Efficacy of Coordinated Insulin Boluses in Type 1 Diabetic Patients (COBOL)

Toulouse University Hospital

Status and phase: Completed; Phase 4

Conditions: Type 1 Diabetes

Treatments: Drug: Coordinated bolus; Drug: Normal bolus

Study type: Interventional

Funder types: Other

Identifiers

NCT02229097

13 7029 08

2014-000969-47 (EudraCT Number)

13-074

Details and patient eligibility

About

A recent study suggests that, in Type 1 Diabetes (T1D) patients treated by insulin pumps, a better coordination of meal boluses and post prandial basal rate could reduce the importance of postprandial hyperglycaemias without increasing the risk of delayed hypoglycaemias.

The aim of the investigators study is to assess if these results are confirmed in a clinical trial.

The aim of this study is to compare the efficacy of coordinated boluses versus normal boluses on postprandial glycaemic control of T1D patients treated with continuous subcutaneous insulin infusion.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes mellitus
• with confirmed Negative C-peptide or diabetes duration>5 years
• Treated by external insulin pump and rapid insulin analog for more than 3 months
• using a Medtronic Paradigm Real-Time or Veo™ model
• Educated to and practicing functional insulin treatment and carbohydrate counting for more than 3 months
• Able to use the "basal temp" and "glycaemia reminder" functions of their pump
• Basal infusion rate ≥ 0,5 Unit/h
• Self-monitoring of blood glucose frequency > 4/days
• Aware of hypoglycaemia

Exclusion criteria

• known impaired renal function (creatinin clearance <60ml/min)
• Gastroparesis
• Serious or instable disease likely to induce a glycaemic control deterioration - treatment with corticosteroids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

17 participants in 2 patient groups

Normal then Coordinated

Experimental group

Description:

normal bolus during 2 weeks then coordinated bolus during 2 weeks

Treatment:

Drug: Normal bolus

Drug: Coordinated bolus

Coordinated then Normal

Experimental group

Description:

coordinated bolus during 2 weeks then normal bolus during 2 weeks

Treatment:

Drug: Normal bolus

Drug: Coordinated bolus