Nutritional, Metabolic, Endocrine
Conditions
Interventions
Self monitoring blood glucose which is routine care
Sponsors
Dexcom
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: pregnant inability of subject or care-provider to use transmitter and applicator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| % 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. | — |
Countries
Malawi
Contacts
Public ContactGene Bukhman
Assistant Professor
Outcome results
None listed