value represents the proportion of blood glucose readings observed by the subject which are within the normal range of blood glucose levels. This will be measured using CGM and logbooks in the intervention arm, and SBGM and logbooks in the comparison arm. All-cause mortality: The proportion of subjects who die, are lost to follow-up (LTFU), or alive and in-care will be assessed. Cost: The cost to the health system/patient will be described based on a micro-costing analysis from available procurement and pharmacy data. Average SD in HBa1c: This statistic will determine variability in the standard deviation of HbA1C in order to inform further studies. Quality of life: WHO Quality of Life surveys will be conducted at the start and conclusion of the study period. baseline and 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Neno District Hospital Neno District Hospital Neno Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
Helmsley Charitable Trust 230 Park Ave New York 10169 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dexcom 6340 Sequence Dr san diego 92121 United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Brigham and Womens Hospital 75 Francis St. Boston 02115 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Paul Park ppark@bwh.harvard.edu +13175319310 75 Francis St.
City Postal code Country Position/Affiliation
Boston 02115 United States of America Associate scientist
Role Name Email Phone Street address
Public Enquiries Gene Bukhman Gene_Bukhman@hms.harvard.edu +16177325500 75 Francis St.
City Postal code Country Position/Affiliation
Boston 02115 United States of America Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries Alma Adler aadler2@bwh.harvard.edu +16177325500 75 Francis St.
City Postal code Country Position/Affiliation
Boston 02115 United States of America Associate researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All patient level data, analysis and results will be available for peers assuming their request is of scientific merit Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol start: upon publication end: 2 years Controlled; peers may request data and we will share assuming that the interest is of scientific merit.
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