NCT03048227

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

April 21, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2020

Completed
Last Updated

December 9, 2021

Status Verified

December 1, 2021

Enrollment Period

2.9 years

First QC Date

January 23, 2017

Last Update Submit

December 8, 2021

Conditions

Type1diabetes

Keywords

TIDMType1diabetesImplantable PumpCGM

Outcome Measures

Primary Outcomes (1)

  • Time spent with glucose

    Time spent with glucose between 70-180mg/dL

    last 20 days of intervention period

Secondary Outcomes (14)

  • HbA1c

    last 20 days of intervention period

  • Time spent in hypoglycaemia

    last 20 days of intervention period

  • Time spent in hyperglycemia

    last 20 days of intervention period

  • Time spent in glucose range

    last 20 days of intervention period

  • Glucose mean and standard deviation

    last 20 days of intervention period

  • +9 more secondary outcomes

Study Arms (2)

Continuous Glucose Measurement (CGM)

EXPERIMENTAL

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

Device: Continuous Glucose Measurement (CGM)

Control

NO INTERVENTION

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

Interventions

Continuous Glucose Measurement (CGM)DEVICE

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

Continuous Glucose Measurement (CGM)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Chu de Nancy

Nancy, Vandoeuvre-les-nancy, 54500, France

Location

CHU de Bordeaux

Bordeaux, 33078, France

Location

CH Sud Francilien

Corbeil-Essonnes, 91100, France

Location

CHU de Dijon

Dijon, 77908, France

Location

CHRU de Lille

Lille, 59037, France

Location

AP - Hôpitaux de Marseille

Marseille, 13005, France

Location

UHMontpellier

Montpellier, 34295, France

Location

AP - Hôpitaux de Paris

Paris, 75014, France

Location

CHRU de Strasbourg

Strasbourg, 67091, France

Location

Chu de Toulouse

Toulouse, 31059, France

Location

Study Officials

  • Eric RENARD, MD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2017

First Posted

February 9, 2017

Study Start

April 21, 2017

Primary Completion

March 21, 2020

Study Completion

March 21, 2020

Last Updated

December 9, 2021

Record last verified: 2021-12

Locations

FR(10)