Effect of patient education on insulin use and glycemic control in Type I Diabetes Mellitus and the challenges in management.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/09/009679
• Date of registration: 07-09-2017
• Prospective Registration: No
• Primary sponsor: Dr Dhiraj R S
• Public title: Effect of patient education on insulin use and glycemic control in Type I Diabetes Mellitus and the challenges in management.
• Scientific title: Effect of systematic patient education on insulin use and glycemic control in type 1 diabetes mellitus and the challenges in management - a mixed methods study
• Date of first enrolment: 01-04-2015
• Target sample size: 50
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=11535
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label
• Phase: Phase 2

Countries of recruitment

India

Contacts

• Name: Dr Denis Xavier
• Affiliation: St Johns Medical College

• Name: Dr Dhiraj R S
• Affiliation: St Johns Medical College

Key inclusion & exclusion criteria

Inclusion criteria: Patients above 8 years of age with type 1 diabetes diagnosed for at least 1 year
Exclusion criteria: Patients on continuous glucose monitoring

Patients in whom 6 month follow up is not posible

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Stable Health Condition 2: E108- Type 1 diabetes mellitus with unspecified complications

Intervention(s)

Intervention1: Education: Systematic education to the patient and care-giver by one on one interaction or through telephone along with the help of modules designed for a period of 5 months
Control Intervention1: Standard care: The usual standard physician care to the patient.

Primary Outcome(s)

Mean number of hypoglycemic episodes at 1 month and 6 monthsTimepoint: 1 month and 6 months

Secondary Outcome(s)

Reduction in HbA1CTimepoint: 6 months

Secondary ID(s)

NIL

Source(s) of Monetary Support

Dr.Dhiraj R S, Department of Pharmacology, St.Johns Medical College, Bangalore - 560034

Division of Clinical Research and Training, St.Johns Research Institute, St.Johns National Academy of Health Sciences, Koramangala, Bangalore - 560034

Ethics review

Status: Approved
Approval date: 08/05/2015
Contact:

ST.JOHNS NATIONAL ACADEMY OF HEALTH SCIENCES

Results

• Date Completed: 30/04/2017