Syringes Replacement for Insulin Application for Pens Device in a Population of Elderly Patients With Type 2 Diabetes: Multifactorial Intervention to Improve Glycemic Control

Study Overview
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Brief Summary
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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.

Official Title
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Syringes Replacement for Insulin Application for Pens Device in a Population of Elderly Patients With Type 2 Diabetes: Multifactorial Intervention to Improve Glycemic controlCONTROL

Conditions
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Diabetes

Intervention / Treatment
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* Device: Pens Device
* Device: Syringe
* Other: Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pens Device<br>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 | Device: Pens Device<br> <br> Other: Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day)<br> <br> |
| Active Comparator: Syringe<br>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 | Device: Syringe<br> <br> Other: Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated Hemoglobin | reduction compared to baseline values | reduction compared to baseline values at six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Monthly measurements are made | reduction compared to baseline values at six months | 
| adherence | Monthly measurements are made | 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 |