LH Project

Descrizione

Location: Italy

Project: Hypoglycemia and costs for diabetologies

Year: 2018 – Duration: 3 months

Category: Diabetology and Nephrology

OBSERVATION STUDY IN REAL LIFE ON THE FREQUENCY OF CUTANEOUS INJECTION LIPODYSTROPHIES IN PEOPLE INSULIN WITH DIABETES MELLITUS AND / OR ADVANCED KIDNEY DISEASE AND DIALYSIS (OSDIAB-1)

Hypoglycemia (HYPO) is the event most feared by insulin-treated diabetics and in many cases is responsible of a poor quality of life, poor glycemic control, self-reduction of therapy.
Little addressed is the increase in direct costs (emergency referrals, calls to 118, lost work days, etc.) and long-term complications (more visits and specialized medicines, hospitalization and disability) deriving from frequent episodes of HYPO. In turn, Hypos depend on incorrect insulin dosage, unplanned physical activity and / or gastro-intestinal disorders. A little investigated cause of HPOs is the incorrect injection technique to which diabetes  teams pay little attention. The use of too long needles, the missed injection sites rotation, the re-use of the same needle several times cause localized subcutaneous lipo-hypertrophy (LH). In addition, insulin injection into LH correlates closely with wide glycemic variability and frequent unexplained hypoglycemia,
all causes of cardio-vascular events and micro-vascular complications.

Purpose of the project

The purpose of this multi-year Research Project is to demonstrate how a simple and quick check of the injection sites, and a subsequent educative  recall on how to correctly inject insulin can:

– reduce the frequency and severity of hypoglycemia

– minimize recourse to emergency services / hospitalization

– promote the reduction of insulin doses

– reduce direct costs

– improve the quality of life of diabetics

01.Expected results

1. reduction of the HYPOs
2. improvement of quality of life
3. cost reduction

02.Instruments

1. observation and palpation of the injection areas
2. grid to compare and recognize lipodistrophy (according to
3. educational kit, Beckton and Dickinson)
4. electronic record of presence / absence of HYPOs before and after the educational session and follow-up every six months, including the recording of insulin doses
5. estimate of costs according to national expenditure indicators

03.Population under study

The is addressed to two subject’s series, both with insulin multi-injective treatment:
1. people with type 2 and type 1 diabetes mellitus
2. diabetic subjects with end-stage chronic kidney disease and dialysis

Appendix 1

This patient marked injection sites with small patches (panel a): instead of using the entire surface of the abdomen he always injected the insulin into the same identical locations marked by the patches, causing lipohypertrophy to occur (panels b and c).

Some examples of bruising at injection sites: panel a: upper part of the arm; panel b: injections too close to one another within the same site (lateral part of the arm); panel c: ecchymosis close to the inguinal fold.

Roundish lipo-hypertrophy swelling at the root of the thigh.

Large lipo-hypertrophy nodules of the distal arm (panel a) and proximal forearm (panel b), with associated signs of exceeding pen pressure applied to the skin.

Schematic representation and morphological features and the identification features of four major types of lipodystrophy.

Ultrasound scans of an abdominal LH nodule. Fibrous striae are easily seen within the subcutaneous adipose tissue in all three figure panels. In the first and third ones, however nodule borders are linear and sharp while in the second panel rounded borders are seen (narrower peripherally than in the center).

Appendix 2

The costs were calculated by using institutional and government sources as follows:

• physician home visit €25,82 [9],

• emergency room (ER) visit and treatment €241,00 [10],

• emergency medical services (EMS) call €128.50 per hour [11],

• value of a patient’s or family member’s work day €78.60 [12],

• value of a caregiver’s work day €78.60 [13].

• Hospitalization cost, €5.025, was calculated as the average length of stay (6.7 days) multiplied by the average cost of 1 day in hospital (€750) [14].

[9] Council of Italian General Practitioners. http://www1.ordinemediciroma.it/elenco-completo/regolamenti/53-tariffaminima-nazionale-degli-onorari.html

[10] http://www.mattoni.salute.gov.it/mattoni/documenti/11_Valutazione_costi_dell_emergenza.pdf [Accessed 7 January 2018].

[11]  http://www.sanita24.ilsole24ore.com/art/regioni-e-aziende/2015-02-12/emergenza-fiaso-ecco-costi-113448.php?uuidZAbcvOTBL&refresh_ceZ1  [Accessed 7 Januaryil 2018]

[12] http://www.istat.it/it/archivio/75111 [Accessed 7 Januaryil 2018].

[13] http://demo.istat.it/ricostruzione2013/ [Accessed 7 Januaryil 2018].

[14] http://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?menuZnotizie&pZdalministero&idZ1411 [Accessed 7 July 2018].