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

Type1diabetes Clinical Trial

— CGMIP  

Official title:

Assessement of the Influence of Continuous Glucose Measurement on Glucose Control of Type 1 Diabetic Patients Treated by Implanted Insulin Pump

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03048227
• Other study ID #: UF9773
• Status: Terminated
• Phase: N/A
• Start date: April 21, 2017
• Est. completion date: March 21, 2020

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: March 21, 2020
• Est. primary completion date: March 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

Device:
• Continuous Glucose Measurement (CGM)
Patients will manage their diabetes with the help of Continuous Glucose Measurements (Abbott Freestyle Navigator II).

Locations

Country	Name	City	State
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	Chu de Nancy	Nancy	Vandoeuvre-les-nancy
France	AP - Hôpitaux de Paris	Paris
France	CHRU de Strasbourg	Strasbourg
France	Chu de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time spent with glucose	Time spent with glucose between 70-180mg/dL	last 20 days of intervention period
Secondary	HbA1c	HbA1c	last 20 days of intervention period
Secondary	Time spent in hypoglycaemia	Time spent in hypoglycaemia (<70mg/dL)	last 20 days of intervention period
Secondary	Time spent in hyperglycemia	Time spent in hyperglycemia (>180mg/dL)	last 20 days of intervention period
Secondary	Time spent in glucose range	Time spent in glucose range [70-180] and [80-140] mg/dL	last 20 days of intervention period
Secondary	Glucose mean and standard deviation	Glucose mean and standard deviation	last 20 days of intervention period
Secondary	Low Blood Glucose Index (LBGI)	Low Blood Glucose Index (LBGI)	last 20 days of intervention period
Secondary	High Blood Glucose Index (HBGI)	High Blood Glucose Index (HBGI)	last 20 days of intervention period
Secondary	Glucose Variability	Glucose Variability: MARD : Mean Absolute Relative Difference	last 20 days of intervention period
Secondary	Glucose Variability	Glucose Variability: MAGE : Mean Amplitude of Glucose Excursions; -MODD : Mean Of daily blood Glucose Difference	last 20 days of intervention period
Secondary	Glucose Variability	Glucose Variability: MODD : Mean Of daily blood Glucose Difference	last 20 days of intervention period
Secondary	Number of symptomatique hypoglycaemia, severe et non severe	Number of symptomatique hypoglycaemia, severe et non severe	last 20 days of intervention period
Secondary	Number of pump programmation	Number of pump programmation	last 20 days of intervention period
Secondary	Percentage of sensor use	Percentage of sensor use	last 20 days of intervention period
Secondary	Score of Quality of Life questionnaire (IDSRQ)	Score of Quality of Life questionnaire (IDSRQ)	last 20 days of intervention period