Diabetes Mellitus, Type 1BASALNCT03489031
Basal Insulin And Compensation Glycemic In Diabetic Patients In Basal Bolus Outpatient.
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Associazione Medici Endocrinologi.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- How many people
- 1,036 participants
- Where
- No sites listed yet
- Study dates
- 11 Apr 2016to 31 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All diabetic patients respecting eligibility criteria
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Mellitus, Type 1 | patients with type 1 diabetes | |
| Diabetes Mellitus, Type 2 | patients with type 2 diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: last six month
Secondary outcomes (2)
glycaemic control
relationship between b/T ratio and HbA1c
Measured: last six month
hypoglycemia
relationship between b/T ratio and episodes of hypoglycemia
Measured: last six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start11 Apr 2016
- Primary completion30 Sep 2016
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,036 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associazione Medici Endocrinologi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giorgio Borretta, MD, Principal investigator, Associazione Medici Endocrinologi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489031
- Sponsor's protocol ID
- BASAL Study
- Acronym
- BASAL
- Status last verified
- Mar 2018
- First submitted
- 20 Mar 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8840095Laubner 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.
PubMed 24302583Nosek 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.
PubMed 22882249Castellano 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.
PubMed 30918874
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basal Study - Observational Multicentric Clinical Study: Basal Insulin And Compensation Glycemic In Diabetic Patients In Basal Bolus Outpatient.
- ClinicalTrials.gov ID
- NCT03489031
- Acronym / sponsor ID
- BASAL / BASAL Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,036 participants (actual)
- Lead sponsor
- Associazione Medici EndocrinologiUniversity, hospital or other
- Study start
- 11 Apr 2016 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Mellitus, Type 1 | – | –patients with type 1 diabetes |
| Diabetes Mellitus, Type 2 | – | –patients with type 2 diabetes |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All diabetic patients respecting eligibility criteria
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
glycaemic control
Time frame: last six month
hypoglycemia
Time frame: last six month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Results publication: PubMed 8840095Heinemann 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.
- Results publication: PubMed 24302583Laubner 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.
- Results publication: PubMed 22882249Nosek 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.
- Derived from this study: PubMed 30918874Castellano 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.
- italian standard for treatment of diabetic patientsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giorgio Borretta, MD principal investigator
Associazione Medici Endocrinologi
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Associazione Medici Endocrinologi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
basal/total ratio (time frame: last six month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03489031, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.