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OpenTrials
Completed

NCT Number: NCT05747352

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

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.

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Key information

Conditions

Type1diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

closed-loop hybrid insulin administration

Other

observational non-interventional study

Primary outcomes

  1. Glucose time

    Time frame: Day 30

    time spent in the 3.9-10.0 mmol/l glucose target (TIR)) in the Ramadan period

Secondary outcomes

  1. Glucose time

    Time frame: Day 60

    The time spent in the 3.9-10.0 mmol/l glucose target (TIR)) in 30 days prior the Ramadan period

  2. Glucose time

    Time frame: Day 30

    time spent below target 3.9 mmol/l

  3. Glucose time

    Time frame: Day 60

    time spent below target 2.97 mmol/l, between 2.97 and 3.79 mmol/l, between 9.05 mmol/l and 12.5mmol/l and > 12.5 mmol/l

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Official study title

Evaluation of the Glycemic Profile During the Ramadan Fasting in People With Type 1 Diabetes Treated With Closed-loop Hybrid Insulin System

Acronym: RAMDAM

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2023
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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