Non-specific diabetes mellitus – without complications
Conditions
Interventions
The Klivo Intervention Program (KIP), a model of behavior change based on an intensive lifestyle intervention method, seeks to manage the daily lifestyle of adults with type 2 diabetes mellitus, age o
V01.665
Sponsors
Klivo Licenciamento Ltda.
Klivo Licenciamento Ltda.
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Diagnosis of type 2 diabetes mellitus in the electronic medical record of health plans and healthcare provider organizations (HbA1c reading 7% or higher; aged between 18 and 65 years). Willingness to receive phone calls and messages for monitoring the disease and for tele-education. Willingness to use the standard monitoring devices (glucometer), synchronized with the telemonitoring system according to the study protocol throughout the 12-month study period.
Exclusion criteria
Exclusion criteria: Cognitive impairment based on a diagnosis of dementia or mild cognitive impairment reported in the medical records. Self-declared reluctance to receive phone calls or messages for disease management. Pre-existing condition: chronic kidney disease stage 5; individuals with any end-stage disease with a life prognosis of fewer than two years; or pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate glycated hemoglobin (HbA1c) values at baseline (before the intervention starts) and 3, 6, 9, and 12 months after the start of intervention. A decrease in HbA1c, measured as percentage, is expected. HbA1c will be evaluated by laboratorial exams requested by the participant's medical doctor. The Hb1Ac values will be obtained via a questionnaire answered by the participant during a phone call at 3, 6, 9, and 12 months after the intervention starts and will be compared to the Hb1Ac at baseline. An 8% decrease in HbA1c post-intervention, every three months, will be considered as a successful outcome. The goal is a minimum Hb1Ac value of 7%. When this value is reached, the goal will be to maintain this value and not to reduce it even further.;To evaluate change in time in target blood glucose range (TIR) 3, 6, 9, and 12 months after the intervention starts as compared to baseline. The number of measurements within the ideal blood glucose range is expected to increase. To evaluate this outcome, capillary glucose, in mg/mL, will be measured with a glucometer, which will be sent to the participant's home address. The glucose level will be obtained with an app downloaded in the participant's smartphone, connected to the glucometer. At least a 5% increase in TIR as compared to the month before the start of the intervention will be considered a successful outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| TTo evaluate the incidence of secondary outcomes such as retinal, renal, cardiac, and cerebrovascular complications at months 3, 6, 9, and 12 after the start of the intervention. Secondary outcomes will be considered positive if during interview at months 3, 6, 9, and 12 the participant confirms recent diagnosis of any complications related to type 2 diabetes mellitus considered in this protocol. | — |
Countries
Brazil
Contacts
Public ContactAndré Sá
Klivo Licenciamento Ltda.
Outcome results
None listed