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

NCT ID: NCT03970772

Last Updated: 2021-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2019-08-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Glucagon injection

Dilute Glucagon (1 mg/ml)

Group Type: EXPERIMENTAL

Glucagon Injection

Intervention Type: DRUG

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 tablets

Dextrose glucose tablets

Group Type: ACTIVE_COMPARATOR

Glucose Tablets

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qassim University

OTHER

Sponsor Role: lead

Responsible Party

Metab Algeffari

Associate Professor, Diabetologist Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Qassim University

Buraidah, , Saudi Arabia

Countries

Saudi Arabia

References

Algeffari M, Hussain S, Almogbel T, Alsharidah M, Alghadouni H, Mahmood F. Home Use of Mini-Dose Glucagon As a Novel Treatment for Hypoglycemia Following Repeated, Prolonged Fasts in Type 1 Diabetes During Ramadan. Diabetes Care. 2022 Apr 1;45(4):990-993. doi: 10.2337/dc21-1655.

Reference Type: DERIVED

PMID: 35176134 (View on PubMed)

Other Identifiers

med-2019-2-2-I-5389

Identifier Type: -

Identifier Source: org_study_id