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New study seeks safer insulin dosing for ramadan fasters with diabetes

NCT ID NCT06826547

Disease control Sponsor: University Tunis El Manar Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study tests two methods for adjusting basal insulin in people with type 2 diabetes who fast during Ramadan. One method follows standard guidelines, while the other uses a personalized carbohydrate fasting test. The goal is to see which approach better controls blood sugar and reduces risks like hypoglycemia. About 60 adults aged 18–70 on insulin will participate.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults aged 18 to 70 years with Type 2 diabetes on a basal insulin regimen (NPH, Detemir, or Glargine) with or without 1 to 2 boluses of rapid-acting insulin. * Diabetes duration of at least 2 years and insulin therapy for at least 6 months. * Patients wishing to fast during Ramadan and having provided informed consent. * Low risk of complications according to the IDF-DAR 2021 risk score or moderate risk for patients who insist on fasting. Non-Inclusion Criteria: * High-risk patients according to IDF-DAR 2021 score \>6, including those with: * Severe renal impairment * Cognitive dysfunction or frailty * Unrecognized hypoglycemia * Unstable cardiovascular disease * Pregnancy * Type 1 diabetes * Type 2 diabetes patients on sulfonylureas or related medications Exclusion Criteria: * Patients who did not follow the study protocol regarding insulin dose adjustments and capillary blood glucose (CBG) self-monitoring. * Fasting discontinuation without medical advice. * Severe complications requiring fasting cessation. * Patients who withdrew their informed consent.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Intermittent Fasting type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus, type 2 treated with insulin Fasting, intermittent Inflammatory markers Ramadan fasting

Contacts and locations

Locations

  • La Rabta Hospital , Endocrinology Department

    Tunis, 1000, Tunisia

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