Optimal time of mealtime insulin administration in people with type 1 diabetes

Optimal Lag Time Study: Optimal timing of rapid-acting insulin analogues administration before meals

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13984129

Enrollment

Registered

2010-03-25

Start date

2009-10-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes and postprandial glycemic conditions. Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus

Interventions

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 SofSens

-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

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026