An interventional study of Continuous glucose monitor in Type 1 Diabetes, sponsored by Foundation for Innovative New Diagnostics, Switzerland. Suspended at 1 site in Kenya. Open to participants aged 4 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Foundation for Innovative New Diagnostics, Switzerland · Not applicable, Interventional, and Diagnostic
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. 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 Kenya.
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.
For all participants the first study visit will consist of:
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.
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.
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.
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".
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 246 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Foundation for Innovative New Diagnostics, Switzerland is the lead sponsor of 61 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Recipient of care participants are eligible to be included in the Study only if all the following inclusion criteria apply:
1. People living with T1 diabetes with 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:
1. 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:
1. Healthcare provider at the study sties engaged in diabetes care provision related to the study.
Exclusion Criteria:
Participants are excluded from the Study if any of the following exclusion criteria apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm 1 is those participants randomized to use of CGM in a continuous fashion; CGM use for the duration of 9 months.
Device: Continuous glucose monitor
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.
Device: Continuous glucose monitor
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.
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.
Also known as: Freestyle Libre
Impact of continuous and intermittent CGM used on blood glucose levels in comparison to standard of care in people living with type 1 diabetes
Comparison of the magnitude of change in HbA1c levels before and after treatment in standard of care, continuous, and intermittent CGM arms
Time frame: 15 months
Impact of continuous and intermittent CGM use on the stability of blood glucose concentrations related to diabetes
Estimates of coefficient of variation (CV) for glucose concentrations with 95% confidence intervals, Time in Range, Time Below Range, and Time Above Range (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.
Time frame: 15 months
Impact of continuous and intermittent CGM use on unplanned visits to outpatient clinics and/or hospital related to diabetes complications.
Number of hospitalizations related to diabetes complications per each group, represented by means and standard deviations.
Time frame: 15 months
Acceptability and feasibility of continuous and intermittent CGM use from a healthcare provider, recipients of care & care givers perspective
Feasibility will be assessed based on Arm 1 and Arm 2 adherence to protocol in terms of CGM use.
Time frame: 15 months
Cost of continuous and intermittent CGM from a user and provider perspective
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
Time frame: 15 months
Plan to share: No
This study is suspended, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Foundation for Innovative New Diagnostics, Switzerland