Safety of Closed-loop Hybrid Insulin Administration Durin... | NCT05747352

Studies
Safety of Closed-loop Hybrid Insulin Administration During Ramadan Fasting in People Living With Type 1 Diabetes

NCT05747352

Sponsor

Centre Hospitalier Sud Francilien

Status

Completed

Last Update Posted

Nov 7, 2023Actual

Enrollment

23Actual

Phase

Not provided

Conditions

Type1diabetes

Interventions

closed-loop hybrid insulin administration

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 5, 2023Actual

Primary Completion Date

Sep 13, 2023Actual

Completion Date

Sep 13, 2023Actual

First Submitted Date

Feb 17, 2023

First Submission Date that Met QC Criteria

Feb 17, 2023

First Posted Date

Feb 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2023

Last Update Posted Date

Nov 7, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Fasting in Ramadan is not recommended for people with type 1 diabetes. The main risk associated with fasting is dysglycemia (hypoglycemia, hyperglycemia, diabetic ketosis) and dehydration. Nevertheless, whether or not to practice Ramadan remains a personal choice and many people living with diabetes choose to perform this fast with or without their physician's approval. The purpose of this prospective observational study is to evaluate the safety and efficacy of an closed-loop hybrid insulin system on glycemic parameters and the level of hypoglycemia in patients with type 1 diabetes who wished to fast during Ramadan.

Detailed Description

Primary objective: to evaluate the efficacy of an closed-loop hybrid insulin system on continuous glucose monitoring (CGM) glycemic parameters during the Ramadan fasting period Primary endpoint : to compare the time spent in the 3.9-10.0 mmol/l glucose target (TIR) from 30 days prior to the Ramadan fasting period to 30 days during the fasting period

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
closed-loop hybrid insulin administration	Other	observational non-interventional study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glucose time	time spent in the 3.9-10.0 mmol/l glucose target (TIR)) in the Ramadan period	Day 30

Secondary Outcomes

Measure	Description	Time Frame
Glucose time	The time spent in the 3.9-10.0 mmol/l glucose target (TIR)) in 30 days prior the Ramadan period	Day 60
Glucose time	time spent below target 3.9 mmol/l

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age > 18 years
type 1 diabetes for > 1 year
on using closed-loop hybrid insulin administration
scheduled Ramadan fasting
patient put on using closed-loop hybrid insulin administration more than 2 months before the start of the Ramadan fast
percentage of continuous glucose monitoring sensor wear > 70% in at least one of the two 30-day periods

Exclusion Criteria:

patient put on using closed-loop hybrid insulin administration less than 2 months before the start of the Ramadan fast
patient who is pregnant or wants to become pregnant immediately
patient informed of the study who objected to the collection of his/her data.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

People with type 1 Diabetes

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dured DARDARI, MD	Centre Hospitalier Sud Francilien	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Sud Francilien		Corbeil-Essonnes		91106	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38888435	Derived	Outenah C, Ly Sall K, Penfornis A, Amadou C, Dardari D. Automated Insulin Delivery System: A Solution for Moderate to High-Risk Ramadan Fasting in People Living with Type 1 Diabetes. Diabetes Technol Ther. 2024 Nov;26(11):e881-e884. doi: 10.1089/dia.2024.0168. Epub 2024 Jul 17.