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Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump.

Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump. The CLOSE Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03436212
Acronym
CLOSE
Enrollment
24
Registered
2018-02-19
Start date
2017-09-05
Completion date
2018-03-06
Last updated
2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief summary

This study aims at describing the glucose level by automated glucose sensors and correlating it with insulin delivery and meals over 14 days in insulin-requiring T2D patients living in real-life conditions.

Interventions

DEVICEContinuous Glucose Monitoring (CGM)

DEXCOMG4 device

Sponsors

Air Liquide Santé International
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Selection criteria: * Type 2 Diabetes diagnosed for at least 5 years * Treated with insulin pump for at least 6 months * 7.5% ≤ HBA1c ≤ 10% (last available value dated less than 3 months) * Having given his/her free, express and informed consent to participate to the study Inclusion Criteria: * 7.5% ≤ HBA1c ≤ 10% (result of the dosage performed at selection visit) * Daily insulin requirement ≤ 1.5U/kg/day * Having been compliant to take pictures of his/her meals and snacks over the 3 days prior to the inclusion visit Non-selection/Non-inclusion criteria: * Pregnant or breastfeeding woman * Comorbidity which, in the investigator's opinion, could jeopardize the study completion * Patient with difficulties to understand the study procedures or deemed unfit, by the Investigator, to comply with operating instructions of CGM equipment.

Design outcomes

Primary

MeasureTime frameDescription
Relationships between glucose levels and insulin doses14 daysTo describe the relationships between glucose levels and insulin doses between meals and at meal-times in T2D patients using pumps over 14 days.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026