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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pens Device | Experimental | All patients will receive pens device, insulin, blood glucose monitor, lancet tapes, capillary blood glucose tests (3 tests/day). All will be evaluated monthly for six months |
|
| Syringe | Active Comparator | All patients will receive syringe to insulin, insulin, blood glucose monitor, lancet tapes, capillary blood glucose tests (3 tests/day). All will be evaluated monthly for six months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pens Device | Device |
| ||
| Syringe |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated Hemoglobin | reduction compared to baseline values | reduction compared to baseline values at six months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Monthly measurements are made | reduction compared to baseline values at six months |
| adherence | Monthly measurements are made |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rafael Vaz Machry | Contact | (55)05196264337 | rafael.machry@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ticiana da Costa Rodrigues | Hospital de ClÃnicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rafael Vaz Machry | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34118981 | Derived | Machry RV, Cipriani GF, Pedroso HU, Nunes RR, Pires TLS, Ferreira R, Vescovi B, de Moura GP, Rodrigues TC. Pens versus syringes to deliver insulin among elderly patients with type 2 diabetes: a randomized controlled clinical trial. Diabetol Metab Syndr. 2021 Jun 12;13(1):64. doi: 10.1186/s13098-021-00675-y. |
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|
| Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day) | Other |
|
| reduction compared to baseline values at six months |
| Number of pills, antidiabetics drugs and antihypertensives drugs | Monthly measurements are made | reduction compared to baseline values at six months |
| Number of hypoglycemias | Monthly measurements are made | reduction compared to baseline values at six months |
| Presence of severe hypoglycemias | Monthly measurements are made | reduction of the number of patients with this outcome compared to baseline values at six months |
| Presence of nocturnal hypoglycemias | Monthly measurements are made | reduction of the number of patients with this outcome compared to baseline values at six months |
| Presence of asyntomatic hypoglycemias | Monthly measurements are made | reduction of the number of patients with this outcome compared to baseline values at six months |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013594 | Syringes |
| D001786 | Blood Glucose |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D005947 | Glucose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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