NCT03489031

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,036

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
Last Updated

April 5, 2018

Status Verified

March 1, 2018

Enrollment Period

6 months

First QC Date

March 20, 2018

Last Update Submit

March 29, 2018

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • glycaemic control

    last six month

  • hypoglycemia

    last six month

Study Arms (2)

Diabetes Mellitus, Type 1

patients with type 1 diabetes

Diabetes Mellitus, Type 2

patients with type 2 diabetes

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All diabetic patients respecting eligibility criteria

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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(7):625-9. doi: 10.1002/(SICI)1096-9136(199607)13:73.0.CO;2-2.

    PMID: 8840095RESULT

  • Laubner K, Molz K, Kerner W, Karges W, Lang W, Dapp A, Schutt 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 multicenter analysis of 51 964 patients from the German/Austrian DPV-wiss database. Diabetes Metab Res Rev. 2014 Jul;30(5):395-404. doi: 10.1002/dmrr.2500.

    PMID: 24302583RESULT

  • 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 2012 Sep 9.

    PMID: 22882249RESULT

  • Castellano E, Attanasio R, Giagulli VA, Boriano A, Terzolo M, Papini E, Guastamacchia E, Monti S, Aglialoro A, Agrimi D, Ansaldi E, Babini AC, Blatto A, Brancato D, Casile C, Cassibba S, Crescenti C, De Feo ML, Del Prete A, Disoteo O, Ermetici F, Fiore V, Fusco A, Gioia D, Grassi A, Gullo D, Lo Pomo F, Miceli A, Nizzoli M, Pellegrino M, Pirali B, Santini C, Settembrini S, Tortato E, Triggiani V, Vacirca A, Borretta G; all on behalf of Associazione Medici Endocrinologi (AME). The basal to total insulin ratio in outpatients with diabetes on basal-bolus regimen. J Diabetes Metab Disord. 2018 Oct 1;17(2):393-399. doi: 10.1007/s40200-018-0358-2. eCollection 2018 Dec.

    PMID: 30918874DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Giorgio Borretta, MD

    Associazione Medici Endocrinologi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2018

First Posted

April 5, 2018

Study Start

April 11, 2016

Primary Completion

September 30, 2016

Study Completion

January 31, 2017

Last Updated

April 5, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share