NCT02517242

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Last Updated

August 6, 2015

Status Verified

August 1, 2015

Enrollment Period

1.3 years

First QC Date

August 3, 2015

Last Update Submit

August 4, 2015

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Glycated Hemoglobin

    reduction compared to baseline values

    reduction compared to baseline values at six months

Secondary Outcomes (7)

  • Blood Pressure

    reduction compared to baseline values at six months

  • adherence

    reduction compared to baseline values at six months

  • Number of pills, antidiabetics drugs and antihypertensives drugs

    reduction compared to baseline values at six months

  • Number of hypoglycemias

    reduction compared to baseline values at six months

  • Presence of severe hypoglycemias

    reduction of the number of patients with this outcome compared to baseline values at six months

  • +2 more secondary outcomes

Study Arms (2)

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

Device: Pens DeviceOther: Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day)

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

Device: SyringeOther: Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day)

Interventions

Pens DeviceDEVICE
Pens Device
SyringeDEVICE
Syringe
Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day)OTHER
Pens DeviceSyringe

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Glomerular Filtration Rate lower than 30
  • Considering unfit for self administration of insulin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rafael Vaz Machry

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34118981DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

SyringesBlood Glucose

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Equipment and SuppliesGlucoseHexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Ticiana da Costa Rodrigues

    Hospital de ClĂ­nicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafael Vaz Machry

CONTACT

(55)05196264337rafael.machry@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 6, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2016

Last Updated

August 6, 2015

Record last verified: 2015-08

Locations

BR(1)