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

NCT03970772 | Completed

• 1 other identifier: med-2019-2-2-I-5389
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fasting Hypoglycemia; Diabetes Mellitus, Type 1

Keywords

Type 1 diabetes mellitus; Fasting; Ramadan; Glucagon; Mini-dose; Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Changes in glucose values from baseline to 30 minute

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

  30 minutes

Secondary Outcomes (19)

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

  60 Minutes

• Treatment success from first dose

  60 Minutes

• Mean Glucose Value, during hypoglycemia event by CGM

  60 Minutes

• Time in Range, during hypoglycemia event by CGM

  60 Minutes

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

  60 Minutes

Study Arms (2)

Glucagon injection

EXPERIMENTAL

Dilute Glucagon (1 mg/ml)

Drug: Glucagon Injection

Glucose tablets

ACTIVE COMPARATOR

Dextrose glucose tablets

Other: Glucose Tablets

Interventions

Glucagon Injection 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.

Glucagon injection

Glucose Tablets 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.

Glucose tablets

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of T1DM using daily insulin
• to \< 65.0 years of age with body mass index 20.0 to \<35.0 kg/m2.
• Having diabetes for ≥2.0 years
• HbA1c \<8.5%
• Has a smart phone with access to the internet and welling to upload data during the study period.
• Welling to wear a devise such as continuous glucose monitor ≥6 days/week.
• Females, not currently known to be pregnant
• In good general health as evaluated by investigator based on available clinical data
• Willing to comply to the protocol requirements for the duration of the study

You may not qualify if:

• Any history of more than one severe hypoglycemic episode (need assistance by third party) in the past 12 months
• Any history of more than one episode of diabetic ketoacidosis in the past 12 months
• Female pregnant or planning to get pregnant.
• Use of any of the following medications: oral hypoglycemic agents, systemic corticosteroids or beta-blocker, theophylline, beta-adrenergic agonists, 1st generation anticholinergic drugs.
• History of hypersensitivity to glucagon or severe hypersensitivity reactions (such as angioedema) to any other medications
• History of uncontrolled hypertension (systolic BP \>160 mmHg or diastolic BP \>100 mmHg)
• History of seizure disorder.
• 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.
• Currently following any kind of weight-loss diet
• Currently participation in another clinical trials

Sponsors & Collaborators

• Qassim University: lead

Study Sites (1)

Qassim University

Buraidah, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 35176134 DERIVED

MeSH Terms

Conditions

Hypoglycemia; Diabetes Mellitus, Type 1; Fasting

Interventions

Glucagon; Glucose

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Diabetologist Consultant

Model Details: This is a Randomize Crossover study with a pre-crossover phase and a crossover trial phase, which will include a minimum of 20 participants and consist of two (2-weeks) periods.

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 3, 2019
• Study Start: April 15, 2019
• Primary Completion: June 10, 2019
• Study Completion: August 15, 2019
• Last Updated: July 15, 2021

Record last verified: 2021-07

Locations

SA (1)