Diabetes
Conditions
Brief summary
This is a prospective, intervention, randomized, phase IV study. Patients will be included with 60 years or older, both sexes, with HbA1c \>8.5% using oral antidiabetics agents and insulin and then we will be randomized by use syringe or pens device to use insulin NPH and regular. All patients will receive a blood glucose monitor, lancet tapes, capillary blood glucose tests (3 tests/day). HbA1c will be measured at baseline, 3 and 6 months. Patients will see monthly.
Interventions
DEVICEPens Device
DEVICESyringe
OTHERMonitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day)
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sixty years or older * Diabetes type 2 with Glycated Hemoglobin higher than 8.5% * Using or necessity to use insulin * Using syringe to insulin * Using at least one oral antidiabetic * Accept to participate
Exclusion criteria
* Glomerular Filtration Rate lower than 30 * Considering unfit for self administration of insulin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycated Hemoglobin | reduction compared to baseline values at six months | reduction compared to baseline values |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | reduction compared to baseline values at six months | Monthly measurements are made |
| adherence | reduction compared to baseline values at six months | Monthly measurements are made |
| Number of pills, antidiabetics drugs and antihypertensives drugs | reduction compared to baseline values at six months | Monthly measurements are made |
| Number of hypoglycemias | reduction compared to baseline values at six months | Monthly measurements are made |
| Presence of severe hypoglycemias | reduction of the number of patients with this outcome compared to baseline values at six months | Monthly measurements are made |
| Presence of nocturnal hypoglycemias | reduction of the number of patients with this outcome compared to baseline values at six months | Monthly measurements are made |
| Presence of asyntomatic hypoglycemias | reduction of the number of patients with this outcome compared to baseline values at six months | Monthly measurements are made |
Countries
Brazil
Contacts
Primary ContactRafael Vaz Machry
Outcome results
None listed