Diabetes MellitusNCT00464854
Glucose Control With Multiple Daily Insulin Injections In Diabetic Patients Hospitalized In A General Medicine Ward
A study testing Glargine and insulin aspart or lispro in people with Diabetes Mellitus, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
At least 20% of patients hospitalized in the general medical and surgical wards at any given time suffer from diabetes. It has been demonstrated that poor clinical outcome correlates with the degree of hyperglycemia in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Glargine and insulin aspart or lispro
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2005to Sep 2006
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (<18 years) Male and female T1 \& T2DM patients who can sign an informed consent.
- Insulin treatment (at least one injection a day) prior to hospitalization for at least half a year.
Who cannot join
- Diabetic ketoacidosis.
- Hyperosmolar state due to hyperglycemia.
- Pregnancy
- Fertile women who do not use oral contraception or IUD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasiblity, Safety And Efficacy Of Glucose Control With Multiple Daily Insulin Injections In Diabetic Patients Hospitalized In A General Medicine Ward
At least 20% of patients hospitalized in the general medical and surgical wards at any given time suffer from diabetes. It has been demonstrated that poor clinical outcome correlates with the degree of hyperglycemia in these patients. Strict glucose control in hospitalized patients improves clinical outcomes in the setting of acute myocardial infarction, cardiac surgical procedures, infection and critical illness in patients hospitalized in intensive care units if insulin is applied intravenously. It is, however, complex to obtain strict glucose control in the general surgical and medical wards. These wards are usually understaffed as compared to intensive care units and therefore are incapable to perform the necessary close monitoring essential in patients treated with intravenous insulin. We intend to test the feasibility of glucose control by multiple daily subcutaneous injections with long acting basal glargine insulin and pre-meal insulin analogues. If good glucose control can be achieved, this would be a valid, more convenient and acceptable alternative to intravenous insulin infusions to obtain good glucose control in diabetic patients hospitalized in general internal medicine wards.
Read the detailed description
Location of the study:
Internal Medicine Wards C of Assaf Harofe Medical Center, Zerifin, Israel:
Inclusion Criteria:
- Adult (<18 years) Male and female T1 \& T2DM patients who can sign an informed consent.
- Insulin treatment (at least one injection a day) prior to hospitalization for at least half a year.
Exclusion Criteria:
- Diabetic ketoacidosis.
- Hyperosmolar state due to hyperglycemia.
- Pregnancy
- Fertile women who do not use oral contraception or IUD
Concurrent medications:
- The hospital staff will determine the initiation or continuation of oral and intravenous medications as indicated by the patient's medical status.
Admission Blood tests:
- Routine: CBC, Creatinine, Urea, Na, K, GOT, GPT, Alp, Albumin, Glu
- HbA1C \& Fructosamine.
Initiation and Titration of Insulin dosage:
- Glargine insulin will be initiated as a function of the first fasting glucose level and the patients body weight (0.3 - 0.8 U/kg). Up- or down titration will occur every morning by 10 - 20% according to capillary am fasting glucose (goal 130 mg%). The dosage of premeal insulin analogues will be based according to a sliding scale and calculated as a percentage of the amount of am glargine.
- Capillary blood glucose levels were measured seven times a day: before and two hours after breakfast, lunch and dinner and at bedtime. Additional measurements were performed according to clinical needs such as suspected hypoglycemia or unexplained deterioration of clinical condition
- Conditions
- Diabetes Mellitus
- Being tested
- Glargine and insulin aspart or lispro
- Keywords
- Glucose control, Subcutaneous insulin treatment, Multiple daily injections
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glargine and insulin aspart or lisproDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of a fasting blood glucose of 130 mg/dl and a mean daily glucose level of 180 mg/dl during hospitalization
Secondary outcomes (1)
Hypoglycemia of < 60 mg% (symptomatic and asymptomatic)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2007 (estimated)
- Study startJul 2005
- Study completionSep 2006
Why it stopped: The study was started before the official request for protocol registration
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Andreas E Buchs, M.D., Principal investigator, Assaf Harofe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464854
- Sponsor's protocol ID
- AH-2323
- Status last verified
- Apr 2007
- First submitted
- 22 Apr 2007
- Last updated
- 24 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasiblity, Safety And Efficacy Of Glucose Control With Multiple Daily Insulin Injections In Diabetic Patients Hospitalized In A General Medicine Ward
- ClinicalTrials.gov ID
- NCT00464854
- Acronym / sponsor ID
- AH-2323
- Conditions
- Diabetes Mellitus
- Keywords
- Glucose control, Subcutaneous insulin treatment, Multiple daily injections
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was started before the official request for protocol registration
- Enrolment
- 100 participants
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jul 2005
- Study completion
- Sep 2006 (actual)
- First posted
- 24 Apr 2007 (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.
At least 20% of patients hospitalized in the general medical and surgical wards at any given time suffer from diabetes. It has been demonstrated that poor clinical outcome correlates with the degree of hyperglycemia in these patients. Strict glucose control in hospitalized patients improves clinical outcomes in the setting of acute myocardial infarction, cardiac surgical procedures, infection and critical illness in patients hospitalized in intensive care units if insulin is applied intravenously. It is, however, complex to obtain strict glucose control in the general surgical and medical wards. These wards are usually understaffed as compared to intensive care units and therefore are incapable to perform the necessary close monitoring essential in patients treated with intravenous insulin. We intend to test the feasibility of glucose control by multiple daily subcutaneous injections with long acting basal glargine insulin and pre-meal insulin analogues. If good glucose control can be achieved, this would be a valid, more convenient and acceptable alternative to intravenous insulin infusions to obtain good glucose control in diabetic patients hospitalized in general internal medicine wards.
Detailed description
Location of the study:
Internal Medicine Wards C of Assaf Harofe Medical Center, Zerifin, Israel:
Inclusion Criteria:
- Adult (<18 years) Male and female T1 \& T2DM patients who can sign an informed consent.
- Insulin treatment (at least one injection a day) prior to hospitalization for at least half a year.
Exclusion Criteria:
- Diabetic ketoacidosis.
- Hyperosmolar state due to hyperglycemia.
- Pregnancy
- Fertile women who do not use oral contraception or IUD
Concurrent medications:
- The hospital staff will determine the initiation or continuation of oral and intravenous medications as indicated by the patient's medical status.
Admission Blood tests:
- Routine: CBC, Creatinine, Urea, Na, K, GOT, GPT, Alp, Albumin, Glu
- HbA1C \& Fructosamine.
Initiation and Titration of Insulin dosage:
- Glargine insulin will be initiated as a function of the first fasting glucose level and the patients body weight (0.3 - 0.8 U/kg). Up- or down titration will occur every morning by 10 - 20% according to capillary am fasting glucose (goal 130 mg%). The dosage of premeal insulin analogues will be based according to a sliding scale and calculated as a percentage of the amount of am glargine.
- Capillary blood glucose levels were measured seven times a day: before and two hours after breakfast, lunch and dinner and at bedtime. Additional measurements were performed according to clinical needs such as suspected hypoglycemia or unexplained deterioration of clinical condition
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (<18 years) Male and female T1 \& T2DM patients who can sign an informed consent.
- Insulin treatment (at least one injection a day) prior to hospitalization for at least half a year.
Key exclusion criteria (4 listed)
- Diabetic ketoacidosis.
- Hyperosmolar state due to hyperglycemia.
- Pregnancy
- Fertile women who do not use oral contraception or IUD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glargine and insulin aspart or lispro | Drug | – |
Primary outcome
Achievement of a fasting blood glucose of 130 mg/dl and a mean daily glucose level of 180 mg/dl during hospitalization
1 secondary outcome
Hypoglycemia of < 60 mg% (symptomatic and asymptomatic)
Results and safety
The study was stopped early (reason given: The study was started before the official request for protocol registration). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2007.
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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.
Andreas E Buchs, M.D. principal investigator
Assaf Harofe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glargine and insulin aspart or lispro in people with Diabetes Mellitus, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 24 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: The study was started before the official request for protocol registration). Results are not available in the source record.
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?
Achievement of a fasting blood glucose of 130 mg/dl and a mean daily glucose level of 180 mg/dl during hospitalization. It is what the study was designed to measure, not a finding.
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 24 Apr 2007.