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

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

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.

Study Overview

• Status: Terminated
• Conditions: Type1diabetes
• Intervention / Treatment: Device: Continuous Glucose Measurement (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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33078
    • CHU de Bordeaux
  • Corbeil-essonnes, France, 91100
    • CH SUd Francilien
  • Dijon, France, 77908
    • CHU de Dijon
  • Lille, France, 59037
    • CHRU de Lille
  • Marseille, France, 13005
    • AP - Hôpitaux de Marseille
  • Montpellier, France, 34295
    • Uhmontpellier
  • Paris, France, 75014
    • AP - Hôpitaux de Paris
  • Strasbourg, France, 67091
    • CHRU de Strasbourg
  • Toulouse, France, 31059
    • CHU de Toulouse
  • Vandoeuvre-les-nancy
    • Nancy, Vandoeuvre-les-nancy, France, 54500
      • Chu de Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous Glucose Measurement (CGM); Patients will manage their diabetes with the help of Continuous Glucose Measurements (Abbott Freestyle Navigator II).	Device: Continuous Glucose Measurement (CGM); Patients will manage their diabetes with the help of Continuous Glucose Measurements (Abbott Freestyle Navigator II).
No Intervention: Control; Patients will manage their diabetes as usual as recommended by their care team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time spent with glucose	Time spent with glucose between 70-180mg/dL	last 20 days of intervention period

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Eric RENARD, MD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2017
• Primary Completion (Actual): March 21, 2020
• Study Completion (Actual): March 21, 2020

Study Registration Dates

• First Submitted: January 23, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Type1diabetes; CGM; TIDM; Implantable Pump
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: UF9773

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No