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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03048227
Recruitment Status : Terminated (CGM Navigator isn't longer available (October 11, 2019))
First Posted : February 9, 2017
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Tracking Information
First Submitted Date  ICMJE January 23, 2017
First Posted Date  ICMJE February 9, 2017
Last Update Posted Date May 4, 2020
Actual Study Start Date  ICMJE April 21, 2017
Actual Primary Completion Date February 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2017)
Time spent with glucose [ Time Frame: last 20 days of intervention period ]
Time spent with glucose between 70-180mg/dL
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2017)
  • HbA1c [ Time Frame: last 20 days of intervention period ]
    HbA1c
  • Time spent in hypoglycaemia [ Time Frame: last 20 days of intervention period ]
    Time spent in hypoglycaemia (<70mg/dL)
  • Time spent in hyperglycemia [ Time Frame: last 20 days of intervention period ]
    Time spent in hyperglycemia (>180mg/dL)
  • Time spent in glucose range [ Time Frame: last 20 days of intervention period ]
    Time spent in glucose range [70-180] and [80-140] mg/dL
  • Glucose mean and standard deviation [ Time Frame: last 20 days of intervention period ]
    Glucose mean and standard deviation
  • Low Blood Glucose Index (LBGI) [ Time Frame: last 20 days of intervention period ]
    Low Blood Glucose Index (LBGI)
  • High Blood Glucose Index (HBGI) [ Time Frame: last 20 days of intervention period ]
    High Blood Glucose Index (HBGI)
  • Glucose Variability [ Time Frame: last 20 days of intervention period ]
    Glucose Variability: MARD : Mean Absolute Relative Difference
  • Glucose Variability [ Time Frame: last 20 days of intervention period ]
    Glucose Variability: MAGE : Mean Amplitude of Glucose Excursions -MODD : Mean Of daily blood Glucose Difference
  • Glucose Variability [ Time Frame: last 20 days of intervention period ]
    Glucose Variability: MODD : Mean Of daily blood Glucose Difference
  • Number of symptomatique hypoglycaemia, severe et non severe [ Time Frame: last 20 days of intervention period ]
    Number of symptomatique hypoglycaemia, severe et non severe
  • Number of pump programmation [ Time Frame: last 20 days of intervention period ]
    Number of pump programmation
  • Percentage of sensor use [ Time Frame: last 20 days of intervention period ]
    Percentage of sensor use
  • Score of Quality of Life questionnaire (IDSRQ) [ Time Frame: last 20 days of intervention period ]
    Score of Quality of Life questionnaire (IDSRQ)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Can Continuous Glucose Measurements Help Diabetic Patients Treated With an Implantated Pump?
Official Title  ICMJE Assessement of the Influence of Continuous Glucose Measurement on Glucose Control of Type 1 Diabetic Patients Treated by Implanted Insulin Pump
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Type1diabetes
Intervention  ICMJE Device: Continuous Glucose Measurement (CGM)
Patients will manage their diabetes with the help of Continuous Glucose Measurements (Abbott Freestyle Navigator II).
Study Arms  ICMJE
  • Experimental: Continuous Glucose Measurement (CGM)
    Patients will manage their diabetes with the help of Continuous Glucose Measurements (Abbott Freestyle Navigator II).
    Intervention: Device: Continuous Glucose Measurement (CGM)
  • No Intervention: Control
    Patients will manage their diabetes as usual as recommended by their care team.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 30, 2020)
15
Original Estimated Enrollment  ICMJE
 (submitted: February 7, 2017)
28
Actual Study Completion Date  ICMJE October 11, 2019
Actual Primary Completion Date February 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03048227
Other Study ID Numbers  ICMJE UF9773
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: NC
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric RENARD, MD University Hospital, Montpellier
PRS Account University Hospital, Montpellier
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP