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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] 289854 0
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 299794 0
Condition category
Condition code
Metabolic and Endocrine 299723 299723 0 0
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] 295538 0
Behaviour
Intervention code [2] 295684 0
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] 299183 0
the changes of HbA1c from baseline to the end of study in both groups
with structured education and control group
Timepoint [1] 299183 0
6 months after first visit
Primary outcome [2] 299363 0
proportion of patients reaching individualized target of HbA1c (established a priori by the physician) in each group (with / without enhanced education)
Timepoint [2] 299363 0
6 months after the first visit
Secondary outcome [1] 326444 0
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] 326444 0
6 months after enrollment
Secondary outcome [2] 326938 0
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] 326938 0
6 months after enrollment
Secondary outcome [3] 326939 0
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] 326939 0
6 months after enrollment
Secondary outcome [4] 326940 0
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] 326940 0
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?
No
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] 8078 0
Romania
State/province [1] 8078 0

Funding & Sponsors
Funding source category [1] 294232 0
Commercial sector/Industry
Name [1] 294232 0
Sanofi
Country [1] 294232 0
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] 293061 0
None
Name [1] 293061 0
Address [1] 293061 0
Country [1] 293061 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295652 0
Romanian National Ethic Committee
Ethics committee address [1] 295652 0
Ethics committee country [1] 295652 0
Romania
Date submitted for ethics approval [1] 295652 0
Approval date [1] 295652 0
01/10/2014
Ethics approval number [1] 295652 0

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 68030 0
Dr Cornelia Bala
Address 68030 0
Iuliu Hatieganu University of Medicine and Pharmacy Department of Diabetes, Nutrition, Metabolic Diseases 2 Clinicilor St, 400 006 Cluj-Napoca,
Country 68030 0
Romania
Phone 68030 0
+40722605501
Fax 68030 0
Email 68030 0
[email protected]
Contact person for public queries
Name 68031 0
Dr Cornelia Bala
Address 68031 0
Iuliu Hatieganu University of Medicine and Pharmacy Department of Diabetes, Nutrition, Metabolic Diseases 2 Clinicilor St, 400 006 Cluj-Napoca,
Country 68031 0
Romania
Phone 68031 0
+40722605501
Fax 68031 0
Email 68031 0
[email protected]
Contact person for scientific queries
Name 68032 0
Dr Cornelia Bala
Address 68032 0
Iuliu Hatieganu University of Medicine and Pharmacy Department of Diabetes, Nutrition, Metabolic Diseases 2 Clinicilor St, 400 006 Cluj-Napoca,
Country 68032 0
Romania
Phone 68032 0
+40722605501
Fax 68032 0
Email 68032 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseThe 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.2019https://dx.doi.org/10.2478/rjdnmd-2019-0020
N.B. These documents automatically identified may not have been verified by the study sponsor.