Lypo-hypertrofia Characterization in Diabetes

Status Completed

Clinical Trial Summary

Aim/hypothesis: Subcutaneous insulin absorption is one of the factors which strongly influence blood sugar control in patients with diabetes mellitus on insulin therapy. In response, a regular absorption is influenced by lipo-hypertrophy in subcutaneous tissue on injection sites. So far lipo-hypertrophy diagnosis has only been clinical since there are no imaging studies that have characterized precisely morphometry of lipo-hypertrophic tissue. Methods: In two groups of 20 type 1 diabetes patients on insulin therapy, lipo-hypertrophy is characterized and defined by clinical tapping or by ultrasound with multi frequency linear probe (6-18 Mhz). Patients are therefore advised to avoid insulin injections on those areas so defined. Patients are reevaluated 3 and 12 months later

Clinical Trial Description

An observational study has been carried out, checked with parallel arms in which type 1 diabetes patients are recruited with clinical evidence of lypo-hypertrophy in insulin injected areas. Patients attend to the Diabetes Unit of Niguarda Ca' Granda Hospital. Obese patients with a thickening fat subcutaneous tissue that could have interfered with the interpreting and analyzing of the data are left out of this first study. In the control group the investigators manage to define the lypo-hypertrophic area by tapping and body inspection. In the study group the investigators can define and mark out the area/areas with lipo-hypertrophy by ultrasound scan test. All the tested patients both the control group and the study group, are discouraged from use insulin in areas where lypo-hypertrophy is present. Patients are reassessed after 3 months with a clinical assessment of glucose control by HbA1c. After 12 months subcutaneous tissue scan is repeated in 10 patients within the experimental group and a new assessment of HbA1c is performed. Ultrasound assessment. The scan used is Esaote My Lab70 linear probe multi-frequency [6-18 Mhz) ;

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02278926
Study type	Observational
Source	Niguarda Hospital
Contact
Status	Completed
Phase	N/A
Start date	January 2012
Completion date	October 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04476472` - Omnipod Horizon™ Automated Glucose Control System Preschool Cohort	N/A
Completed	`NCT03635437` - Evaluation of Safety and Diabetes Status Upon Oral Treatment With GABA in Patients With Longstanding Type-1 Diabetes	Phase 1/Phase 2
Completed	`NCT04909580` - Decision Coaching for Youth and Parents Considering Insulin Delivery Methods for Type 1 Diabetes	N/A
Active, not recruiting	`NCT00679042` - Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol	Phase 3
Completed	`NCT03293082` - Preschool CGM Use and Glucose Variability in Type 1 Diabetes	N/A
Completed	`NCT04016662` - Automated Insulin Delivery in Elderly With Type 1 Diabetes (AIDE T1D)	Phase 4
Completed	`NCT02527265` - Afrezza Safety and Pharmacokinetics Study in Pediatric Patients	Phase 2
Completed	`NCT03738865` - G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes	Phase 3
Completed	`NCT03240432` - Wireless Innovation for Seniors With Diabetes Mellitus	N/A
Completed	`NCT03168867` - Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)	N/A
Completed	`NCT03674281` - The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System	N/A
Completed	`NCT03669770` - Ultrasound Classification and Grading of Lipohypertrophy and Its Impact on Glucose Variability in Type 1 Diabetes
Recruiting	`NCT03682640` - Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes	Phase 2
Recruiting	`NCT04096794` - Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research
Completed	`NCT02882737` - The Impact of Subcutaneous Glucagon Before, During and After Exercise a Study in Patients With Type 1 Diabetes Mellitus	N/A
Recruiting	`NCT02745808` - Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes	Phase 1
Withdrawn	`NCT02518022` - How to be Safe With Alcoholic Drinks in Diabetes	N/A
Completed	`NCT02562313` - A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®	Phase 1
Withdrawn	`NCT02579148` - Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes	Phase 1
Completed	`NCT02596204` - Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.