Basal Insulin And Compensation Glycemic In Diabetic Patients In Basal Bolus Outpatient. (BASAL)

March 29, 2018 updated by: Associazione Medici Endocrinologi

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1036

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All diabetic patients respecting eligibility criteria

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Diabetes Mellitus, Type 1
patients with type 1 diabetes
Diabetes Mellitus, Type 2
patients with type 2 diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
basal/total ratio
Time Frame: last six month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
glycaemic control
Time Frame: last six month
relationship between b/T ratio and HbA1c
last six month
hypoglycemia
Time Frame: last six month
relationship between b/T ratio and episodes of hypoglycemia
last six month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Associazione Medici Endocrinologi

Investigators

  • Principal Investigator: Giorgio Borretta, MD, Associazione Medici Endocrinologi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2016

Primary Completion (Actual)

September 30, 2016

Study Completion (Actual)

January 31, 2017

Study Registration Dates

First Submitted

March 20, 2018

First Submitted That Met QC Criteria

March 29, 2018

First Posted (Actual)

April 5, 2018

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

March 29, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASAL Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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