Condition category
Nutritional, Metabolic, Endocrine
Date applied
15/02/2010
Date assigned
25/03/2010
Last edited
25/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Yoeri Matthijs Luijf

ORCID ID

Contact details

Academic Medical Centre
Dept of Internal Medicine - Clinical Diabetology
Room F4-252
POBox 22660
Amsterdam
1100DD
Netherlands

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 manufacturer’s 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

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

POBox 22660
Amsterdam
1100DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes