Stosowanie urządzeń do ciągłego monitorowania glukozy wśród osób żyjących z cukrzycą typu 1 w Kenii. (ACCEDE)

Study Design As this study is a PrCT the study aspects will be embedded in the normal clinical care delivery of diabetes care in the selected clinics. Introducing only 1 additional clinic visit and 1 additional qualitative visit for study related procedures. The primary outcome measure, HbA1c, will be assessed through the HbA1c testing that is already used in these clinics. It is important to note that the type of HbA1c test (i.e.: laboratory-based vs point-of-care) per participant must remain constant during the study, this is because of variability of performance between various HbA1c testing platforms.

General Design This is a three-arm pragmatic randomized control study. The expected duration of study participants involvement in the study is 15 months, this consists of 9 months of intervention with a follow up visit 6 months post the last interventional study visit.

• Arm 1 is those participants randomized to use of CGM in a continuous fashion; CGM use for the duration of 9 months.
• Arm 2 is those participants randomized to intermittent use of CGM; CGM use for 4 time points consisting of 2 weeks of CGM use each, for the duration of 9 months.
• Arm 3 is those participants randomized to standard of care; regular use of self-monitoring of blood glucose (SMBG) for the duration of 9 months.

For all participants the first study visit will consist of:

1. Enrolment including ICF,
2. Baseline surveys including demographics and the Glucose Monitoring Satisfaction Survey
3. randomized assignment to study arm,
4. blood draw for HbA1c testing.

For those randomized to Arm 3 the clinicians visit will take place during enrolment visit. For those randomized to Arm 1 and Arm 2 they will receive an education session on the CGM, be provided with the CGM, and be guided how to self-apply the CGM during enrolment visit.

During all Study Follow Up visits participants will have blood drawn for HbA1c testing, complete a brief survey to capture any hospitalizations and/or hypoglycaemic events related to diabetes complications that occurred between study visits. During Study Follow up visit C participants will complete HRQOL surveys.

Detailed explanation of the study visits per arm are outlined below by arm in section Qualitative methods used across all arms will consist of focus group discussions (FGDs) among the participants and caregivers of participants. Approximately 15 participants above the age of 18 years old will be selected from each arm (n=45, 3 FGD in total) and approximately 15 participants age range of 11 to 17 years old will be selected from each arm (n=45, 3 FGD in total) to participate in arm specific FGD to take place 30 to 35 weeks after study enrolment started. These FGDs will focus on understanding participant perceptions towards their current glucose monitoring devices and quality of life. To capture the perspectives of care givers of children and adolescents living with T1 diabetes 15 caregivers will be selected from each arm (n=45, 3 FGD in total) to participate in arm specific FGDs to take place 30 to 35 weeks after study enrolment started. These FGDs will focus on understanding care giver perspectives towards their charge's glucose monitoring devices and quality of life from the perspective of the care giver as well as their perceptions towards the quality of life for their charge.

Qualitative methods will also be used to gather perceptions from the healthcare providers regarding their perceptions surrounding the feasibility and acceptability of use of CGMs in their settings. This will consist of a semi-structured interviews (SSI) of selected HCW (n"10 total) to be conducted after week 36 after study enrolment started.

Arm 1 Continuous use of CGM For those in Arm 1 there will be 6 clinical study visits for all participants. There will be an additional visit for a FGD among a subset of participants.

1. Enrolment visit: For those randomized to Arm 1 they will receive an education session on the CGM, be provided with the CGM, blood will be drawn for HbA1c testing, and be guided how to self-apply the CGM during enrolment visit.
2. The second study visit will take place 1 week after the enrolment visit. During this second visit the participant will see the clinician and review the CGM data from the first week. Participants in Arm 1 will be provided with 7 additional CGMs such that they have one CGM extra CGM on hand as a spare if any issue arises with a CGM and needs to be replaced, and 6 to continually use the CGM devices until their third study visit (Study Follow up A) to take place at the end of 11 weeks after enrolment.
3. Study Follow up A: At the third study visit participants will see the clinician and review the CGM data from the period of time in between second study visit and current, blood will be drawn for HbA1c testing, and the participant will be provided with 6 additional CGMS such that the continually use the CGM devices until their fourth study visit (Study Follow up B) to take place at the end of 23 weeks after enrolment.
4. Study Follow up B: At the fourth study visit participants will see the clinician and review the CGM data from the period of time in between third study visit and current, blood will be drawn for HbA1c testing, and the participant will be provided with 6 additional CGMS such that they continually use the CGM devices until their fifth study visit (Study Follow up C) to take place at the end of 35 weeks after enrolment.
5. Study Follow up C: At the fifth study visit participants will see the clinician and review the CGM data from the period in between fourth study visit and current, blood will be drawn for HbA1c testing and the participant will be provided with 1 additional CGM to use for the week following Study follow up C.
6. Study Follow up D: At the sixth and final study visit which takes place at the end of week 57 from enrolment study participants will see the clinician and blood will be drawn for HbA1c.

Arm 2 Intermittent use of CGM For those in Arm 2 there will be 6 clinical study visits for all participants. There will be an additional visit for a FGD among a subset of participants.

1. Enrolment visit: For those randomized to Arm 2 they will receive an education session on the CGM, be provided with the CGM, blood will be drawn for HbA1c testing, and be guided how to self-apply the CGM during enrolment visit.
2. The second study visit will take place 1 week after the enrolment visit. During this second visit the participant will see the clinician and review the CGM data from the first week. Participants in Arm 2 will be provided with 2 additional CGMs, one CGM to have on hand as a spare if any issue arises with a CGM and needs to be replaced and 1 such that they use 1 CGM for the week directly following the clinician visit and 1 week before their third study visit (Study Follow up A) to take place at the end of 11 weeks after enrolment.
3. Study Follow up A: At the third study visit participants will see the clinician and review the CGM data from the preceding week before Study follow up A, blood will be drawn for HbA1c testing, and the participant will be provided with 1 additional CGM such that the participant uses the CGM for the week directly following Study follow up A and 1 week before their fourth study visit (Study Follow up B) to take place at the end of 23 weeks after enrolment.
4. Study Follow up B: At the fourth study visit participants will see the clinician and review the CGM data from the preceding week before Study follow up B, blood will be drawn for HbA1c testing, and the participant will be provided with 1 additional CGM such that the participant uses the CGM for the week directly following Study follow up A, and 1 week before their fifth study visit (Study Follow up C) to take place at the end of 35 weeks after enrolment.
5. Study Follow up C: At the fifth study visit participants will see the clinician and review the CGM data from the week preceding Study Follow up C, blood will be drawn for HbA1c testing and the participant will be provided with 1 additional CGM to use for the week following Study follow up C.
6. Study Follow up D: At the sixth and final study visit which takes place at the end of week 57 from enrolment study participants will see the clinicals and blood will be drawn for HbA1c.

Arm 3 Standard of Care For those in Arm 3 there will be 5 clinical study visits for all participants. There will be an additional visit for a FGD among a subset of participants. Participants will follow the standard of care at each clinic.

1. Enrolment visit: Those participants randomized to Arm 3 will see their clinician at the enrolment visit as per SoC. Blood will be drawn for HbA1c testing.
2. Study Follow up A: the second study visit will take place at the end of 11 weeks after enrolment, participants will see the clinician as per SoC. Blood will be drawn for HbA1c testing.
3. Study Follow up B: the third study visit will take place at the end of 23 weeks after enrolment. participants will see the clinician as per SoC. Blood will be drawn for HbA1c testing.
4. Study Follow up C: the fourth study visit will take place at the end of 35 weeks after enrolment. Participants will see the clinician as per SoC. Blood will be drawn for HbA1c.
5. Study Follow up D: the fifth and final study visit will take place at the end of 57 weeks after enrolment. participants will see the clinician as per SoC. Blood will be drawn for HbA1c.

Scientific Rationale for Study Design As this study intendeds to generate evidence to inform policy and decision makers on the potential benefits of use of CGM in Kenya a pragmatic, rather than an explanatory, randomized control study design was selected. A PrCT design was selected as the study aims to understand the impact of CGM use in as close to real world settings as possible. A classically designed randomized control trial with overly strict study criteria and processes may lead results that are not directly translatable to real world experience, while a classical RCT may have strong internal validity often RCTs are criticized for a lack of external validity, therefore a PrCT design was selected to balance internal and external validity. A PrCT design may "provide more realistic effect size estimates and enhance translation of research findings into clinical practice".