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

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes
• Intervention / Treatment: Device: Pens Device; Other: Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day); Device: Syringe

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Recruiting
      • Rafael Vaz Machry
      • Contact: Rafael Vaz Machry; Phone Number: (55)5196264337

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Ticiana da Costa Rodrigues, Hospital De Clinicas De Porto Alegre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: August 3, 2015
• First Submitted That Met QC Criteria: August 4, 2015
• First Posted (Estimate): August 6, 2015

Study Record Updates

• Last Update Posted (Estimate): August 6, 2015
• Last Update Submitted That Met QC Criteria: August 4, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 13-0485