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

Qassim University20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fasting Hypoglycemia Diabetes Mellitus, Type 1

Interventions

Glucagon InjectionDRUG

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.

Glucose TabletsOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Clinical diagnosis of T1DM using daily insulin 2. 18.0 to \< 65.0 years of age with body mass index 20.0 to \<35.0 kg/m2. 3. Having diabetes for ≥2.0 years 4. HbA1c \<8.5% 5. Has a smart phone with access to the internet and welling to upload data during the study period. 6. Welling to wear a devise such as continuous glucose monitor ≥6 days/week. 7. Females, not currently known to be pregnant 8. In good general health as evaluated by investigator based on available clinical data 9. Willing to comply to the protocol requirements for the duration of the study Exclusion Criteria: 1. Any history of more than one severe hypoglycemic episode (need assistance by third party) in the past 12 months 2. Any history of more than one episode of diabetic ketoacidosis in the past 12 months 3. Female pregnant or planning to get pregnant. 4. Use of any of the following medications: oral hypoglycemic agents, systemic corticosteroids or beta-blocker, theophylline, beta-adrenergic agonists, 1st generation anticholinergic drugs. 5. History of hypersensitivity to glucagon or severe hypersensitivity reactions (such as angioedema) to any other medications 6. History of uncontrolled hypertension (systolic BP \>160 mmHg or diastolic BP \>100 mmHg) 7. History of seizure disorder. 8. Presence of any of conditions based on judgment of the investigator that could affect or interfere with the response, absorption, metabolism or execration of glucagon. 9. Currently following any kind of weight-loss diet 10. Currently participation in another clinical trials

Locations (1)

Qassim University

Buraidah, Saudi Arabia

Outcomes

Primary Outcomes

Changes in glucose values from baseline to 30 minute

The change in blood glucose from baseline to 30 minute following treatment of hypoglycemic events

Time frame: 30 minutes

Secondary Outcomes

Events approached 100 mg/dL or increased by 30 mg/dL

During the first hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will record the events approached 100 mg/dL or increased by 30 mg/dL

Time frame: 60 Minutes

Treatment success from first dose

During the first hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will record the events with blood glucose concentration ≥50 mg/dl 15 minute AND ≥70 mg/dl 30 minute after the initial treatment of a hypoglycemic event

Time frame: 60 Minutes

Mean Glucose Value, during hypoglycemia event by CGM

During the first hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will calculate the mean glucose value from CGM data

Time frame: 60 Minutes

Time in Range, during hypoglycemia event by CGM

During the first hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will calculate the percentage of time in range 70-180 mg/dL from CGM data.

Time frame: 60 Minutes

Time spend below 70 mg/dL, during hypoglycemia event by CGM

During the first hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will calculate the percentage of time \<70 mg/dL from CGM data.

Time frame: 60 Minutes

Minimum Glucose, during hypoglycemia event by CGM

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.