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Trial registered on ANZCTR

Registration number

ACTRN12616001273471

Ethics application status

Approved

Date submitted

5/08/2016

Date registered

9/09/2016

Date last updated

9/09/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

The impact of a structured diabetes education program for improving glycemic control in adults with type 2 diabetes

Scientific title

The assessment of the impact of a structured diabetes education program on glycaemic control in adult type 2 diabetes patients at initiation of basal insulin analogue

Secondary ID [1]

Identifiers assigned by the sponsor: DIREGL07301

Universal Trial Number (UTN)

Trial acronym

Basal-EDUC-RO

Linked study record

Health condition

Health condition(s) or problem(s) studied:

type 2 diabetes mellitus

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

In enhanced educational group
- Curriculum Modules 1: information about the importance of glycaemic control, diabetes complications video, reinforce the need of life style changes, how insulin works, training about device, glucometers and self monitoring blood glucose (SMBG), hypoglycaemia and titration+ brochure - guideline for patients realized by Romanian Association od Education in Diabetes - 45 minutes, provided by a trained nurse, in the first week after first visit, in physician office, one-on-one discussion
- Curriculum Modules 2: a short interview with patients about his/her knowledge and changes that he/her has done in the past 3 months; reinforce the information which was not very well understood, check SMBG diary and insulin titration algorithm; education about insulin treatment complication and the possibility of intensification need (how to check postprandial glycaemia) - 45 minutes, provided by a trained nurse in the first week after visit 2, in physician office, one-on-one discussion

All enrolled patients have performed 3 medical visits( first - baseline, at initiation, second - after 3 months, third - after 6 months); the data has been collected by the Investigators in the Case Report Forms (CRFs) and, on visits 1 and 3, the patients filled-in “EQ5D” and “Diabetes Empowerment Scale (DES”) questionnaires.
Not specific strategies used to monitor adherence

Intervention code [1]

Behaviour

Intervention code [2]

Lifestyle

Comparator / control treatment

Usually daily practice education that means a short training about device, glucometers used, injection technique and hypoglycaemia done by the nurse or physician - in control group - one to one 15 minutes session or 30 minutes group sessions
Both groups receive the same treatment - with basal insulin + OADs at investigator decision.

Control group

Active

Outcomes

Primary outcome [1]

the changes of HbA1c from baseline to the end of study in both groups
with structured education and control group

Timepoint [1]

6 months after first visit

Primary outcome [2]

proportion of patients reaching individualized target of HbA1c (established a priori by the physician) in each group (with / without enhanced education)

Timepoint [2]

6 months after the first visit

Secondary outcome [1]

the incidence of confirmed symptomatic (<70 mg/dl) hypoglycemic episodes at the end of study for both groups - in number of events - measured by SMBG

Timepoint [1]

6 months after enrollment

Secondary outcome [2]

the incidence of confirmed symptomatic (<70 mg/dl) hypoglycemic episodes at the end of study for both groups - in number of patients that experienced at least one hypoglycemic events - measured by SMBG

Timepoint [2]

6 months after enrollment

Secondary outcome [3]

the incidence of severe hypoglycemic episodes (required third assistance) at the end of study for both groups in number of events - from patients interview or documented if was necessary the hospitalization

Timepoint [3]

6 months after enrollment

Secondary outcome [4]

the incidence of severe hypoglycemic episodes (that required third assistance) at the end of study for both groups - in number of patients that experienced at least one hypoglycemic events - from patients interview or documented if was necessary the hospitalization

Timepoint [4]

6 months after enrollment

Eligibility

Key inclusion criteria

1. adults diagnosed with T2 DM
2. patients treated with stable doses of oral antidiabetics drugs (OADs) ( the dose was not modified in the last 3 months)
3. the diabetes is inadequately controlled with OADs and at investigator decision the patient is initiated on basal insulin analogues
4. the determination of HbA1c value must be available at the moment of the initiation of basal insulin analogues (determined in the last month)
5. Informed Consent Form signed

Minimum age

18 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

The patient
1.was pregnant or breast-feeding or intented to be pregnant during the study
2.was treated with any systemic corticosteroid
3.was already included in other studies
4.had any contraindication to insulin treatment
5.patients not able to comply with - visit schedule

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

22/10/2014

Date of last participant enrolment

Anticipated

Actual

16/02/2015

Date of last data collection

Anticipated

Actual

17/08/2015

Sample size

Target

750

Accrual to date

Final

746

Recruitment outside Australia

Country [1]

Romania

State/province [1]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Sanofi

Address [1]

Sanofi Romania, str Gara Herastrau nr 4, floor 8, Bucharest Romania, postcode 020334

Country [1]

Romania

Primary sponsor type

Commercial sector/Industry

Name

sanofi Romania

Address

Sanofi Romania, str Gara Herastrau nr 4, floor 8, Bucharest Romania, postcode 020334

Country

Romania

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Romanian National Ethic Committee

Ethics committee address [1]

Ethics committee country [1]

Romania

Date submitted for ethics approval [1]

Approval date [1]

01/10/2014

Ethics approval number [1]

Summary

Brief summary

There are no data in Romania (and not so many worldwide) explaining why some patients fail to achieve good glycemic control during insulin therapy. Hypothetically, such failure could be the fault of the healthcare professionals (e.g. insufficient advice) or of the patients (e.g. poor adherence, fear of hypoglycemia). Starting from these observations, we had intended to assess effectiveness of enhanced education delivered by trained diabetes educators / nurses on the improvement of diabetes management.
This disease registry evaluated the efficacy of enhanced education of patients with T2DM at the time of starting on basal insulin regimen.  We estimated that we would detect a significant difference in mean value of HbA1c in-between both arms (patients with enhanced or standard education) at the end of 6 months observation period but not less than 0.3%. between the groups.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Cornelia Bala

Address

Iuliu Hatieganu University of Medicine and Pharmacy Department of Diabetes, Nutrition, Metabolic Diseases 2 Clinicilor St, 400 006 Cluj-Napoca,

Country

Romania

Phone

+40722605501

Fax

cbala@umfcluj.ro

Contact person for public queries

Name

Cornelia Bala

Address

Iuliu Hatieganu University of Medicine and Pharmacy Department of Diabetes, Nutrition, Metabolic Diseases 2 Clinicilor St, 400 006 Cluj-Napoca,

Country

Romania

Phone

+40722605501

Fax

cbala@umfcluj.ro

Contact person for scientific queries

Name

Cornelia Bala

Address

Iuliu Hatieganu University of Medicine and Pharmacy Department of Diabetes, Nutrition, Metabolic Diseases 2 Clinicilor St, 400 006 Cluj-Napoca,

Country

Romania

Phone

+40722605501

Fax

cbala@umfcluj.ro

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The Impact of Structured Diabetes Education on Glycemic Control in Patients with Type 2 Diabetes at Initiation of Basal Insulin-The Basal-EDUC-RO Study: A Randomized Prospective Study.	2019	https://dx.doi.org/10.2478/rjdnmd-2019-0020

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically