Hypoglycemia Non DiabeticsNCT02989675
SugarFACT - Sugar Requirements For African Children Trial
A study testing 10% dextrose in people with Hypoglycemia Non Diabetics and Emergencies, run by Helena Hildenwall at 2 sites in Malawi.
Trial summary
The purpose of this study is to evaluate the impact of dextrose administration in severely sick children admitted to hospital with low-glycaemia. The problem: Mortality in children remains high in sub-Saharan African hospitals. Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Hypoglycemia Non Diabetics, Emergencies, Pediatric ALL
- What is being tested?
- 10% dextrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 2 sitesMalawi
- Study dates
- Dec 2016to 22 Jan 2019
- 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 1 month to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between one month to 5 years (5 to 12 years for outcome measure no 3)
- Parent/carer willing and able to give consent
- Presence of one or several emergency signs (as defined in WHO pocket book of hospital care for children)
- Obstructed or absent breathing
- Central cyanosis
- Severe respiratory distress
Show all 12Show fewer
- Shock/impaired perfusion
- Coma/reduced consciousness
- Convulsions
- Severe dehydration
- Clinical concern that the child is in an emergency state
- Blood glucose 2.5-5.0mmol/l at arrival to the emergency department (3.0-5.0mmol/l for severely malnourished children). For outcome measure no 4 children with <2.5 mmol/l on arrival who then have 2.5-5.0 mmol/l on the repeat test 30 minutes later are also included
Who cannot join
- Children with a known diagnosis of diabetes
- Refusal to participate by the child or guardians
Trial locations and contacts
2 sites in 1 country.
Malawi2 sites
Queen Elisabeth Central Hospital
Blantyre
Zomba Central Hospital
Zomba
About this study
The purpose of this study is to evaluate the impact of dextrose administration in severely sick children admitted to hospital with low-glycaemia.
The problem: Mortality in children remains high in sub-Saharan African hospitals. While antimalarial drugs, antibiotics and other definitive treatments are well understood, the role of emergency care with supportive therapies such as maintaining normal glucose and electrolyte balances, has been given limited attention. Hypoglycaemia is common in children admitted to hospital in low-income settings. The current definition of hypoglycaemia is a blood glucose level of less than 2.5mmol/l. Outcomes for these children are poor, with a mortality rate of up to 42%. An increased mortality has also been reported among acutely ill children with low-glycaemia, defined as a blood glucose level of 2.5-5.0mmol/l. The reason for increased mortality rates is not fully understood.
Read more
Study objective: To determine the impact on mortality of a raised treatment cut-off level for paediatric hypoglycaemia, from 2.5mmol/l to 5.0mmol/l.
Methodology: Severely ill children admitted to two central Malawian hospitals; Queen Elisabeth Central Hospital, Blantyre and Zomba Central Hospital, with low-glycaemia (2.5-5.0mmol/l) will be randomised into intervention or control groups. The intervention group will be treated with an intravenous bolus of 10% dextrose 5ml/kg followed by a dextrose infusion in addition to standard care while the control group will receive standard care only. Children will be followed until discharge from hospital or death. Primary end-point is in-hospital mortality.
Read the detailed description
Enrolment started at Queen Elisabeth Central Hospital on Dec 5th 2016. Due to a slow enrolment rate a second site at Zomba Central Hospital has been opened to start enrolment on October 17th, 2017 in order for the project to be completed in December 2019.
- Being tested
- 10% dextrose
- Keywords
- pediatric, critical illness, Malawi
- Medical subject headings
- Emergencies, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% dextroseDrug
Bolus of 10% dextrose 5mls/kg
| Study group | Role | What they receive |
|---|---|---|
| Dextrose | Experimental | Children in the intervention group will immediately receive intravenous 5ml/kg 10% dextrose, Dextrose administration will continue as a maintenance infusion of intravenous 10% dextrose for 24 hours at standard maintenance rates. Capillary blood glucose monitoring will be repeated at 30 minute intervals with repeated equivalent bolus doses given until levels reach ≥5.0mmol/l. All children will be kept in the emergency department for a minimum of 60 minutes and have their vital signs checked at discharge from the emergency room to the ward. Receives: Drug: 10% dextrose |
| Control | No intervention | Usual care - the care that is currently provided in the hospital - will be provided. All children in the control group will be kept in the emergency department for a minimum of 60 minutes and have their vital signs checked at discharge from the emergency room to the ward. |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality in children 1 month to 5 years old
From date of randomization until the date of discharge from hospital or date of in-hospital death, whichever came first, assessed up to 12 months
Measured: Up to 12 months
Secondary outcomes (1)
24 hours mortality in children 1 month to 5 years old
Mortality within the first 24 hrs after admission
Measured: 24 hours after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion22 Jan 2019
- Study completion22 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypoglycemia Non DiabeticsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helena Hildenwall
- Sponsor type
- University, hospital or other
- Collaborators
- Kamuzu University of Health Sciences
- Responsible party
- Sponsor-investigator, Helena Hildenwall, Karolinska Institutet
- Investigators
- Helena Hildenwall, MD, PhD, Principal investigator, Karolinska InstitutetTim Baker, MD, PhD, Principal investigator, Karolinska InstitutetQueen Dube, MD, PhD, Principal investigator, College of Medicine, MalawiJosephine Langton, MD, Principal investigator, College of Medicine, Malawi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989675
- Sponsor's protocol ID
- P.01/16/1852
- Status last verified
- Feb 2019
- First submitted
- 5 Dec 2016
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ngwalangwa F, Nyaika M, Baker T, Dube Q, Langton J, Hildenwall H. Mortality impact of an increased blood glucose cut-off level for hypoglycaemia treatment in severely sick children aged 5 to 12 years in Malawi - an exploratory randomised controlled study. BMC Pediatr. 2026 Mar 3;26(1):276. doi: 10.1186/s12887-026-06660-6.
PubMed 41776474Baker T, Ngwalangwa F, Masanjala H, Dube Q, Langton J, Marrone G, Hildenwall H. Effect on mortality of increasing the cutoff blood glucose concentration for initiating hypoglycaemia treatment in severely sick children aged 1 month to 5 years in Malawi (SugarFACT): a pragmatic, randomised controlled trial. Lancet Glob Health. 2020 Dec;8(12):e1546-e1554. doi: 10.1016/S2214-109X(20)30388-0. Epub 2020 Oct 8.
PubMed 33038950Baker T, Dube Q, Langton J, Hildenwall H. Mortality impact of an increased blood glucose cut-off level for hypoglycaemia treatment in severely sick children in Malawi (SugarFACT trial): study protocol for a randomised controlled trial. Trials. 2018 Jan 11;19(1):33. doi: 10.1186/s13063-017-2411-8.
PubMed 29325595
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SugarFACT - Sugar Requirements For African Children Trial
- ClinicalTrials.gov ID
- NCT02989675
- Acronym / sponsor ID
- P.01/16/1852
- Keywords
- pediatric, critical illness, Malawi
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Helena HildenwallUniversity, hospital or other
- Collaborators
- Kamuzu University of Health Sciences
- Study start
- Dec 2016
- Primary completion
- 22 Jan 2019 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 12 Dec 2016 (estimated)
- 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.
The purpose of this study is to evaluate the impact of dextrose administration in severely sick children admitted to hospital with low-glycaemia.
The problem: Mortality in children remains high in sub-Saharan African hospitals. While antimalarial drugs, antibiotics and other definitive treatments are well understood, the role of emergency care with supportive therapies such as maintaining normal glucose and electrolyte balances, has been given limited attention. Hypoglycaemia is common in children admitted to hospital in low-income settings. The current definition of hypoglycaemia is a blood glucose level of less than 2.5mmol/l. Outcomes for these children are poor, with a mortality rate of up to 42%. An increased mortality has also been reported among acutely ill children with low-glycaemia, defined as a blood glucose level of 2.5-5.0mmol/l. The reason for increased mortality rates is not fully understood.
Study objective: To determine the impact on mortality of a raised treatment cut-off level for paediatric hypoglycaemia, from 2.5mmol/l to 5.0mmol/l.
Methodology: Severely ill children admitted to two central Malawian hospitals; Queen Elisabeth Central Hospital, Blantyre and Zomba Central Hospital, with low-glycaemia (2.5-5.0mmol/l) will be randomised into intervention or control groups. The intervention group will be treated with an intravenous bolus of 10% dextrose 5ml/kg followed by a dextrose infusion in addition to standard care while the control group will receive standard care only. Children will be followed until discharge from hospital or death. Primary end-point is in-hospital mortality.
Detailed description
Enrolment started at Queen Elisabeth Central Hospital on Dec 5th 2016. Due to a slow enrolment rate a second site at Zomba Central Hospital has been opened to start enrolment on October 17th, 2017 in order for the project to be completed in December 2019.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dextrose | Experimental | Drug: 10% dextroseChildren in the intervention group will immediately receive intravenous 5ml/kg 10% dextrose, Dextrose administration will continue as a maintenance infusion of intravenous 10% dextrose for 24 hours at standard maintenance rates. Capillary blood glucose monitoring will be repeated at 30 minute intervals with repeated equivalent bolus doses given until levels reach ≥5.0mmol/l. All children will be kept in the emergency department for a minimum of 60 minutes and have their vital signs checked at discharge from the emergency room to the ward. |
| Control | No intervention | –Usual care - the care that is currently provided in the hospital - will be provided. All children in the control group will be kept in the emergency department for a minimum of 60 minutes and have their vital signs checked at discharge from the emergency room to the ward. |
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Age between one month to 5 years (5 to 12 years for outcome measure no 3)
- Parent/carer willing and able to give consent
- Presence of one or several emergency signs (as defined in WHO pocket book of hospital care for children)
- Clinical concern that the child is in an emergency state
- Blood glucose 2.5-5.0mmol/l at arrival to the emergency department (3.0-5.0mmol/l for severely malnourished children). For outcome measure no 4 children with <2.5 mmol/l on arrival who then have 2.5-5.0 mmol/l on the repeat test 30 minutes later are also included
Key exclusion criteria (2 listed)
- Children with a known diagnosis of diabetes
- Refusal to participate by the child or guardians
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 |
|---|---|---|
| 10% dextroseBolus of 10% dextrose 5mls/kg | Drug | Dextrose |
Primary outcome
In-hospital mortality in children 1 month to 5 years old
Time frame: Up to 12 months
From date of randomization until the date of discharge from hospital or date of in-hospital death, whichever came first, assessed up to 12 months
1 secondary outcome
24 hours mortality in children 1 month to 5 years old
Time frame: 24 hours after admission
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 41776474Ngwalangwa F, Nyaika M, Baker T, Dube Q, Langton J, Hildenwall H. Mortality impact of an increased blood glucose cut-off level for hypoglycaemia treatment in severely sick children aged 5 to 12 years in Malawi - an exploratory randomised controlled study. BMC Pediatr. 2026 Mar 3;26(1):276. doi: 10.1186/s12887-026-06660-6.
- Derived from this study: PubMed 33038950Baker T, Ngwalangwa F, Masanjala H, Dube Q, Langton J, Marrone G, Hildenwall H. Effect on mortality of increasing the cutoff blood glucose concentration for initiating hypoglycaemia treatment in severely sick children aged 1 month to 5 years in Malawi (SugarFACT): a pragmatic, randomised controlled trial. Lancet Glob Health. 2020 Dec;8(12):e1546-e1554. doi: 10.1016/S2214-109X(20)30388-0. Epub 2020 Oct 8.
- Derived from this study: PubMed 29325595Baker T, Dube Q, Langton J, Hildenwall H. Mortality impact of an increased blood glucose cut-off level for hypoglycaemia treatment in severely sick children in Malawi (SugarFACT trial): study protocol for a randomised controlled trial. Trials. 2018 Jan 11;19(1):33. doi: 10.1186/s13063-017-2411-8.
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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.
Helena Hildenwall, MD, PhD principal investigator
Karolinska Institutet
Tim Baker, MD, PhD principal investigator
Karolinska Institutet
Queen Dube, MD, PhD principal investigator
College of Medicine, Malawi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10% dextrose in people with Hypoglycemia Non Diabetics and Emergencies, run by Helena Hildenwall at 2 sites in Malawi.
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 12 inclusion and 2 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: stopped early, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malawi. 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 was stopped early. Results are not available in the source record.
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?
In-hospital mortality in children 1 month to 5 years old (time frame: Up to 12 months). 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 NCT02989675, which also lists 3 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 15 Feb 2019.