Effectiveness of Carbohydrate Counting Method With Mixed Meals

Agricultural University of Athens

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Other: Mixed meal 1; Other: Mixed meal 4; Other: Mixed meal 2; Other: Mixed meal 5; Other: Mixed meal 6; Other: Mixed meal 3

Study type: Interventional

Funder types: Other

Identifiers

NCT02928016

HRBD 11th Session 6/4/2014 NHA

Details and patient eligibility

About

In a randomized, cross-over designed study, the investigators examined the effectiveness of the carbohydrate counting method after consumption of mixed meals typical of the Greek cuisine with various protein and fat contents in a sample of people with type 1 diabetes (DM1). The investigators also tried to further explore the effects of additional extra virgin olive oil (11 ml) on the glycemic response.

Full description

A total of 20 adults with type 1 diabetes on intensive insulin therapy consumed three mixed meals at noon between 1200 and 1300 hours, with and without the addition of 11 ml extra virgin oil, in random order. One week before entering the study, participants kept a detailed 7-day weighed food record with fingerprick blood glucose measurements pre-and-2hour post-meals for calculation of their carbohydrate (g) to insulin (units) ratio. Moreover, the individual correction factor was calculated. Thereafter, insulin requirements for the test meals were calculated based on the carbohydrate content of each dish and according to the personalised carbohydrate to insulin ratio. Postprandial glycemia was measured in capillary blood glucose samples at 30min intervals over 195min. For 24hr before each testing session, participants were asked to refrain from the consumption of alcohol and to maintain their usual physical activity pattern. On the day of testing, subjects were asked to consume their usual breakfast and abstain from food for at least 2 hours before their appointment. If blood glucose was >7.2 mmol/l at 1200, insulin was administered based on the individualised correction factor. If blood glucose was >10 mmol/l at the beginning of the testing session, insulin was administered to correct it and the subject was asked to return on another day. if hypoglycaemia occurred (defined as blood glucose level <3.8 mmol/l), the test session was stopped, the event was recorded and the patient treated appropriately. The on target 2hour postprandial blood glucose level was set between 3.9 and 10 mmol/l. Anthropometric measurements (body weight, waist and hip circumferences) were performed at every visit.

Enrollment: 120 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with type 1 diabetes
• Intensive insulin therapy
• HbA1c < 10%
• >2 years with diabetes

Exclusion criteria

• Food allergies
• Diabetic neuropathy
• Kidney disease
• Hematological disturbances
• Liver disease
• Uncontrolled hypo- or hyperthyroidism
• Arrhythmia
• Heart disease
• Cancer
• Serious mental illness

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

120 participants in 6 patient groups

Mixed meal 1

Experimental group

Description:

20 adults with type 1 diabetes (T1DM) on intensive insulin treatment and glycated haemoglobin (HbA1c) \<10% consumed three ready-made standardised mixed meals (a dish made with thick pasta, minced meat and béchamel sauce, grilled chicken with vegetables and baked giant beans) with and without the addition of 11 ml of extra virgin olive oil within 20 minutes. No other food or drink (except for water) were consumed until the end of the trial period (total duration 195 minutes). Participants consumed all meals in random order during 6 consecutive visits with one week wash-out period in between visits.

Treatment:

Other: Mixed meal 1

Mixed meal 2

Experimental group

Description:

20 adults with type 1 diabetes (T1DM) on intensive insulin treatment and glycated haemoglobin (HbA1c) \<10% consumed three ready-made standardised mixed meals (a dish made with thick pasta, minced meat and béchamel sauce, grilled chicken with vegetables and baked giant beans) with and without the addition of 11 ml of extra virgin olive oil within 20 minutes. No other food or drink (except for water) were consumed until the end of the trial period (total duration 195 minutes). Participants consumed all meals in random order during 6 consecutive visits with one week wash-out period in between visits.

Treatment:

Other: Mixed meal 2

Mixed meal 3

Experimental group

Description:

20 adults with type 1 diabetes (T1DM) on intensive insulin treatment and glycated haemoglobin (HbA1c) \<10% consumed three ready-made standardised mixed meals (a dish made with thick pasta, minced meat and béchamel sauce, grilled chicken with vegetables and baked giant beans) with and without the addition of 11 ml of extra virgin olive oil within 20 minutes. No other food or drink (except for water) were consumed until the end of the trial period (total duration 195 minutes). Participants consumed all meals in random order during 6 consecutive visits with one week wash-out period in between visits.

Treatment:

Other: Mixed meal 3

Mixed meal 4

Experimental group

Description:

20 adults with type 1 diabetes (T1DM) on intensive insulin treatment and glycated haemoglobin (HbA1c) \<10% consumed three ready-made standardised mixed meals (a dish made with thick pasta, minced meat and béchamel sauce, grilled chicken with vegetables and baked giant beans) with and without the addition of 11 ml of extra virgin olive oil within 20 minutes. No other food or drink (except for water) were consumed until the end of the trial period (total duration 195 minutes). Participants consumed all meals in random order during 6 consecutive visits with one week wash-out period in between visits.

Treatment:

Other: Mixed meal 4

Mixed meal 5

Experimental group

Description:

20 adults with type 1 diabetes (T1DM) on intensive insulin treatment and glycated haemoglobin (HbA1c) \<10% consumed three ready-made standardised mixed meals (a dish made with thick pasta, minced meat and béchamel sauce, grilled chicken with vegetables and baked giant beans) with and without the addition of 11 ml of extra virgin olive oil within 20 minutes. No other food or drink (except for water) were consumed until the end of the trial period (total duration 195 minutes). Participants consumed all meals in random order during 6 consecutive visits with one week wash-out period in between visits.

Treatment:

Other: Mixed meal 5

Mixed meal 6

Experimental group

Description:

20 adults with type 1 diabetes (T1DM) on intensive insulin treatment and glycated haemoglobin (HbA1c) \<10% consumed three ready-made standardised mixed meals (a dish made with thick pasta, minced meat and béchamel sauce, grilled chicken with vegetables and baked giant beans) with and without the addition of 11 ml of extra virgin olive oil within 20 minutes. No other food or drink (except for water) were consumed until the end of the trial period (total duration 195 minutes). Participants consumed all meals in random order during 6 consecutive visits with one week wash-out period in between visits.

Treatment:

Other: Mixed meal 6