Diabetes Mellitus 2 TypeNCT01627509
Comparison of Two Insulin Regimens in Optimally-controlled Patients With DM2.
An observational study of Diabetes Mellitus 2 Type, run by Sheba Medical Center at 2 sites in Israel.
Trial summary
Intensive Insulin Therapy (IIT) may be given in Type 2 Diabetes (T2DM) in two different ways : as Basal/bolus therapy (B/B) in four-five injections per day . as Modern Premixed Insulins( MPI's) three times per day . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus 2 Type
- How many people
- 40 participants
- Where
- 2 sitesIsrael
- Study dates
- May 2012to Aug 2013
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 40 Subjects with 1 year and more of T2DM history , with two consistent HbA1C values of 7% or less - according to the blood tests within last six months.
Major Inclusion Criteria:
- Diabetes Mellitus Type 2 diagnosis confirmed by endocrinologist.
- Diabetes Mellitus Type 2 history of one year at least.
- HAb1C < 7% and less
- Age 18-80 yrs
- Normal Liver function tests
Major Exclusion Criteria:
- History of substance use
- Pregnancy or breastfeeding mothers
- Abnormal liver or kidney functional tests
- Type 1 Diabetes or LADA
- any active disease ( like viral) at the period of investigation
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Not yet recruiting
The Institute of Endocrinology, Sheba Medical Center
Tel HaShomer, Gush Dan, 52621
Jacob Ilani, DR., +97235303103, Jacob.Ilany2@sheba.health.gov.il
Shmuel Levit, DR., +972508805375, shlevit@gmail.com
- Recruiting
Sheba Medical Center
Tel HaShomer, 52621
About this study
Official title: Comparison of Modern Premixed Insulin and Basal-Bolus Regimens on Blood Glucose Control Using CGMS Device in Optimally-controlled Subjects With DM2.
Intensive Insulin Therapy (IIT) may be given in Type 2 Diabetes (T2DM) in two different ways :
- as Basal/bolus therapy (B/B) in four-five injections per day .
- as Modern Premixed Insulins( MPI's) three times per day . The better diabetes control is achieved, the more likely patient would suffer from hypoglycemic episodes. We propose that the probability of hypoglycemia and its severity has no difference in two main insulin therapy schemes mentioned above.
The objective of the study is to compare the incidence of hypoglycemia and its severity in well-controlled ( HBA1C less than 7%) diabetic individuals treated by two different regimens, through analysis of data received by Continuous Glucose Monitoring (CGM, Free Style Navigator).
- Conditions
- Diabetes Mellitus 2 Type
- Keywords
- continuous glucose monitoring system, hypoglycemia, insulin regimen, basal bolus therapy, modern premixed insulin, diabetes control
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoglycemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus 2 TypeStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627509
- Sponsor's protocol ID
- SHEBA-10-7894-JI-CTIL
- Status last verified
- Jun 2012
- First submitted
- 21 Jun 2012
- Last updated
- 25 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Modern Premixed Insulin and Basal-Bolus Regimens on Blood Glucose Control Using CGMS Device in Optimally-controlled Subjects With DM2.
- ClinicalTrials.gov ID
- NCT01627509
- Acronym / sponsor ID
- SHEBA-10-7894-JI-CTIL
- Conditions
- Diabetes Mellitus 2 Type
- Keywords
- continuous glucose monitoring system, hypoglycemia, insulin regimen, basal bolus therapy, modern premixed insulin, diabetes control
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- May 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 25 Jun 2012 (estimated)
- 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.
Intensive Insulin Therapy (IIT) may be given in Type 2 Diabetes (T2DM) in two different ways :
- as Basal/bolus therapy (B/B) in four-five injections per day .
- as Modern Premixed Insulins( MPI's) three times per day . The better diabetes control is achieved, the more likely patient would suffer from hypoglycemic episodes. We propose that the probability of hypoglycemia and its severity has no difference in two main insulin therapy schemes mentioned above.
The objective of the study is to compare the incidence of hypoglycemia and its severity in well-controlled ( HBA1C less than 7%) diabetic individuals treated by two different regimens, through analysis of data received by Continuous Glucose Monitoring (CGM, Free Style Navigator).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 40 Subjects with 1 year and more of T2DM history , with two consistent HbA1C values of 7% or less - according to the blood tests within last six months.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2012.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus 2 Type, run by Sheba Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 25 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacob Ilani, Dr. (+97235303103, Jacob.Ilany2@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 25 Jun 2012.