Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Optimal Lag Time Study: Optimal timing of rapid-acting insulin analogues administration before meals
Acronym
OLTS
Study hypothesis
We hypothesize that mealtime insulin administration at 30 or 15 minutes before the start of a meal will result in reduced postprandial glycemic excursions when compared to insulin
administration simultaneously with the start of a meal.
Ethics approval
The Medical Ethical Committee of Academic Medical Centre, Amsterdam approved on the 22nd of January 2009 (ref: MEC 08/349 # 09.17.0121)
Study design
Single-centre randomised open label controlled crossover intervention study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Type 1 diabetes and postprandial glycemic conditions.
Intervention
Ten type 1 diabetics who had been on CSII for at least six months were included in the study. On the day before the first test meal, patients received a subcutaneous CGM sensor (Medtronic CGMS SofSensor) during a visit to the outpatient clinic and were instructed to calibrate the sensor at home according to the manufacturers specifications.
The next day at 08:00 am, patients reported on an empty stomach to the clinical research unit and were admitted. Patients received an intravenous catheter for blood collection. Before the start of the daily study protocol blood glucose was measured by finger prick. If blood glucose was between 3.0 mmol/L and 7.8 mmol/L, the study protocol would commence immediately. If the blood glucose was too high, intravenous insulin aspart was administered. If blood glucose had been corrected to acceptable parameters and if these values remained stable (excursions < 0.6mmol/L) over a period of 1 hour, the study protocol commenced.
Patients were randomized on each study day by means of opaque, sealed envelopes which were sequentially numbered, between insulin bolus administration at three strata; -30, -15 or 0 minutes before the meal. Each patient was provided with a meal that was comparable to their regular morning meal, the meal for one individual patient did not differ over study days. The first hour before the meal blood was sampled every 15 minutes, the first 2 hours after the meal every 10 minutes and the third and fourth hour after the meal every 20 minutes. Blood samples were collected in 2cc sodium fluoride tubes for determination of blood glucose. The insulin bolus was administered by the patients according to their own calculation of carbohydrates in the meal (at this point estimated to be between 4 and 12 IU per meal, depending on the patient and their respective meals).
After the test meal and blood collection, patients would go home continuing to wear the CGM sensor and reported back to the clinical research unit the next day to continue the protocol until all three insulin administration strata had been completed.
After the three study-meals, there is no additional follow-up.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
All outcomes in this study are outcomes derived from the postprandial glucose curve, and as such are a measure of postprandial glucose control on the three study days until 5 hours postprandially.
Secondary outcome measures
1. Continuous Glucose Monitoring (CGM) values
2. Number and duration of hypoglycemias
3. Maximum swing of blood-glucose levels
4. Highest blood glucose levels
5. Lowest blood glucose levels
6. Time spent in hyperglycemia
Overall trial start date
01/10/2009
Overall trial end date
30/03/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Men or women aged from 18 to 75 years
2. Type 1 diabetes according to the WHO definition
3. Treated with insulin for at least 2 years and by Continuous Subcutaneous Insulin Infusion (CSII) for at least 6 months
4. Body mass index (BMI) < 35 kg/m2
5. Written informed consent
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
10
Participant exclusion criteria
1. Pregnancy (women of childbearing potential must have an adequate contraception) or
breastfeeding
2. Treatment with systemic corticosteroids
3. Treatment with oral antidiabetics within 1 week prior to the first study day
4. Impaired renal function as shown by serum creatinine ≥ 133 umol/l in men or ≥ 124 umol/l in women
5. Known impaired hepatic function defined as alanine aminotransferase (ALAT) and / or aspartamine aminotransferase (ASAT) three times greater the upper limit of the normal range
6. Alcohol or drug abuse in the last year
7. Mental condition rendering the patient unable to understand the nature and scope of the
study
Recruitment start date
01/10/2009
Recruitment end date
30/03/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre
Amsterdam
1100DD
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Centre (AMC) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary