Basal Insulin And Compensation Glycemic In Diabetic Patients In Basal Bolus Outpatient.

Diabetes Mellitus, Type 2 Clinical Trial

— BASAL  

Official title:

Basal Study - Observational Multicentric Clinical Study: Basal Insulin And Compensation Glycemic In Diabetic Patients In Basal Bolus Outpatient.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03489031
• Other study ID #: BASAL Study
• Status: Completed
• First received: March 20, 2018
• Last updated: March 29, 2018
• Start date: April 11, 2016
• Est. completion date: January 31, 2017

Study information

• Verified date: March 2018
• Source: Associazione Medici Endocrinologi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Multicentric, observational, cross-sectional study in Italy. The aims are to evaluate the basal/total ratio of daily insulin dose (b/T) in diabetic outpatients type 1 (T1) and type 2 (T2) on basal-bolus regimen, by investigating whether there is a relationship with HbA1c and episodes of hypoglycemia.

Description:

The study was commissioned by the Italian Association of Clinical Endocrinologists (Associazione Medici Endocrinologi - AME) and approved by the Ethical Committee of Cuneo Hospital (BASAL Study— OSS 001/2016 - rif ENDO 30). The research was open to all specialists taking care of patients with diabetes in Italy.

The primary endpoint was glycemic control, evaluated by HbA1c levels, according to b/T.

Secondary endpoints were occurrence of major hypoglycemic episodes according to b/T; differences between patients with T1 and T2.

An ad hoc form was developed and used to record all medical findings. The form was emailed to all participating centers who then emailed or faxed it back to our data manager. Data were checked for accuracy.

The following data were required: age, gender, body weight and height, country of origin, type of diabetes and its duration, units of basal and total (basal plus prandial) daily insulin, type of basal insulin (Glargine, Detemir or Degludec), use and dosage of metformin, and number of major hypoglycemic episodes (<40 mg/dL or requiring caregivers intervention) in the last three months. Serum creatinine and HbA1c levels obtained within the previous two months were also required.

Each participating center recruited between 20 and 40 diabetic outpatients. Inclusion criteria were as follows: adult outpatients (≥20 and ≤80 years) with T1 or T2 diabetes mellitus, on basal-bolus insulin regimen (basal insulin, i.e. Glargine, Detemir or Degludec, plus at least two prandial insulin shots) for at least six months, usually assuming three daily meals, and capable of informed consent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1036
• Est. completion date: January 31, 2017
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• adult outpatients (=20 and =80 years);

• T1 or T2 diabetes mellitus;

• basal-bolus insulin regimen (basal insulin, i.e. Glargine, Detemir or Degludec, plus at least two prandial insulin shots) for at least six months;

• assuming three daily meals;

• capable of informed consent.

Exclusion Criteria:

• pregnancy;

• breast-feeding;

• severe liver or renal failure (eGFR <30 mL/min/1.73 m2);

• use of OADs (except for metformin);

• hospitalization for any cause in the last six month;

• glucocorticoid treatment in the last six month;

• oncologic treatment in the last six month;

• Ramadan in the last six months.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Associazione Medici Endocrinologi

References & Publications (3)

Heinemann L, Heise T, Wahl LC, Trautmann ME, Ampudia J, Starke AA, Berger M. Prandial glycaemia after a carbohydrate-rich meal in type I diabetic patients: using the rapid acting insulin analogue [Lys(B28), Pro(B29)] human insulin. Diabet Med. 1996 Jul;13 — View Citation

Laubner K, Molz K, Kerner W, Karges W, Lang W, Dapp A, Schütt M, Best F, Seufert J, Holl RW. Daily insulin doses and injection frequencies of neutral protamine hagedorn (NPH) insulin, insulin detemir and insulin glargine in type 1 and type 2 diabetes: a m — View Citation

Nosek L, Roggen K, Heinemann L, Gottschalk C, Kaiser M, Arnolds S, Heise T. Insulin aspart has a shorter duration of action than human insulin over a wide dose-range. Diabetes Obes Metab. 2013 Jan;15(1):77-83. doi: 10.1111/j.1463-1326.2012.01677.x. Epub 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	basal/total ratio	To evaluate the basal/total ratio of daily insulin dose (b/T) in diabetic outpatients type 1 (T1) and type 2 (T2) on basal-bolus regimen	last six month
Secondary	glycaemic control	relationship between b/T ratio and HbA1c	last six month
Secondary	hypoglycemia	relationship between b/T ratio and episodes of hypoglycemia	last six month

External Links

•   italian standard for treatment of diabetic patients