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

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

Sponsors

Lead Sponsor: Associazione Medici Endocrinologi

Source Associazione Medici Endocrinologi
Brief 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.

Detailed 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.

Overall Status Completed
Start Date April 11, 2016
Completion Date January 31, 2017
Primary Completion Date September 30, 2016
Study Type Observational
Primary Outcome
Measure Time Frame
basal/total ratio last six month
Secondary Outcome
Measure Time Frame
glycaemic control last six month
hypoglycemia last six month
Enrollment 1036
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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.

Gender: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Giorgio Borretta, MD Principal Investigator Associazione Medici Endocrinologi
Verification Date

March 2018

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Diabetes Mellitus, Type 1

Description: patients with type 1 diabetes

Label: Diabetes Mellitus, Type 2

Description: patients with type 2 diabetes

Acronym BASAL
Patient Data No
Study Design Info

Observational Model: Case-Only

Time Perspective: Cross-Sectional

Source: ClinicalTrials.gov