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.: PACTR201905538846394 Date of Approval: 17/05/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Implementation of home glucose meter use for insulin dependent Type 1 and 2 Diabetes patients in rural districts in Rwanda
Official scientific title Implementation of home glucose meter use for insulin dependent Type 1 and 2 Diabetes patients in rural districts in Rwanda
Brief summary describing the background and objectives of the trial To manage Type 1 and insulin dependent Type 2 diabetes successfully, patients and health care providers require a reliable, consistent method to monitor glycemic control. The current method of adjusting insulin dosages based on single random blood glucose measurement during the clinic visit, poses a hazard to patients and forces health care providers to make clinical decisions with insufficient data. Without knowledge of patients’ blood glucose levels at different intervals of the day health care providers risk increasing or decreasing insulin doses and precipitating hypoglycemic or hyperglycemic episodes in patients. Further, without knowledge of blood glucose levels, patients risk administering inappropriate doses of insulin that may precipitate severe hypoglycemia or hyperglycemia. With this implementation project, we will provide enrolled patients with the essential tools necessary for appropriate diabetes management and control, which is the international standard of at-home care. We will then monitor and evaluate the impact of the self-monitoring of blood glucose (SMBG) on glycemic control. Outlined below are the specific objectives: Aim 1 (primary): Feasibility Identify factors, perceived usefulness, facilitators and barriers, that may influence the use of SMBG, glucose meter logbook and waste disposal, use among a) Type 1 and insulin dependent type 2 diabetes patients receiving treatment at Kirehe, Rwinkwavu and Butaro district hospitals and b) health care providers providing services at the NCD clinics within these facilities. Aim 2 (Secondary): Monitor and Evaluate the early outcome of SMBG on measures of glycemic control among the type 2 diabetes patients
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Disease control monitoring
Anticipated trial start date 10/06/2019
Actual trial start date
Anticipated date of last follow up 20/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Self monitoring blood glucose once daily blood glucose check at home 6 months Subjects will be given glucose meter, strips and log book and other related supplies. Subject will check blood glucose levels at home and record values in log book. Patient will then bring log book to the clinic visit. 45
Control Group Usual care 6 months Patient will have ongoing routine follow-up every month at clinic visits 45 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a diagnosis of Type 1 or T2DM must be on insulin regimen possess the ability to read and write well enough to record blood glucose levels/ have reliable access to a guardian who can read and write ( ability to read and write will be assessed during the enrollment period by asking participants to read and record blood sugar levels during the training session) at least 18 years of age HbA1C > 7.0% must be active in clinic ( attending clinic follow ups at-least six months prior to enrollment) a diagnosis of gestational diabetes inability to read and write lack of access to a person at home who can read and write diagnosis of chronic kidney disease 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 99 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 18/02/2019 Rwanda National Ethics Comittee
Ethics Committee Address
Street address City Postal code Country
Rwanda Ministry of Health Kigali 00000 Rwanda
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 09/04/2019 Partners IRB
Ethics Committee Address
Street address City Postal code Country
800 Boylston St Boston 02199 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Feasibility - use of log manual, glucose meter, perceived usefulness and/or concerns of glucose meter use at home Before and after
Secondary Outcome Clinical improvement - HbA1c, retention to care including SMBG program, quality of life, hospitalization rates before and after
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Rwinkwavu District Hosptial Rwinkwavu district hospital Rwinkwavu Rwanda
Kirehe District Hospital Kirehe District Hospital Kirehe Rwanda
Butaro district hospital Butaro district hospital Butaro Rwanda
FUNDING SOURCES
Name of source Street address City Postal code Country
Helmsley Charitable Trust 230 Park Avenue, Suite 659 New York 10169 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Brigham and Womens Hospital 75 Francis St. Boston 02115 United States of America Hospital
Secondary Sponsor Partners In Health 800 Boylston Street, Suite 300 Boston 02115 United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Harvard Medical School 25 Shattuck St Boston 02115 United States of America
Rwanda Ministry of Health KN 3 Rd Kigali Rwanda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gene Bukhman gbukhman@bwh.harvard.edu 6175213381 75 Francis St.
City Postal code Country Position/Affiliation
Boston United States of America Brigham and Womens Hospital and Partners In Health and Harvard Medical School
Role Name Email Phone Street address
Public Enquiries Paul Park ppark@bwh.harvard.edu 6175213381 75 Francis St.
City Postal code Country Position/Affiliation
Boston 02115 United States of America Brigham and Womens Hospital and Partners In Health and Harvard Medical School
Role Name Email Phone Street address
Scientific Enquiries Paul Park ppark@bwh.harvard.edu 6175213381 75 Francis St.
City Postal code Country Position/Affiliation
Boston United States of America Brigham and Womens Hospital and Partners In Health and Harvard Medical School
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We do NOT intend to share deidentified IPD. When the summary results are available, we will provide wtihin 12 months of completion data Study Protocol N/A N/A
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