Clinical trial NCT00464854: Glucose Control With Multiple Daily Insulin Injections In Diabetic Patients Hospitalized In A General Medicine Ward
Official title: Feasiblity, Safety And Efficacy Of Glucose Control With Multiple Daily Insulin Injections In Diabetic Patients Hospitalized In A General Medicine Ward
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Glucose control
Subcutaneous insulin treatment
Multiple daily injections
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-04-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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

Eligibility criteria: 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

Primary outcomes:
measure: Achievement of a fasting blood glucose of 130 mg/dl and a mean daily glucose level of 180 mg/dl during hospitalization
Secondary outcomes:
measure: Hypoglycemia of < 60 mg% (symptomatic and asymptomatic)
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofe Medical Center
Study officials:
affiliation: Assaf Harofe Medical Center
name: Andreas E Buchs, M.D.
role: PRINCIPAL_INVESTIGATOR
References: