Harmful effects of Insulin and how we can minimize them.

Adverse Effects of Insulin treatment and how to minimize them.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2018/06/014479

Enrollment

240

Registered

2018-06-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Insulin Injection associated Lipohypertrophy, Hypoglycaemia in Type 1 Diabetes Patients

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Patients of Type I DM Part I: >4 mths duration of T1DM Part II:

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Part I: Prevalence and severity of Lipohypertrophy and Hypoglycaemia at enrollment in trial. Part II: Effect of educational intervention on development of LH assessed after 15 months of Insulin use. Timepoint: Part I: at enrollment in trial. Part II: Every 3 months from date of enrollment for each patient for the intervention arm and Final assessment after 15 months of Insulin use for all participants of the trial. Actual date will vary for each participant as per the date of enrollment.	—

Measure

Time frame

Part I: Prevalence and severity of Lipohypertrophy and Hypoglycaemia at enrollment in trial. Part II: Effect of educational intervention on development of LH assessed after 15 months of Insulin use. Timepoint: Part I: at enrollment in trial. Part II: Every 3 months from date of enrollment for each patient for the intervention arm and Final assessment after 15 months of Insulin use for all participants of the trial. Actual date will vary for each participant as per the date of enrollment.

—

Secondary

Measure	Time frame
1. Identification of predisposing factors. 1. Effect of LH on dose requirement, glycaemic control Timepoint: Part I: At enrollment Part II: AT 15 months of Insulin use	—

Countries

India

Contacts

Public ContactRanjana Sahasrabudhe

Bharati Vidyapeeth (Deemed to be University), Pune

ranjanas2003@yahoo.co.in9860093752

Outcome results