Initial Testing of the Diabeloop Algorithm in T1D Patients on Pump Therapy Over the Prandial Period and Physical Activity.

NCT01754181 | Completed Phase 3

• 1 other identifier: 2012-A01489-34
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

Brief Summary

The main objective is to assess if the Diabeloop algorithm provides better glycemic control than a "manual" usual algorithm of patients with type 1 diabetes treated by insulin pump during meals, and during activity qualified "moderate" to "severe" by the patients. The study will be conducted in 18 patients. The investigation centers are: CHSF (for Diabeloop algorithm test during activity), CHU of Grenoble and CHU of Toulouse (for Diabeloop algorithm test during meals.

Conditions

Type 1 Diabetes

Keywords

Glycemic control algorithm; closed loop; artificial pancreas

Outcome Measures

Primary Outcomes (1)

• Time spent in glucose reference intervals

  After the end of the tests

Secondary Outcomes (1)

• Measuring glucose sensor 2h, 3h and 4h post-prandial and AUC, in every situation tested to evaluate the efficacy and safety (time spent in hypoglycemia)

  After the end of the tests

Other Outcomes (1)

• Comparison of glucose sensor 2h, 3h and 4h post-prandial and AUC in conditions identical meals for each trigger level (50 or 75%). Measuring AUC during and 2 hours after physical activity, then to lunch time, during dinner and throughout the night.

  After the end of the tests

Study Arms (2)

Proposed treatment by Diabeloop algorithm

EXPERIMENTAL

the insulin dose is calculated by the algorithm based on the usual treatment of the patient, the ratio I / C, the intensity of physical activity and blood glucose sensor.

Drug: Insulin

usual treatment

NO INTERVENTION

Interventions

Insulin DRUG

the intervention is applied only at the dose of insulin

Proposed treatment by Diabeloop algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with type 1 diabetes treated by external insulin pump;
• Patients with HbA1c \<8.5%.
• Patients aged 18 years or less;
• Patient who signed consent;
• Patient affiliated with Social Security.
• For Grenoble and Toulouse Centers (Prandial algorithm test : MEAL):
• Patient is practicing functional insulin therapy is a fixed meal plan.
• For CHSF center (test of algorithm during activity):
• Patient able to perform moderate or intense activity during 30 minutes.

You may not qualify if:

• Patients with type 2 diabetes
• All serious diseases that could interfere with the study
• Insulin resistance and obesity (BMI\> 30 kg/m2 and / or insulin requirements\> 2 U / kg / day)

Sponsors & Collaborators

• Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète: lead

Study Sites (3)

Centre Hospitalier Sud Francilien

Évry, 91058, France

Location

University Hospital of Grenoble

Grenoble, 38043, France

Location

University Hospital of Toulouse

Toulouse, 31403, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Sylvia FRANC, MD

  Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

  PRINCIPAL INVESTIGATOR

• Pierre-Yves BENHAMOU, Pr.

  CHU of Grenoble

  PRINCIPAL INVESTIGATOR

• Guillaume CHARPENTIER, MD

  Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 21, 2012
• Study Start: March 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 27, 2014

Record last verified: 2014-10

Locations

FR (3)