Diabetes Mellitus, Type 1Phase 4HumAn-1NCT05614089
Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings
A Phase 4 study testing Insulin Glargine and NPH or premixed 70/30 (human insulin) in people with Diabetes Mellitus, Type 1 and Type 1 Diabetes, run by Jing Luo at 3 sites in 2 countries.
Trial summary
The primary objective of this trial is to determine whether insulin glargine reduces the risk of serious hypoglycemia or improves Time in Range at 6 months when compared against standard of care human insulin (e.g. NPH or premixed 70/30) among youth living with type 1 diabetes (T1D) in low resource settings. Read more about this study
- Who is it for?
- Ages 7 to 25 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Type 1 Diabetes
- What is being tested?
- Insulin Glargine and NPH or premixed 70/30 (human insulin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 15 Mar 2023to 19 Mar 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children and young adults (age 7-25)
- Have a clinical diagnosis of type 1 diabetes (T1D)
Who cannot join
- Prior use of any insulin analogue
- Patients (or parents for children <18 years old) who refuse to or cannot provide informed consent
- Who are currently pregnant or plan to become pregnant over the next year
- Who have previously used a continuous glucose monitor (CGM) for glucose monitoring
- Who were first diagnosed with T1D less than 12 months ago
- Who is diagnosed with severe malnutrition
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings: A Randomized Controlled Trial
The primary objective of this trial is to determine whether insulin glargine reduces the risk of serious hypoglycemia or improves Time in Range at 6 months when compared against standard of care human insulin (e.g. NPH or premixed 70/30) among youth living with type 1 diabetes (T1D) in low resource settings.
Read the detailed description
Long-acting insulin analogues have become a de-facto standard of care for patients with T1D living in high-income countries. Unfortunately, insulin analogues remain unavailable or unaffordable for much of the global population. In both 2017 and 2019, applications to add long-acting insulin analogues to the WHO's Model List of Essential Medicines (EML) were rejected due to insufficient evidence of superiority and an unfavorable cost-effectiveness profile when compared against older, less expensive, human insulins (e.g., NPH insulin and premixed 70/30 insulin). In 2021, long-acting insulin analogues were added to the EML but the decision remains controversial since the WHO concluded that "magnitude of clinical benefit of long-acting insulin analogues over human insulin for most clinical outcomes was small." Moreover, studies that compare long-acting insulin analogues versus human insulins conducted in high-income settings may not generalize to children and young adults living with T1D in very low-resource settings.
To address this unmet need, Pitt has partnered with Brigham and Women's Hospital, The London School of Hygiene and Tropical Medicine, the Clinton Health Access Initiative and Life For a Child to conduct a randomized controlled trial comparing insulin glargine, a long-acting analogue insulin, against intermediate human insulin among 400 children and young adults living with T1D in a lower resource setting.
Note: In preparation for results submission, we made minor changes to the outcomes sections to reflect what is listed in the protocol.
For Primary Outcomes #1 and #2, and Secondary Outcomes #3,#4, #5, #7, #8: we added 12 months measurements (in addition to the 6 months measurement). We updated Secondary Outcome #9 to specify the PedsQL Diabetes Symptoms Score. We added Secondary Outcome #10 to include the PedsQL Diabetes Management Score. We added Secondary Outcome #11 for ITSQ scores.
- Conditions
- Diabetes Mellitus, Type 1, Type 1 Diabetes
- Being tested
- Insulin Glargine, NPH or premixed 70/30 (human insulin)
- Keywords
- Type 1 Diabetes, Insulin Glargine, Human Insulin, Insulin Analogue, Bangladesh, Tanzania
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin GlargineDrug
Formulation: Available as a clear liquid in a glass cartridge (1 cartridge =3ml=300 units).
Route: Reusable pen
Amount of each dose: varies depending on baseline basal insulin needs
Dose escalation scheme: Participants randomly assigned to glargine will start with a dose that is generally equal to 80% of their total basal human insulin dose prior to the switch (per ISPAD guidelines and the switching guide developed by Life for a Child with the guidance of Dr. Ragnar Hanas and two other ISPAD members familiar with less-resourced settings).
Frequency of dose: once per day (usually administered before bedtime)
Duration of therapy: 12 months
NPH or premixed 70/30 (human insulin)Drug
Formulation: Available as a liquid in a glass cartridge (3ml=300IU) or as liquid in a prefilled, disposable pen (3ml=300IU).
Route: Bangladesh = reusable pens; Tanzania = disposable pens
Amount of each dose: varies depending on baseline basal insulin needs (per usual care or treating clinician)
Frequency of dose: once or twice per day (per usual care or treating clinician)
Duration of therapy: 12 months
| Study group | Role | What they receive |
|---|---|---|
| Glargine | Experimental | Insulin glargine (long-acting insulin analogue) Receives: Drug: Insulin Glargine |
| NPH or premixed 70/30 (human insulin) | Active comparator | NPH or premixed 70/30 (human insulin) Receives: Drug: NPH or premixed 70/30 (human insulin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-in-serious Hypoglycemia
% time spent less than 54 mg/dl averaged across all daily measures. For 6-month outcome, these data were averaged across two CGM sensors (placed at 6 and 6.5 months). For 12-month outcome, these data were from one CGM sensor placed at 11.5 months.
Measured: 6 and 12 months after randomization
Time-in-range (TIR)
% time spent between 70 and 180mg/dl inclusive averaged across all daily measures. For 6-month outcome, these data were averaged across two CGM sensors (placed at 6 and 6.5 months). For 12-month outcome, these data were from one CGM sensor placed at 11.5 months.
Measured: 6 and 12 months after randomization
Secondary outcomes (9)
Time-in-hypoglycemia
% time spent less than 70mg/dl averaged across all daily measures. For 6-month outcome, these data were averaged across two CGM sensors (placed at 6 and 6.5 months). For 12-month outcome, these data were from one CGM sensor placed at 11.5 months.
Measured: 6 and 12 months after randomization
Time-above-range
% time spent greater than 180mg/dl averaged across all daily measures. For 6-month outcome, these data were averaged across two CGM sensors (placed at 6 and 6.5 months). For 12-month outcome, these data were from one CGM sensor placed at 11.5 months.
Measured: 6 and 12 months after randomization
Nocturnal Hypoglycemic Events
Number of events defined as ≥15 minutes in duration <70 mg/dL between midnight and 6:00 am; specifically, at least 2 sensor values <70 mg/dL that are ≥15 minutes apart plus no intervening values ≥70 mg/dL For 6-month outcome, these data were averaged across two CGM sensors (placed at 6 and 6.5 months). For 12-month outcome, these data were from one CGM sensor placed at 11.5 months.
Measured: 6 and 12 months after randomization
Glycemic Control (HbA1c)
Mean HbA1c lab result reported as percent, which is typically how it is reported.
Measured: baseline, 3, 6, 9 and 12 months after randomization
Rate of Severe Hypoglycemic Events
Severe hypoglycemic events (requiring assistance of another person to correct) reported by participant per 1000 person-years
Measured: 6 and 12 months after randomization
Rate of Diabetic Ketoacidosis (DKA)
Hospitalization or Emergency Room Visit (serious adverse event) with primary diagnosis of Diabetic Ketoacidosis. This was measured by self-report and confirmed through review of hospital records
Measured: 6 and 12 months after randomization
Pediatric Quality of Life Inventory 3.2 Diabetes Module (PedsQL 3.2 DM) Diabetes Symptoms Score
Mean PedsQL 3.2 DM Diabetes Symptoms score. PedsQL 3.2 DM Diabetes Symptoms scale is composed of 15 items. All items use the same 5-point Likert response scale, with responses ranging from "never" (0) to "almost always" (4). Items are reverse scored and transformed on a scale ranging from 0 to 100. The score is the sum of all the items over the number of items answered. Higher scores indicate fewer diabetes symptoms and therefore improved diabetes-specific health-related quality of life (D-HRQoL).
Measured: Baseline and at 6 and 12 months after randomization
Pediatric Quality of Life Inventory 3.2 Diabetes Module (PedsQL 3.2 DM) Diabetes Management Score
Mean PedsQL 3.2 DM Diabetes Management score. PedsQL 3.2 DM Diabetes Management scale is composed of 18 items. All items use the same 5-point Likert response scale, with responses ranging from "never" (0) to "almost always" (4). Items are reverse scored and transformed on a scale ranging from 0 to 100. Higher scores indicate fewer diabetes management problems and therefore improved D-HRQoL.
Measured: Baseline and at 6 and 12 months after randomization
Insulin Treatment Satisfaction Questionnaire (ITSQ) Scores
The ITSQ is composed of 22 items. A total 22-item score is reported, and the items are also divided into five subscales: Regimen Inconvenience (5 items), Lifestyle Flexibility (3 items), Glycemic Control (3 items), Hypoglycemic Control (5 items), and Insulin Delivery Device Satisfaction (6 items). Items use 7-point Likert scale responses, ranging from 1 (positive, e.g. "No bother at all") to 7 (negative, e.g. "A tremendous bother"), though the specific response labels vary by question. Items were reverse scored and transformed to range from 0 to 100. Higher scores indicate higher treatment satisfaction.
Measured: Baseline and at 6 and 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start15 Mar 2023
- Primary completion13 Aug 2024
- Study completion19 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jing Luo
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Responsible party
- Sponsor-investigator, Jing Luo, University of Pittsburgh
- Investigators
- Jing Luo, MD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614089
- Sponsor's protocol ID
- STUDY21110122
- Acronym
- HumAn-1
- Status last verified
- Sep 2025
- First submitted
- 28 Oct 2022
- Last updated
- 10 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified, summary level data will be shared with other researchers, upon request.
Publications
Luo J, Kehlenbrink S, Chang CH, Lalama CM, Kirsch J, Ansbro E, Prust ML, Garvin A, Zabeen B, Majaliwa E, Ramaiya K, Kayange N, Foulds A, Flabe AH, Nyarubamba RF, Rollman BL, Ogle GD. Human versus analogue insulin for children and young adults with type 1 diabetes in low-resource settings (HumAn-1): a multicentre, open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2026 Jul 6:S2213-8587(26)00097-5. doi: 10.1016/S2213-8587(26)00097-5. Online ahead of print.
PubMed 42409045Foulds A, Josey C, Kehlenbrink S, Rollman BL, Chang CH, Lalama C, Ansbro E, Prust ML, Zabeen B, Ramaiya K, Ogle G, Chae SR, Luo J. Human versus Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings (HumAn-1): protocol for a randomised controlled trial. BMJ Open. 2025 Jan 30;15(1):e092432. doi: 10.1136/bmjopen-2024-092432.
PubMed 39890140
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05614089
- Acronym / sponsor ID
- HumAn-1 / STUDY21110122
- Conditions
- Diabetes Mellitus, Type 1, Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Insulin Glargine, Human Insulin, Insulin Analogue, Bangladesh, Tanzania
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Jing LuoUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 19 Mar 2025 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Posted 10 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to determine whether insulin glargine reduces the risk of serious hypoglycemia or improves Time in Range at 6 months when compared against standard of care human insulin (e.g. NPH or premixed 70/30) among youth living with type 1 diabetes (T1D) in low resource settings.
Detailed description
Long-acting insulin analogues have become a de-facto standard of care for patients with T1D living in high-income countries. Unfortunately, insulin analogues remain unavailable or unaffordable for much of the global population. In both 2017 and 2019, applications to add long-acting insulin analogues to the WHO's Model List of Essential Medicines (EML) were rejected due to insufficient evidence of superiority and an unfavorable cost-effectiveness profile when compared against older, less expensive, human insulins (e.g., NPH insulin and premixed 70/30 insulin). In 2021, long-acting insulin analogues were added to the EML but the decision remains controversial since the WHO concluded that "magnitude of clinical benefit of long-acting insulin analogues over human insulin for most clinical outcomes was small." Moreover, studies that compare long-acting insulin analogues versus human insulins conducted in high-income settings may not generalize to children and young adults living with T1D in very low-resource settings.
To address this unmet need, Pitt has partnered with Brigham and Women's Hospital, The London School of Hygiene and Tropical Medicine, the Clinton Health Access Initiative and Life For a Child to conduct a randomized controlled trial comparing insulin glargine, a long-acting analogue insulin, against intermediate human insulin among 400 children and young adults living with T1D in a lower resource setting.
Note: In preparation for results submission, we made minor changes to the outcomes sections to reflect what is listed in the protocol.
For Primary Outcomes #1 and #2, and Secondary Outcomes #3,#4, #5, #7, #8: we added 12 months measurements (in addition to the 6 months measurement). We updated Secondary Outcome #9 to specify the PedsQL Diabetes Symptoms Score. We added Secondary Outcome #10 to include the PedsQL Diabetes Management Score. We added Secondary Outcome #11 for ITSQ scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glargine | Experimental | Drug: Insulin GlargineInsulin glargine (long-acting insulin analogue) |
| NPH or premixed 70/30 (human insulin) | Active comparator | Drug: NPH or premixed 70/30 (human insulin)NPH or premixed 70/30 (human insulin) |
Who may qualify
- Ages
- 7 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children and young adults (age 7-25)
- Have a clinical diagnosis of type 1 diabetes (T1D)
Key exclusion criteria (6 listed)
- Prior use of any insulin analogue
- Patients (or parents for children <18 years old) who refuse to or cannot provide informed consent
- Who are currently pregnant or plan to become pregnant over the next year
- Who have previously used a continuous glucose monitor (CGM) for glucose monitoring
- Who were first diagnosed with T1D less than 12 months ago
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 |
|---|---|---|
| Insulin GlargineFormulation: Available as a clear liquid in a glass cartridge (1 cartridge =3ml=300 units). Route: Reusable pen Amount of each dose: varies depending on baseline basal insulin needs Dose escalation scheme: Participants randomly assigned to glargine will start with a dose that is generally equal to 80% of their total basal human insulin dose prior to the switch (per ISPAD guidelines and the switching guide developed by Life for a Child with the guidance of Dr. Ragnar Hanas and two other ISPAD members familiar with less-resourced settings). Frequency of dose: once per day (usually administered before bedtime) Duration of therapy: 12 months | Drug | Glargine |
| NPH or premixed 70/30 (human insulin)Formulation: Available as a liquid in a glass cartridge (3ml=300IU) or as liquid in a prefilled, disposable pen (3ml=300IU). Route: Bangladesh = reusable pens; Tanzania = disposable pens Amount of each dose: varies depending on baseline basal insulin needs (per usual care or treating clinician) Frequency of dose: once or twice per day (per usual care or treating clinician) Duration of therapy: 12 months | Drug | NPH or premixed 70/30 (human insulin) |
Primary outcome
Time-in-serious Hypoglycemia
Time frame: 6 and 12 months after randomization
% time spent less than 54 mg/dl averaged across all daily measures. For 6-month outcome, these data were averaged across two CGM sensors (placed at 6 and 6.5 months). For 12-month outcome, these data were from one CGM sensor placed at 11.5 months.
Time-in-range (TIR)
Time frame: 6 and 12 months after randomization
% time spent between 70 and 180mg/dl inclusive averaged across all daily measures. For 6-month outcome, these data were averaged across two CGM sensors (placed at 6 and 6.5 months). For 12-month outcome, these data were from one CGM sensor placed at 11.5 months.
9 secondary outcomes
Time-in-hypoglycemia
Time frame: 6 and 12 months after randomization
Time-above-range
Time frame: 6 and 12 months after randomization
Nocturnal Hypoglycemic Events
Time frame: 6 and 12 months after randomization
Glycemic Control (HbA1c)
Time frame: baseline, 3, 6, 9 and 12 months after randomization
Rate of Severe Hypoglycemic Events
Time frame: 6 and 12 months after randomization
Rate of Diabetic Ketoacidosis (DKA)
Time frame: 6 and 12 months after randomization
Pediatric Quality of Life Inventory 3.2 Diabetes Module (PedsQL 3.2 DM) Diabetes Symptoms Score
Time frame: Baseline and at 6 and 12 months after randomization
Pediatric Quality of Life Inventory 3.2 Diabetes Module (PedsQL 3.2 DM) Diabetes Management Score
Time frame: Baseline and at 6 and 12 months after randomization
Insulin Treatment Satisfaction Questionnaire (ITSQ) Scores
Time frame: Baseline and at 6 and 12 months after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42409045Luo J, Kehlenbrink S, Chang CH, Lalama CM, Kirsch J, Ansbro E, Prust ML, Garvin A, Zabeen B, Majaliwa E, Ramaiya K, Kayange N, Foulds A, Flabe AH, Nyarubamba RF, Rollman BL, Ogle GD. Human versus analogue insulin for children and young adults with type 1 diabetes in low-resource settings (HumAn-1): a multicentre, open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2026 Jul 6:S2213-8587(26)00097-5. doi: 10.1016/S2213-8587(26)00097-5. Online ahead of print.
- Derived from this study: PubMed 39890140Foulds A, Josey C, Kehlenbrink S, Rollman BL, Chang CH, Lalama C, Ansbro E, Prust ML, Zabeen B, Ramaiya K, Ogle G, Chae SR, Luo J. Human versus Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings (HumAn-1): protocol for a randomised controlled trial. BMJ Open. 2025 Jan 30;15(1):e092432. doi: 10.1136/bmjopen-2024-092432.
- Individual participant dataSharing planned: Yes. De-identified, summary level data will be shared with other researchers, upon request.
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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.
Jing Luo, MD, MPH principal investigator
University of Pittsburgh
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin Glargine and NPH or premixed 70/30 (human insulin) in people with Diabetes Mellitus, Type 1 and Type 1 Diabetes, run by Jing Luo at 3 sites in 2 countries.
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 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Tanzania, Bangladesh. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time-in-serious Hypoglycemia (time frame: 6 and 12 months after randomization). The study lists 2 primary outcomes in all. 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 NCT05614089, 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 10 Sep 2025.