NCT03605979

Brief Summary

Looking for strict normoglycemia in type 1 diabetes increases the risk of hypoglycemia, exposing to hypoglycemia unawareness. It has been shown that the early correction of hypoglycemia can help recovering the perception of hypoglycemia. The purpose of this prospective study was to assess the value of sensor-augmented insulin-pump therapy to treat hypoglycemia unawareness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
Last Updated

July 30, 2018

Status Verified

July 1, 2018

Enrollment Period

7 months

First QC Date

July 19, 2018

Last Update Submit

July 27, 2018

Conditions

Type 1 Diabetes

Keywords

type 1 diabeteshypoglycemia unawarenessInsulin pumpContinuous glucose monitoring systemsLow glucose suspend

Outcome Measures

Primary Outcomes (4)

  • Glycemia measured by continuous glucose monitoring (CGM) and pump

    Day 0

  • Glycemia measured by continuous glucose monitoring (CGM) and pump

    day 10

  • Glycemia measured by continuous glucose monitoring (CGM) and pump

    Month 2

  • Glycemia measured by continuous glucose monitoring (CGM) and pump

    Month 3

Study Arms (1)

diabetes group

Patient with hypoglycemia unawareness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with hypoglycemia unawareness

You may qualify if:

  • \>18 years
  • type 1 diabetes
  • had been treated with insulin pump for more than three months
  • had hypoglycemia unawareness with a hypoglycemia perception threshold below 60 mg/dL and/or had had at least one severe hypoglycemia event in the previous year

You may not qualify if:

  • \> 18 years
  • any serious disease that could interfere with the study
  • pregnancy,
  • incompatibility with monitoring,
  • irregular management of diabetes,
  • hearing loss and low vision,
  • preventing them from using the devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

Location

Related Publications (1)

  • Zalzali M, Houdelet-Guerinot V, Socquard E, Thierry A, Delemer B, Lukas-Croisier C. Continuous glucose monitoring and hypoglycemia unawareness in type 1 diabetes: a pilot study. Minerva Endocrinol. 2017 Sep;42(3):195-202. doi: 10.23736/S0391-1977.16.02326-9. Epub 2015 Jul 10.

    PMID: 26159765BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2018

First Posted

July 30, 2018

Study Start

July 1, 2012

Primary Completion

February 1, 2013

Study Completion

June 1, 2013

Last Updated

July 30, 2018

Record last verified: 2018-07

Locations

FR(1)