Nutritional, Metabolic, Endocrine
Conditions
Sponsors
Foundation for Innovative New Diagnostics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Recipient of care participants are eligible to be included in the Study only if all the following inclusion criteria apply: • People living with T1 diabetes with HbA1c 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: • 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: • Healthcare provider at the study sties engaged in diabetes care provision related to the study.
Exclusion criteria
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 18 months prior to enrollment • People living with type 2 diabetes. • Known pregnancy at the time of study enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the magnitude of change in HbA1c levels before and after treatment in standard of care, continuous, and intermittent CGM arms (i.e. mean difference in HBA1c levels with their standard deviations, F statistics, p-values) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 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. 2. Number of hospitalizations related to diabetes complications per each group, represented by means and standard deviations. 3. Mixed methods 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 4. 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. 5. 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. | — |
Countries
Kenya
Contacts
Public ContactBeatrice Vetter
Director Noncommunicable Diseases
Outcome results
None listed