NCT03970772

Mini-Dose Glucagon to Treat Fasting-induced Hypoglycemia During Ramadan

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Qassim University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to develop a new approach for the treatment of fasting induced hypoglycemia during ramadan using mini-dose glucagon.

Detailed description

This study aimed to understand whether subcutaneously-given mini-dose glucagon (MDG) as an alternative to carbohydrate consumption could avert hypoglycemia or treat it effectively in type 1 diabetes patients who choose to fast during Ramadan in observance of their faith. This treatment method could also avert any negative psychological emotions Muslim people with diabetes may experience by ingesting carbohydrates to control hypoglycemia, thereby breaking their fast. Furthermore, it could improve ability to self-manage fasting, which is an important action for their spiritual and overall wellbeing. There will be two phases included in this study: 1. Pre-crossover Phase: Before starting the crossover trial, a pre-crossover phase will conduct to evaluate hypoglycemia eligibility, frequency and compliance. 2. Crossover Trial Phase: The Crossover Trial Phase will include 20 participants and consist of two (2-weeks) periods. Participants who don't develop any hypoglycemic event or failed to complete both periods will be excluded. Participants will be randomized into two groups: 1. Group A in periods one will use MDG and glucose tablets in period two according to the protocol. 2. Group B in periods one will use glucose tablets and MDG in period two according to the protocol. The primary outcome will be the number of treated fasting induced hypoglycemic events.

Conditions

• Fasting Hypoglycemia
• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	Glucagon Injection	Participants will be instructed to check their blood glucose (BG) with study meter once they developed hypoglycemia symptoms, their CGM reads below 70 mg/dl, or when the CGM glucose was trending down and the participant intended to treat to prevent hypoglycemia. Participants will be instructed to check BG with meter 3 times and treat the hypoglycemia event using mini-dose glucagon when their BG in range 40-69 mg/dl according a prescribed protocol.
OTHER	Glucose Tablets	Participants will be instructed to check their blood glucose (BG) with study meter once they developed hypoglycemia symptoms, their CGM reads below 70 mg/dl, or when the CGM glucose was trending down and the participant intended to treat to prevent hypoglycemia. Participants will be instructed to check BG with meter 3 times and treat the hypoglycemia event using glucose tablets when their BG in range 40-69 mg/dl according a prescribed protocol.

Timeline

• Start date: 2019-04-15
• Primary completion: 2019-06-10
• Completion: 2019-08-15
• First posted: 2019-06-03
• Last updated: 2021-07-15

Locations

1 site across 1 country: Saudi Arabia