Pharmacist-Led Study in Controlling Hypoglycemia in Older Adults With Type 2 Diabetes Mellitus

NCT04081766 | Completed

• 1 other identifier: 2019-May-0170
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

This study involves two parts: a randomised controlled trial, and a nested qualitative study. The main aim of the trial is to evaluate the effectiveness of a pharmacist-led, medications-focused patient counselling on reducing the frequency of hypoglycaemia in older adults diagnosed with type 2 Diabetes Mellitus within 12 weeks in Jordan. The study hypothesis is that individualised patient counselling which is provided by pharmacists and involves recommendations about anti-diabetic medications will reduce the risk of hypoglycaemia by preventing further episodes in the elderly Jordanians with type 2 Diabetes Mellitus. The qualitative study aims at evaluating the experience of participants in both groups with the study (process evaluation). This involves exploring which components are effective and which are not with the reasons, the contextual factors affecting the delivery and implementation of the study and the intervention, and how the study and the intervention can be scaled up in the future.

Conditions

Diabetes Mellitus Type 2 With Hypoglycemia

Keywords

Diabetes Mellitus, Type 2; Diabetes Mellitus; Hypoglycemia; Counseling; Older Adults

Outcome Measures

Primary Outcomes (1)

• Frequency of total episodes of hypoglycaemia

  The frequency of hypoglycemia will be calculated as the number of total hypoglycemic episodes/person/ 12 weeks. Total hypoglycemia is defined as the summation of severe, symptomatic, and asymptomatic episodes of hypoglycaemia.

  12 weeks

Secondary Outcomes (5)

• Frequency of severe hypoglycaemia

  12 weeks

• Frequency of asymptomatic hypoglycemia

  12 weeks

• Frequency of symptomatic hypoglycemia

  12 weeks

• Proportion of patients experiencing hypoglycaemia

  12 weeks

• Time to the first hypoglycaemic attack

  12 weeks

Study Arms (2)

SUGAR Handshake

ACTIVE COMPARATOR

Participants assigned to the intervention group will receive an individualised, pharmacist-led patient counselling session (SUGAR Handshake package) at the inclusion visit. Participants will also receive a pictogram with the main instructions for easy recall of the counselling contents. They will also receive a glucometer and test strips with a demonstration on proper use, to measure their fasting blood glucose levels on a daily basis for 12 weeks. At week 6, participants will receive a phone call to reinforce the intervention and to remind them of the study protocol. For the qualitative evaluation of the intervention, a number of participants are interviewed and asked questions through the sixth week-phone call. Additionally, participants in this group will be provided with the usual care that is normally provided in the outpatient clinics at King Abdullah University Hospital.

Behavioral: SUGAR Handshake

Control

NO INTERVENTION

Participants within this group will receive the usual care provided by the health care professionals in the outpatient clinics at King Abdullah University Hospital. They will also be provided with instructions on hypoglycemia diagnosis, and treatment and a demonstration on glucometer use at the inclusion visit. They will be asked to measure their fasting blood glucose level daily for 12 weeks. Participants will receive a phone call at week 6 of the inclusion visit to remind them of measuring blood glucose levels and documenting hypoglycemic episodes on the diaries., plus a counselling session about hypoglycaemia recognition and treatment at the inclusion visit. For the qualitative evaluation of the study, a number of participants will be interviewed and asked questions through the sixth week-phone call.

Interventions

SUGAR Handshake BEHAVIORAL

An interactive patient counselling session delivered by a pharmacist which mainly focuses on medication-related instructions towards preventing hypoglycaemia in addition to recommendations about hypoglycemia early recognition, causes, and treatment. The SUGAR Handshake is individualised according to shared decision making and each participant's characteristics. Components of the SUGAR Handshake intervention will be covered under five main domains: 1. Signs and symptoms of hypoglycemia. 2. Understanding the underlying causes of hypoglycaemia such as misuse of anti-diabetic medications. 3. Good glycaemic control and self-monitoring, which mainly includes instructions on handling the anti-diabetic medications. 4. Acknowledgement by the patient 5. Recap and summary The pictogram contains the main recommendations for easy recall by the participant. Moreover, the intervention will be reinforced by a phone call at week 6 of the inclusion visit.

SUGAR Handshake

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of type 2 Diabetes Mellitus
• Have been taking a sulfonylurea, insulin, or any three or more anti-diabetic medications

You may not qualify if:

• Unable to understand instructions or to give consent.
• Impaired mental capacity
• On palliative care for cancer, with advanced-stage or end-stage diseases, who have psychosis or severe depression, who are terminally-ill, or with life expectancy \< 6 months
• Have been diagnosed with haemolytic anaemia or hemoglobinopathies as being self-reported or according to the patient's electronic record.
• Unwilling to take home glucose measurements or to use the glucometer (for example because of severe hearing or visual impairment and without a caregiver to measure the blood glucose level by the glucometer)
• Unwilling to return for follow up.

Sponsors & Collaborators

• University of Lincoln: lead

Study Sites (1)

King Abdullah University Hospital

Irbid, 22110, Jordan

Location

Related Publications (2)

• Almomani HY, Ayre HM, Powell RA, Armani K. The SUGAR handshake intervention to prevent hypoglycaemia in elderly people with type 2 diabetes: process evaluation within a pragmatic randomised controlled trial. BMC Geriatr. 2025 Oct 1;25(1):753. doi: 10.1186/s12877-025-06361-2.

  PMID: 41034834 DERIVED

• Almomani HY, Pascual CR, Al-Azzam SI, Ahmadi K. Randomised controlled trial of pharmacist-led patient counselling in controlling hypoglycaemic attacks in older adults with type 2 diabetes mellitus (ROSE-ADAM): A study protocol of the SUGAR intervention. Res Social Adm Pharm. 2021 May;17(5):885-893. doi: 10.1016/j.sapharm.2020.07.012. Epub 2020 Jul 29.

  PMID: 32763086 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Keivan Ahmadi, PhD

  Associate Professor in Pharmacology & Therapeutics, Lincoln Medical School

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 9, 2019
• Study Start: February 9, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 22, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)