Can Continuous Glucose Measurements Help Diabetic Patients Treated With an Implantated Pump?

NCT ID: NCT03048227

Last Updated: 2021-12-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-21
• Study Completion Date: 2020-03-21

Brief Summary

During this study, we propose to assess the utility of Continuous Glucose Measurements (CGM) in a group of Type 1 diabetic patients treated with an implanted insulin pump. Patients will participate in two period of 3 months separated by a 3 months washout. During one period, they will use CGM to adapt their insulin therapy while during the other period, they will manage their diabetes with their usual capillary blood glucose meter. We except to observe an increase of time spent in glucose safe range when using CGM.

Detailed Description

Glucose control and quality of life of patients with type 1 diabetes with high glucose variability can be improve with use of an implanted pump which delivers insulin by the intra-peritoneal route. Some patients however still have difficulties to achieve their glycemic goal despite this therapy. Continuous Glucose Measurements (CGM) has proven to be able to improve glucose control (HbA1c, time spent in hypoglycaemia) of patients treated with an external insulin pump. No trial has been performed yet to assess the utility of CGM on patients using an intra-peritoneal insulin delivery.

During this study, we propose to assess the influence of CGM use on type 1 diabetic subject treated with implanted insulin pump. It is a prospective, randomized cross-over study. After a 2 weeks run-in period with CGM followed by a 4 weeks break, subjects will participate at two experimental periods of 3 months separated with a 3 month washout. During the intervention phase, patient will use a CGM system (Abbott Freestyle Navigator II) to adapt their insulinotherapy. During the control period, patients will based their insulinotherapy upon their usual care and capillary glucose measurements. The order of the periods will be randomized.

The main endpoint will be the time spent in glucose interval 70-180mg/dL during the last 20 days of each period. The control arm will wear a blinded sensor during this phase to allow comparison.

Conditions

Type1diabetes

Keywords

TIDM; Type1diabetes; Implantable Pump; CGM

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Continuous Glucose Measurement (CGM)

Patients will manage their diabetes with the help of Continuous Glucose Measurements (Abbott Freestyle Navigator II).

Group Type: EXPERIMENTAL

Continuous Glucose Measurement (CGM)

Intervention Type: DEVICE

Patients will manage their diabetes with the help of Continuous Glucose Measurements (Abbott Freestyle Navigator II).

Control

Patients will manage their diabetes as usual as recommended by their care team.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Continuous Glucose Measurement (CGM)

Patients will manage their diabetes with the help of Continuous Glucose Measurements (Abbott Freestyle Navigator II).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age from 18 and 70
• Type 1 diabetes for at least 1 year
• Treatment of diabetes withimplanted insulin pump for at least 6 months
• HbA1c level between 7.5 and 10%
• Minimum of 4 capillary glucose controls per day over past 3 months
• Use of CGM at least 75% during run-in period
• Willingness to follow all study procedures
• Informed consent signed
• Patient must be affiliated or beneficiary of a social medical insurance

Exclusion Criteria

• Pregnancy of breast feeding, or intention to be pregnant during the study duration
• Impaired cognitive or psychological abilities which may result in defective adherence to study procedures
• Any disease which could make the use glucose sensor difficult (ex : blindness, severe arthrosis or immobility)
• Known allergy to medical adhesive or glucose sensor component
• Medication affecting glucose metabolism, unless stable during the study
• Long term use of continuous glucose measurements during pas 6 months
• Pump implanted more than 6 years ago
• Anti-insulin antobodies syndrom
• Active enrollment in another clinical trial or participation in a study within 30 days

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric RENARD, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Chu de Nancy

Nancy, Vandoeuvre-les-nancy, France

CHU de Bordeaux

Bordeaux, , France

CH Sud Francilien

Corbeil-Essonnes, , France

CHU de Dijon

Dijon, , France

CHRU de Lille

Lille, , France

AP - Hôpitaux de Marseille

Marseille, , France

UHMontpellier

Montpellier, , France

AP - Hôpitaux de Paris

Paris, , France

CHRU de Strasbourg

Strasbourg, , France

Chu de Toulouse

Toulouse, , France

Countries

France

Other Identifiers

UF9773

Identifier Type: -

Identifier Source: org_study_id