Diabetes Mellitus Type 2 With HypoglycemiaROSE-ADAMNCT04081766
Pharmacist-Led Study in Controlling Hypoglycemia in Older Adults With Type 2 Diabetes Mellitus
A study testing SUGAR Handshake in people with Diabetes Mellitus Type 2 With Hypoglycemia, run by University of Lincoln at 1 site in Jordan.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2 With Hypoglycemia
- What is being tested?
- SUGAR Handshake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteJordan
- Study dates
- 9 Feb 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Confirmed diagnosis of type 2 Diabetes Mellitus
- Have been taking a sulfonylurea, insulin, or any three or more anti-diabetic medications
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Pharmacist-Led Patient Counselling in Controlling Hypoglycemic Attacks in Older Adults With Type 2 Diabetes Mellitus
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.
Read more
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.
Read the detailed description
Hypoglycaemia is the most serious adverse effect of diabetes treatment. Older adults are at the highest risk to develop hypoglycaemia. Several studies have established the important positive role of educational interventions on achieving glycaemic control and other clinical outcomes, however, there is still a lack in clinical trials that evaluate the impact of such type of interventions on hypoglycaemia risk, especially in older adults. Despite the increasing prevalence of chronic diseases such as diabetes in Jordan, pharmacists still provide traditional services rather than patient-centred services.
The purpose of this research is to investigate the effect of pharmacist-led, individualised, and medications-focused patient counselling on reducing episodes of hypoglycaemia compared to the usual care in older Jordanians with type 2 Diabetes Mellitus within 12 weeks.
This research is a prospective, open-label, randomised controlled trial that is conducted in the outpatient endocrinology and cardiology clinics at King Abdullah University Hospital in Jordan, with 204 elderly patients who had been diagnosed with type 2 diabetes. Participants will be randomised in a 1:1 ratio into either the intervention (SUGAR Handshake) or the usual care groups. Each participant in the SUGAR Handshake group will receive a face-to-face individualised educational session with a pharmacist at the inclusion visit, a pictogram containing the main educational information, and a reinforcement of the educational session through a phone call at week 6 of the inclusion visit. They will also receive the usual care provided by the health care professionals at the outpatient clinics. On the other hand, patients in the usual care group will only receive the routine care provided at the outpatient clinics. The duration of the trial for each participant is 12 weeks.
The qualitative study is performed through phone interviews with 8-12 participants of each group at week 6 of the inclusion visit. Participants are to be approached according to convenience sampling and the data will be analysed using content analysis.
- Being tested
- SUGAR Handshake
- Keywords
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Hypoglycemia, Counseling, Older Adults
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUGAR HandshakeBehavioural
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:
- Signs and symptoms of hypoglycemia.
- Understanding the underlying causes of hypoglycaemia such as misuse of anti-diabetic medications.
- Good glycaemic control and self-monitoring, which mainly includes instructions on handling the anti-diabetic medications.
- Acknowledgement by the patient
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (5)
Frequency of severe hypoglycaemia
The frequency of severe hypoglycemia will be calculated as the number of severe hypoglycemic episodes/person/ 12 weeks. Severe hypoglycemia is defined as any event requiring the assistance of another person to administer carbohydrate and glucagon or take any other corrective actions, accompanied by neurological recovery after the corrective actions.
Participants will be provided with diaries to document severe episodes of hypoglycemia
Measured: 12 weeks
Frequency of asymptomatic hypoglycemia
The frequency of asymptomatic hypoglycemia will be calculated as the number of asymptomatic hypoglycaemia episodes/person/ 12 weeks. asymptomatic hypoglycaemia is defined as an event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L).
Participants will be provided with diaries to document fasting blood glucose levels by which asymptomatic episodes will be diagnosed.
Measured: 12 weeks
Frequency of symptomatic hypoglycemia
The frequency of symptomatic hypoglycemia will be calculated as the number of symptomatic hypoglycemic episodes/person/ 12 weeks. Symptomatic hypoglycemia is defined as an event during which the patient experiences typical symptoms of hypoglycaemia (sweating, dizziness, light-headedness, tremor, hunger, headache) whether they are accompanied by a measured plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L) or not.
Participants will be provided with diaries to document symptomatic episodes of hypoglycemia.
Measured: 12 weeks
Proportion of patients experiencing hypoglycaemia
proportion of patients who experience at least one hypoglycaemic attack of each type
Measured: 12 weeks
Time to the first hypoglycaemic attack
the number of the day when a participant will experience the first hypoglycaemic attack of any type after randomisation.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start9 Feb 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2 With HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lincoln
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keivan Ahmadi, PhD, Study director, Associate Professor in Pharmacology & Therapeutics, Lincoln Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081766
- Sponsor's protocol ID
- 2019-May-0170
- Acronym
- ROSE-ADAM
- Status last verified
- Nov 2020
- First submitted
- 4 Sep 2019
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41034834Almomani 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.
PubMed 32763086
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Pharmacist-Led Patient Counselling in Controlling Hypoglycemic Attacks in Older Adults With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04081766
- Acronym / sponsor ID
- ROSE-ADAM / 2019-May-0170
- Keywords
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Hypoglycemia, Counseling, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- University of LincolnUniversity, hospital or other
- Study start
- 9 Feb 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hypoglycaemia is the most serious adverse effect of diabetes treatment. Older adults are at the highest risk to develop hypoglycaemia. Several studies have established the important positive role of educational interventions on achieving glycaemic control and other clinical outcomes, however, there is still a lack in clinical trials that evaluate the impact of such type of interventions on hypoglycaemia risk, especially in older adults. Despite the increasing prevalence of chronic diseases such as diabetes in Jordan, pharmacists still provide traditional services rather than patient-centred services.
The purpose of this research is to investigate the effect of pharmacist-led, individualised, and medications-focused patient counselling on reducing episodes of hypoglycaemia compared to the usual care in older Jordanians with type 2 Diabetes Mellitus within 12 weeks.
This research is a prospective, open-label, randomised controlled trial that is conducted in the outpatient endocrinology and cardiology clinics at King Abdullah University Hospital in Jordan, with 204 elderly patients who had been diagnosed with type 2 diabetes. Participants will be randomised in a 1:1 ratio into either the intervention (SUGAR Handshake) or the usual care groups. Each participant in the SUGAR Handshake group will receive a face-to-face individualised educational session with a pharmacist at the inclusion visit, a pictogram containing the main educational information, and a reinforcement of the educational session through a phone call at week 6 of the inclusion visit. They will also receive the usual care provided by the health care professionals at the outpatient clinics. On the other hand, patients in the usual care group will only receive the routine care provided at the outpatient clinics. The duration of the trial for each participant is 12 weeks.
The qualitative study is performed through phone interviews with 8-12 participants of each group at week 6 of the inclusion visit. Participants are to be approached according to convenience sampling and the data will be analysed using content analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SUGAR Handshake | Active comparator | Behavioral: SUGAR HandshakeParticipants 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of type 2 Diabetes Mellitus
- Have been taking a sulfonylurea, insulin, or any three or more anti-diabetic medications
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUGAR HandshakeAn 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. | Behavioural | SUGAR Handshake |
Primary outcome
Frequency of total episodes of hypoglycaemia
Time frame: 12 weeks
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.
5 secondary outcomes
Frequency of severe hypoglycaemia
Time frame: 12 weeks
Frequency of asymptomatic hypoglycemia
Time frame: 12 weeks
Frequency of symptomatic hypoglycemia
Time frame: 12 weeks
Proportion of patients experiencing hypoglycaemia
Time frame: 12 weeks
Time to the first hypoglycaemic attack
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Derived from this study: PubMed 41034834Almomani 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.
- Derived from this study: PubMed 32763086Almomani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keivan Ahmadi, PhD study director
Associate Professor in Pharmacology & Therapeutics, Lincoln Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SUGAR Handshake in people with Diabetes Mellitus Type 2 With Hypoglycemia, run by University of Lincoln at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of total episodes of hypoglycaemia (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04081766, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021.